Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Feb. 25, 2019 | Jun. 30, 2018 | |
Document And Entity Information | |||
Entity Registrant Name | VBI Vaccines Inc/BC | ||
Entity Central Index Key | 764,195 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2018 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity a Well-known Seasoned Issuer | No | ||
Entity a Voluntary Filer | No | ||
Entity's Reporting Status Current | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Small Business Flag | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 107,583,032 | ||
Entity Common Stock, Shares Outstanding | 97,661,887 | ||
Trading Symbol | VBIV | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2,018 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
CURRENT ASSETS | ||
Cash | $ 59,270 | $ 67,694 |
Accounts receivable, net | 56 | 143 |
Inventory, net | 911 | 788 |
Prepaid expenses | 982 | 951 |
Other current assets | 512 | 850 |
Total current assets | 61,731 | 70,426 |
NON-CURRENT ASSETS | ||
Other long-term assets | 835 | 675 |
Property and equipment, net | 8,525 | 2,245 |
Intangible assets, net | 58,249 | 63,336 |
Goodwill | 8,265 | 8,974 |
Total non-current assets | 75,874 | 75,230 |
TOTAL ASSETS | 137,605 | 145,656 |
CURRENT LIABILITIES | ||
Accounts payable | 6,055 | 1,810 |
Other current liabilities | 13,847 | 9,826 |
Deferred revenues | 2,375 | |
Current portion of long-term debt, net of debt discount - related party | 1,100 | 1,600 |
Total current liabilities | 23,377 | 13,236 |
NON-CURRENT LIABILITIES | ||
Long-term debt, net of debt discount - related party | 12,927 | 11,538 |
Liabilities for severance pay | 371 | 426 |
Deferred revenues, net of current portion | 2,797 | 669 |
Total non-current liabilities | 16,095 | 12,633 |
COMMITMENTS AND CONTINGENCIES (NOTES 14 and 15) | ||
STOCKHOLDERS' EQUITY | ||
Common shares (unlimited authorized; no par value) (2018 issued - 97,343,777; 2017 - issued 64,078,781) | 246,417 | 201,806 |
Additional paid-in capital | 63,449 | 60,891 |
Accumulated other comprehensive (loss) income | (4,158) | 1,065 |
Accumulated deficit | (207,575) | (143,975) |
Total stockholders' equity | 98,133 | 119,787 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 137,605 | $ 145,656 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Statement of Financial Position [Abstract] | ||
Common stock, authorized unlimited | Unlimited | Unlimited |
Common stock, no par value | ||
Common stock, shares issued | 97,343,777 | 64,078,781 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Statement [Abstract] | ||
Revenues | $ 3,355 | $ 865 |
Operating expenses: | ||
Cost of revenues | 4,509 | 5,193 |
Research and development | 38,467 | 20,918 |
General and administration | 20,787 | 12,034 |
Total operating expenses | 63,763 | 38,145 |
Net loss from operations | (60,408) | (37,280) |
Interest expense, net (including related party - see Note 9) | (2,632) | (2,882) |
Foreign exchange (loss) gain | (560) | 736 |
Loss before incomes taxes | (63,600) | (39,426) |
Income tax benefit | 431 | |
NET LOSS | (63,600) | (38,995) |
Other comprehensive (loss) income - Currency translation adjustment | (5,223) | 4,261 |
COMPREHENSIVE LOSS | $ (68,823) | $ (34,734) |
Net loss per share of common shares, basic and diluted | $ (0.97) | $ (0.88) |
Weighted-average number of common shares outstanding, basic and diluted | 65,647,781 | 44,158,692 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Income (Loss) - 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 | ||||
Common shares issued in financing transaction | $ 67,222 | 67,222 | |||
Common shares issued in financing transaction, shares | 23,575,410 | ||||
Warrants issued in connection with financing transaction | $ (611) | 611 | |||
Common shares issued on settlement agreement with Kevelt | $ 1,142 | 1,142 | |||
Common shares issued on settlement agreement with Kevelt, shares | 274,000 | ||||
Warrant modification in connection with debt amendment | |||||
Stock-based compensation | $ 640 | 1,685 | 2,325 | ||
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 | ||||
Net loss | (38,995) | (38,995) | |||
Currency translation adjustments | 4,261 | 4,261 | |||
Balance at Dec. 31, 2017 | $ 201,806 | 60,891 | 1,065 | (143,975) | 119,787 |
Balance, Shares at Dec. 31, 2017 | 64,078,781 | ||||
Common shares issued in financing transaction | $ 39,780 | 39,780 | |||
Common shares issued in financing transaction, shares | 30,665,304 | ||||
Fair value of common shares issued as part of Brii Bio License Agreement | $ 3,626 | 3,626 | |||
Fair value of common shares issued as part of Brii Bio License Agreement, shares | 2,295,082 | ||||
Warrant modification in connection with debt amendment | 386 | 386 | |||
Stock-based compensation | $ 1,140 | 2,172 | 3,312 | ||
Stock-based compensation, shares | 264,782 | ||||
Common shares issued on exercise of stock options | $ 65 | 65 | |||
Common shares issued on exercise of stock options, shares | 39,828 | ||||
Net loss | (63,600) | (63,600) | |||
Currency translation adjustments | (5,223) | (5,223) | |||
Balance at Dec. 31, 2018 | $ 246,417 | $ 63,449 | $ (4,158) | $ (207,575) | $ 98,133 |
Balance, Shares at Dec. 31, 2018 | 97,343,777 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (63,600) | $ (38,995) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Depreciation and amortization | 542 | 730 |
Impairment of property and equipment | 278 | |
Impairment of intangible assets | 300 | |
Stock-based compensation | 3,312 | 2,410 |
Amortization of debt discount | 1,274 | 1,181 |
Deferred taxes | (431) | |
Inventory reserve | 189 | 217 |
Net change in operating working capital items: | ||
Decrease (increase) in accounts receivable | 79 | (127) |
Increase in inventory | (378) | (89) |
Increase in prepaid expenses | (285) | (265) |
Decrease (increase) in other current assets | 213 | (230) |
Increase in other long-term assets | (31) | (14) |
Increase (decrease) in accounts payable | 3,804 | (675) |
Increase (decrease) in deferred revenues | 4,924 | (107) |
Increase in other current liabilities | 4,146 | 4,714 |
Net cash flows used in operating activities | (45,533) | (31,381) |
INVESTING ACTIVITIES | ||
Changes in other long-term assets | 61 | |
Purchase of property and equipment | (5,993) | (640) |
Net cash flows used in investing activities | (5,993) | (579) |
FINANCING ACTIVITIES | ||
Proceeds from issuance of common shares for cash | 46,558 | 71,905 |
Share issuance costs | (3,006) | (4,683) |
Proceeds from issuance of common shares for cash, upon exercise of stock options | 65 | 16 |
Net cash flows provided by financing activities | 43,617 | 67,238 |
Effect of exchange rates on cash | (515) | 134 |
CHANGE IN CASH FOR THE YEAR | (8,424) | 35,412 |
CASH, BEGINNING OF YEAR | 67,694 | 32,282 |
CASH, END OF YEAR | 59,270 | 67,694 |
Supplementary information: | ||
Interest paid | 1,980 | 1,850 |
Non-cash investing and financing: | ||
Warrant modification in connection with debt amendment | 386 | |
Capital expenditures included in accounts payable and other current liabilities | 1,552 | 145 |
Share issuance costs included in accounts payable and other current liabilities | $ (146) |
Nature of Business and Continua
Nature of Business and Continuation of Business | 12 Months Ended |
Dec. 31, 2018 | |
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. (the “Company” or “VBI”) was incorporated under the laws of British Columbia, Canada on April 9, 1965. The Company and its 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 and the wholly-owned subsidiary of VBI US (“VBI Cda”); and SciVac Ltd. an Israeli company (“SciVac”) are collectively referred to as the “Company”, “we”, “us”, “our” or “VBI”. The Company’s registered office is located at Suite 1700, Park Place, 666 Burrard Street, Vancouver, BC V6C 2X8 with its principal office located at 222 Third Street, Suite 2241, Cambridge, MA 02142. In addition, the Company has manufacturing facilities located in Rehovot, Israel and research facilities located in Ottawa, Ontario, Canada. Principal Operations VBI is a commercial-stage, biopharmaceutical company developing next generation vaccines to address unmet needs in infectious disease and immuno-oncology. We currently manufacture our product, Sci-B-Vac a third generation prophylactic Hepatitis B (“HBV”) vaccine for adults, children and newborns, which is approved for use in Israel and 10 other countries. Sci-B-Vac has not yet been approved by the United States Food and Drug Administration (the “FDA”), the European Medicines Agency (the “EMA”) or Health Canada. VBI is currently conducting a global Phase III clinical program to obtain FDA, EMA and Health Canada market approvals for commercial sale of Sci-B-Vac in the United States, the European Union (the “EU”), and Canada, respectively. Our wholly-owned subsidiary in Rehovot, Israel, currently manufactures and sells Sci-B-Vac. We are also developing a protein-based immunotherapeutic for treatment of Hepatitis B in collaboration with Brii Biosciences Limited (“Brii Bio”). We are also developing technologies that seek to enhance vaccine protection in large, underserved markets. These include an enveloped “Virus Like Particle” or “eVLP” vaccine platform that allows for the design of enveloped virus-like particle vaccines that closely mimic the target viruses. VBI is advancing a pipeline of eVLP vaccines, with programs in human cytomegalovirus (“CMV”), an infection that, while common, can lead to serious complications in newborns and people with weakened immune systems, and glioblastoma multiforme (“GBM”), which is an aggressive form of adult brain cancer. 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 the development and commercialization of its products, 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 $207,575 as of December 31, 2018 and cash outflows from operating activities of $45,533, for the year-ended December 31, 2018. The Company will require significant additional funds to conduct clinical and non-clinical trials, achieve regulatory approvals, and, subject to such approvals, commercially launch its products. The Company plans to finance future operations with existing cash reserves. Additional financing, if required, will be a combination of proceeds from the issuance of equity securities, the issuance of additional debt, structured asset financings, and revenues from potential collaborations, if any. There is no assurance the Company will manage to obtain these sources of financing, if required. The above conditions raise substantial doubt about the Company’s ability to continue as a going concern. The 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 has a term of three years and expires on May 15, 2020; however 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 and there are no assurances as to how much, if any, funds will be raised under the Distribution Agreement. 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 for total gross proceeds of $71,905. 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 Company incurred $4,683 of cash issuance costs related to the offering resulting in net cash proceeds of $67,222. On December 4, 2018, the Company entered into a license and collaboration agreement (“License Agreement”) with Brii Bio, whereby we received a total upfront payment of $11,000 to collaborate on the development of a hepatitis B recombinant protein based immunotherapeutic in China, Hong Kong, Taiwan and Macau and to conduct a Phase II collaboration clinical trial. In connection with the License Agreement, we entered into a stock purchase agreement through which we issued to Brii Bio 2,295,082 common shares. See Note 11 and 12 for further discussion. On December 17, 2018, the Company closed an underwritten public offering of 30,665,304 common shares at a price of $1.40 per share for total gross proceeds of $42,932. The Company incurred $3,152 of share issuance costs related to the offering resulting in net cash proceeds of $39,780. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | 2. SIGNIFICANT ACCOUNTING POLICIES Basis of Consolidation The consolidated financial statements include the accounts of VBI and its wholly owned subsidiaries, SciVac, VBI DE, VBI US and VBI Cda. Intercompany balances and transactions between the Company and its subsidiaries are eliminated in the consolidated financial statements. Foreign currency The functional and reporting currency of the Company is the United States dollar. Each of the Company’s subsidiaries determines its own respective functional currency, based on the primary economic environment that it operates in, 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 other comprehensive loss /income. Foreign exchange gains and losses arising from transactions denominated in a currency other than the functional currency of the entity involved, are included in operating results. Use of Estimates Preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (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 consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual amounts could differ from the estimates made. We continually evaluate estimates used in the preparation of the 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 revenue recognition, determining the deferred tax valuation allowance, estimating accrued clinical expenses, the inputs in determining the fair value of the in-process research and development (“IPR&D”) and goodwill as part of the annual impairment analysis and the inputs in determining the fair value of equity-based awards and warrants issued. Actual results may differ from those estimates. Concentration of Credit Risk Financial instruments that potentially subject us to significant concentrations of credit risk consist principally of cash and accounts receivable. We place our cash primarily in commercial checking accounts. Commercial bank balances may from time to time exceed federal insurance limits. However, the Company believes credit risk is low as the cash resides in large highly rated financial institutions. The Company has not experienced any losses in cash and accounts receivable for years ended December 31, 2018 and 2017, respectively. Inventory Inventory components include all raw materials, work-in-progress and finished goods. Cost is determined on a first-in, first-out basis. Inventory is valued at the lower of cost or net realizable value. The cost of inventories comprises costs to purchase and costs incurred in bringing the inventories to their present location and condition. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. On an annual basis, the Company evaluates the condition and age of inventories and makes provisions for slow moving inventories accordingly. Deferred financing costs Offering costs related to debt and equity financing consist of direct incremental external expenses. The Company presents debt issuance costs related to a recognized long-term debt in the consolidated balance sheet as a direct deduction of the carrying value of the long-term debt, consistent with the accounting treatment of debt discounts. The amortization of debt issuance costs follows the effective interest rate method. Offering costs related to registration statements and the initiation of the Distribution Agreement are recorded as an asset and are reclassified to equity upon the successful selling of common shares. The costs are reviewed for impairment and will be recorded to expense if and when the Company determines that future equity offerings are not probable of occurring. At December 31, 2018 and 2017, the Company had $154 and $240 of deferred offering costs, respectively, recorded as an other current asset. Property and equipment Property and equipment are recorded at cost less accumulated depreciation. The assets are depreciated by the straight-line method, over the estimated useful lives of the related assets as follows. Number of years Furniture and office equipment 5-14 Machinery and equipment 3-7 Computers 2-3 Leasehold improvements shorter of useful life or the term of the lease When assets are retired or otherwise disposed of, the cost and the related accumulated depreciation is removed from the accounts, and any resulting gain or loss is recognized in the consolidated statement of operations and comprehensive loss. The cost of maintenance and repairs is charged to expense as incurred; significant renewals and betterments are capitalized. Impairment of long-lived assets Long-lived assets, such as property and equipment and finite-lived intangible assets, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. Recoverability of assets to be held and used is measured by comparison of the carrying amount of an asset to the estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of the asset exceeds its estimated future cash flows, then an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the asset. The Company recorded an impairment of $278 during the year ended December 31, 2018 related to certain leasehold improvements and manufacturing equipment no longer being utilized in the business as a result of the modernization and capacity increase of our manufacturing facility. The amount represented the remaining net book value of these assets. The impairment is included in general and administrative on the consolidated statements of operations and comprehensive loss. Goodwill and In-Process Research and Development (“IPR&D”) Assets The Company’s intangible assets determined to have indefinite useful lives including IPR&D and goodwill, are tested for impairment annually, or more frequently if events or circumstances indicate that the assets might be impaired. Such circumstances could include but are 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. 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. 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. Subsequently (if necessary after step zero), if the carrying value of a reporting unit exceeded its fair value an impairment would be recorded. We would perform our goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. The Company has established August 31st as the date for its annual impairment test of goodwill. There was no goodwill impairment determined as a result of the Company’s annual testing on August 31, 2018. The fair value of the Company, which consists of a single reporting unit, included in the impairment test was determined using the closing market stock price of VBI as of August 31, 2018. The goodwill is in VBI Cda and the change in carrying value from December 31, 2017 relates to currency translation adjustments which decreased goodwill by $709 for the year ended December 31, 2018. The change in carrying value from December 31, 2016 to December 31, 2017 relates to currency translation adjustments which increased goodwill by $589. 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. There was no IPR&D impairment determined as a result of the Company’s annual testing on August 31, 2018. The fair value of the IPR&D assets included in the impairment test on August 31, 2018 was determined using the income approach method and is considered Level 3 in the fair value hierarchy. Some of the more significant estimates and assumptions inherent in the estimate of the fair value of IPR&D assets include the amount and timing of costs to develop the IPR&D into viable products, the amount and timing of future cash inflows, the discount rate and the probability of technical and regulatory success applied to the cash flows. The discount rate used was 13.5% and the cumulative probability of technical and regulatory success to achieve approval to market the products ranged from approximately 6% to 25%. The IPR&D assets are in VBI Cda and the change in carrying value from December 31, 2017 relates to currency translation adjustments which decreased IPR&D assets by $4,976 for the year ended December 31, 2018. The change in carrying value from December 31, 2016 to December 31, 2017 relates to currency translation adjustments which increased IPR&D assets by $4,131. Other Intangible Assets The Company’s other intangible assets include patents with finite lives. These assets obtained are recorded at cost less accumulated amortization and any impairment losses. The Company amortizes intangible assets with finite lives on a straight-line basis over their estimated useful lives. Long Term Debt The Company accounts for amendments to long-term debt as a substantial modification if the present value of the cash flows under the terms of the new debt instrument is at least 10 percent different from the present value of the remaining cash flows under the terms of the original instrument. A substantial modification shall be accounted for like an extinguishment. If the cash flow effect on a present value basis is less than 10%, the debt instruments are accounted for as a debt modification. Research and development All costs of research and development are expensed as incurred. When preparing our financial statements, we are required to estimate our accrued clinical expenses. This process involves reviewing contracts and communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual cost. Payments under some of the contracts we have with third parties depend on factors, such as successful enrollment of certain numbers of patients, site initiation and the completion of clinical trial milestones. When accruing clinical expenses, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If possible, we obtain information regarding unbilled services directly from our service providers. However, we may be required to estimate the cost of these services based only on information available to us. If we underestimate or overestimate the cost associated with a trial or service at a given point in time, adjustments to research and development expenses may be necessary in future periods. Historically, our estimated accrued clinical expenses have approximated actual expense incurred. Revenue recognition Effective January 1, 2018, we adopted Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers (Topic 606) (“Topic 606”) using the modified retrospective method which consisted of applying and recognizing the cumulative effect of Topic 606 at the date of initial application. Topic 606 supersedes the revenue recognition requirements in Accounting Standards Codification (“ASC”) Topic 605, Revenue Recognition (“Topic 605”). There was no material impact on adoption to our consolidated financial statements related to the adoption of ASC 606. We recognize revenue when we transfer promised goods or services to customers in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenue when (or as) we satisfy the performance obligation(s). At contract inception, we assess the goods or services promised within each contract, assess whether each promised good or service is distinct and identify those that are performance obligations. The Company must use significant judgment to determine: a) the number of performance obligations based on the determination under step (ii) above and whether those performance obligations are distinct from other performance obligations in the contract; b) the transaction price under step (iii) above; and c) the stand-alone selling price for each performance obligation identified in the contract for the allocation of transaction price in step (iv) above. The Company uses judgment to determine whether milestones or other variable consideration, except for royalties, should be included in the transaction price. The transaction price is allocated to each performance obligation on an estimated stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. Where a portion of non-refundable up-front fees or other payments received are allocated to continuing performance obligations under the terms of a collaborative arrangement, they are recorded as contract liabilities and recognized as revenue when (or as) the underlying performance obligation is satisfied. Product sales The Company recognizes revenue from product sales when obligations under the terms of the contract with the customer are satisfied; this occurs with the transfer of control of the goods to the customers. Collaborative Arrangements We enter into collaborative arrangements, which are within the scope of ASC 606, with partners that typically include payment to us of one of more of the following: (i) license fees; (ii) research and development services to be performed as part of the contract (“R&D services”) (iii) payments related to the achievement of developmental, regulatory, or commercial milestones; and (iv) royalties on net sales of licensed products. The Company first evaluates license and/or collaboration arrangements to determine whether the arrangement (or part of the arrangement) represents a collaborative arrangement pursuant to ASC Topic 808, Collaborative Arrangements, based on the risks and rewards and activities of the parties pursuant to the contractual arrangement. The Company accounts for collaborative arrangements (or elements within the contract that are deemed part of a collaborative arrangement), which represent a collaborative relationship and not a customer relationship, outside the scope of ASC 606. The Company’s collaborations primarily represent revenue arrangements. License fees If a license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. R&D Services The promises under the Company’s collaboration and license agreements generally include research and development services to be performed by the Company. For performance obligations that include research and development services, the Company generally recognizes revenue allocated to such performance obligations based on an appropriate measure of progress. The Company utilizes judgment to determine the appropriate method of measuring progress for purposes of recognizing revenue, which is generally an input measure such as costs incurred. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Royalties For arrangements that include sales-based royalties, including milestone payments based on a level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from any of its licensing arrangements. Employee benefits The Company operates a defined contribution retirement benefit plan for all qualifying employees in accordance with Israeli law. The assets of the plan are held separately from those of the Company in funds under the control of trustees. The Company’s liability for severance pay for the employees of its subsidiary in Israel is calculated in accordance with Israeli law based on the most recent salary paid to employees and the length of employment in the Company. The Company records its obligation with respect to employee severance payments as if it were payable at each balance sheet date. Obligations for employee benefits are recognized as a component of operating expenses in the statement of operations and comprehensive loss in the periods during which services are rendered by employees. The Company records its obligation with respect to employee severance payments as if it was payable at each balance sheet date. Income taxes Deferred tax assets and liabilities are determined based on the differences between the financial reporting and tax basis of assets and liabilities using enacted tax rates which will be in effect when the differences reverse. The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax asset will be realized. The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities based on the technical merits of the position. The benefit is measured as the largest amount that is more likely than not to be realized upon ultimate settlement. The Company does not have any uncertain tax positions or accrued penalties and interest as at December 31, 2018 and 2017. If such matters were to arise, the Company would recognize interest and penalties related to income tax matters in income tax expense. The Company’s claim for Scientific Research and Experimental Development (SR&ED) deductions for income tax purposes are based upon management’s interpretation of the applicable legislation in the Income Tax Act (Canada). These amounts are subject to review and acceptance by the Canada Revenue Agency and may be subject to adjustment. 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. 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 consolidated balance sheet consist of cash, accounts receivable, other current assets, accounts payable and other current liabilities. The Company believes that the carrying value of its current 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 long-term financial assets approximate their respective fair values. The fair value of our outstanding debt, including the current portion, is estimated to be approximately $14,975 and $15,157 at December 31, 2018 and 2017, respectively. The fair value of the outstanding debt is considered to be Level 3 in the fair value hierarchy and was estimated by discounting to present value the scheduled coupon payments and principal repayment, using an appropriate fair market yield. Loss per share Basic loss per share is computed by dividing net loss by the weighted average number of shares outstanding during the period. Diluted loss per share is computed by dividing net loss by the weighted average number of shares outstanding and the impact of all dilutive potential shares. There is no dilutive effect on the earnings per share for all periods presented. Operating leases Operating lease payments are recognized as an expense on a straight-line basis over the lease term. Contingent rentals arising under operating leases are recognized as an expense in the period in which they are incurred. Stock-based compensation The Company accounts for share-based awards to employees and directors in accordance with the provisions of ASC 718, Compensation—Stock Compensation. Under ASC 718, share-based awards are valued at fair value on the date of grant and that fair value is recognized over the requisite service period. The Company values its stock options using the Black-Scholes option pricing model. The Company accounts for forfeitures when they occur. The Company accounts for share-based payments to non-employees issued in exchange for services based upon the fair value of the equity instruments issued. Compensation expense for stock options issued to non-employees is calculated using the Black-Scholes option pricing model and is recorded over the service performance period. Options subject to vesting are required to be periodically remeasured over their service performance period until the measurement date, when service is completed. |
New Accounting Pronouncements
New Accounting Pronouncements | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Changes and Error Corrections [Abstract] | |
New Accounting Pronouncements | 3. NEW ACCOUNTING PRONOUNCEMENTS Recently Adopted Accounting Pronouncements Revenue from Contracts with Customers In May 2014, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update No. 2014-09 , 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 as of the beginning of the fiscal year of adoption. Except for certain early application guidance, early adoption is not permitted. We adopted this ASU effective January 1, 2018 and are no longer required to disclose the fair value assumptions in determining the fair value of the long-term debt in the footnote disclosures. Collaborative Arrangements In November 2018, the FASB issued ASU 2018-18: Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606. This ASU provides guidance on whether certain transactions between collaborative arrangement participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account. Accordingly, this amendment added unit of account guidance in Topic 606 when an entity is assessing whether the collaborative arrangement or a part of the arrangement is within the scope of Topic 606. In addition, the amendment provides certain guidance on presenting the collaborative arrangement transaction together with Topic 606. ASU 2018-18 is effective for fiscal years beginning after December 15, 2019 and interim periods within those fiscal years. Early adoption is permitted. This ASU is to be applied retrospectively to the date of initial application of Topic 606. The Company has early adopted this ASU effective in the fourth quarter of 2018 with no impact on our consolidated financial statements and related footnote disclosures. Recently Issued Accounting Standards, not yet Adopted 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. The ASU addresses other concerns related to the current lease model. Under ASU 2016-02, lessees will be required to recognize for all leases with terms longer than 12 months, at the commencement date of the lease, a lease liability, which is a lessee’s obligation to make lease payments arising from a lease measured on a discounted basis, and a right-to-use asset, which is an asset that represents the lessee’s right to use or control the use of a specified asset for the lease term. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition. The update is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. In July 2018, the FASB issued ASU 2018-10 “Codification Improvements to Topic 842, Leases”. This ASU affects narrow aspects of the guidance issued in the amendments in ASU 2016-02 including those regarding residual value guarantees, rate implicit in the lease, lessee reassessment of lease classification, lessor reassessment of lease term and purchase option, variable lease payments that depend on an index or a rate, investment tax credits, lease term and purchase option, transition guidance for amounts previously recognized in business combinations, certain transition adjustments, transition guidance for leases previously classified as capital leases under Topic 840, transition guidance for modifications to leases previously classified as direct financing or sales-type leases under Topic 840, transition guidance for sale and leaseback transactions, impairment of net investment in the lease, unguaranteed residual asset, effect of initial direct costs on rate implicit in the lease, and failed sale and leaseback transactions. The Company will implement ASC 842 retrospectively with an application date of January 1, 2019 through a cumulative-effect adjustment to opening retained earnings while the comparative period presented in the financial statements and footnote disclosures will continue to be in accordance with Topic 840 – Leases. The Company will use the package of practical expedients relating to: 1) the need to re-assess expired or existing contracts that are or contain leases; 2) the need to reassess lease classification for any expired or existing leases; and 3) the need the reassess initial direct costs for existing leases. The Company expects to recognize right-of use assets and operating lease liabilities of approximately $1,620 on its consolidated balance sheet upon adoption on January 1, 2019. There will be no impact on opening retained earnings. Compensation – Stock Compensation In June 2018, the FASB issued ASU 2018-07: Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. This ASU expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from non-employees, and as a result, the accounting for share-based payments to non-employees will be substantially aligned. ASU 2018-07 is effective for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year, early adoption is permitted but no earlier than an entity’s adoption date of Topic 606. The Company does not believe there will be a material impact from the adoption of this new accounting guidance on our consolidated financial statements and related footnote disclosures. Intangibles – Goodwill and Other, Internal-Use Software In August 2018, the FASB issued ASU 2018-15: Intangibles – Goodwill and Other – Internal-Use Software (Subtopic 350-40): Customers’ accounting for implementation costs incurred in a cloud computing arrangement that is a service contract. This ASU aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. Accordingly, the amendments require an entity (customer) in a hosting arrangement that is a service contract to follow the guidance in Subtopic 350-40 to determine which implementation costs to capitalize as an asset related to the service contract and which costs to expense. ASU 2018-15 is effective for fiscal years beginning after December 15, 2019 and interim periods within those fiscal years. Early adoption is permitted. This ASU can be applied either retrospectively or prospectively to all implementation costs incurred after the date of adoption. The Company is currently evaluating the impact this new guidance will have on its financial statements and related disclosures. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 4. PROPERTY AND EQUIPMENT December 31, 2018 Cost Accumulated Depreciation Net Book Value Machinery and equipment $ 3,603 $ (1,046 ) $ 2,557 Furniture and office equipment 132 (41 ) 91 Computer equipment and software 384 (227 ) 157 Leasehold improvements 6,817 (1,097 ) 5,720 $ 10,936 $ (2,411 ) $ 8,525 December 31, 2017 Cost Accumulated Depreciation Net Book Value Machinery and equipment $ 1,748 $ (698 ) $ 1,050 Furniture and office equipment 92 (26 ) 66 Computer equipment and software 315 (140 ) 175 Leasehold improvements 2,453 (1,499 ) 954 $ 4,608 $ (2,363 ) $ 2,245 Depreciation expense for the years ended December 31, 2018, and 2017 was $481 and $667, respectively. |
Inventory, Net
Inventory, Net | 12 Months Ended |
Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Inventory, Net | 5. INVENTORY, NET Inventory is stated at the lower of cost or market and consists of the following: 2018 2017 Finished goods $ 81 $ 99 Work-in-process 64 119 Raw materials 766 570 $ 911 $ 788 The Company recorded a provision of approximately $189 and $217 as of December 31, 2018 and 2017, respectively. The provision is for inventory largely related to excess work-in process which is no longer expected to be used in the manufacturing process. |
Intangibles
Intangibles | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangibles | 6. INTANGIBLES December 31, 2018 Gross Carrying amount Accumulated Amortization Cumulative Impairment Charge Cumulative Currency Translation Net Book Value License $ 669 $ (457 ) $ - $ 11 $ 223 IPR&D assets 61,500 - (300 ) (3,174 ) 58,026 $ 62,169 $ (457 ) $ (300 ) $ (3,163 ) $ 58,249 December 31, 2017 Gross Carrying amount Accumulated Amortization Impairment Charge Cumulative Currency Translation Net Book Value License $ 669 $ (397 ) $ - $ 33 $ 305 IPR&D assets 61,500 - (300 ) 1,831 63,031 $ 62,169 $ (397 ) $ (300 ) $ 1,864 $ 63,336 The license is held in Israel at SciVac. Amortization expenses for the years ended December 31, 2018 and 2017 amounted to $61 and $63, respectively. Amortization is expected to be approximately $58 per year until its fully amortized. These amounts do not include any amortization related to the IPR&D assets, which will not begin amortizing until the Company commercializes its products. |
Other Current Liabilities
Other Current Liabilities | 12 Months Ended |
Dec. 31, 2018 | |
Other Liabilities Disclosure [Abstract] | |
Other Current Liabilities | 7. OTHER CURRENT LIABILITIES Other current liabilities consisted of the following: 2018 2017 Accrued research and development expenses (including clinical trial expenses) $ 9,763 $ 7,008 Payroll and employee-related costs 2,294 1,699 Other current liabilities 1,790 1,119 $ 13,847 $ 9,826 |
Loss Per Share of Common Shares
Loss Per Share of Common Shares | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Loss Per Share of Common Shares | 8. 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 shares 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 shares of 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 remained the same for both calculations due to the fact that when a net loss exists, dilutive shares are not included in the calculation. These potentially dilutive securities are more fully described in Note 11, Stockholders’ Equity and Additional Paid-in Capital. The following potentially dilutive securities outstanding at December 31, 2018 and 2017 have been excluded from the computation of diluted weighted average shares outstanding, as they would be antidilutive: 2018 2017 Warrants 2,618,824 2,618,824 Stock options and unvested stock awards 3,748,246 2,775,774 6,367,070 5,394,598 |
Long-Term Debt - Related Party
Long-Term Debt - Related Party | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Long-Term Debt - Related Party | 9. LONG-TERM DEBT – RELATED PARTY 2018 2017 Long-term debt, net of debt discount of $1,274 $ 14,027 $ 13,138 Less: current portion, net of debt discount of $100 1,100 1,600 $ 12,927 $ 11,538 On May 6, 2016, the Company through VBI DE assumed a term loan facility with Perceptive Credit Holdings, LP, a related party, (the “Lender”) in the amount of $6,000 (the “Facility”). On December 6, 2016, the Company amended the Facility (the “Amended Credit Facility”) and raised the Lender’s commitment amount to $13,200, which was combined with the remaining balance from the Facility of $1,800. On July 17, 2018, the Company amended the Amended Credit Facility (the “Second Amendment”) to extend the period the Company is required to pay only the interest on the loan from May 31, 2018 to December 31, 2018 and to extend the expiration date of certain warrants to purchase 363,771 common shares issued to the Lender with an original expiration date of July 25, 2019 to December 6, 2021. The Company accounted for this as a debt modification, and as a result of the extension of the warrant expiration date in connection with the Second Amended Facility, the debt discount was increased by $386. This amount represents the incremental fair value of the modified warrants. On January 31, 2019, the Company further amended the Amended Credit Facility (the “Third Amendment”) to i) extend the period the Company is required to pay only the interest on the loan from December 31, 2018 to the Amortization Commencement Date (which is defined as the later of July 31, 2019 and, if Sci-B-Vac Phase III clinical trial endpoints are achieved by June 30, 2019, January 31, 2020), ii) extend the maturity of the term loan to June 30, 2020 and iii) reduce the exercise price on certain warrants to purchase common shares issued to Perceptive Credit to $2.75 from $4.13 for 363,771 warrants issued on July 25, 2014 and for 363,771 warrants issued on December 6, 2016 and from $3.355 for 1,341,282 warrants issued on December 6, 2016. The Company will account for this as a debt modification, and as result of the amendment to the exercise price in connection with the Third Amended Facility, the debt discount will be increased by $179. This amount represents the incremental fair value of the modified warrants. The total principal amount of the loan under the Amended Credit Facility outstanding at December 31, 2018, including the $300 exit fee discussed below, is $15,300. The principal amount of the loan made under the Second Amendment 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 Company was required to only pay interest initially until May 31, 2018, which date was extended to December 31, 2018, pursuant to the Second Amendment and further extended to the Amortization Commencement Date pursuant to the Third Amendment. The interest rate as of December 31, 2018 was 13.3125%. Upon the occurrence of an event of default, and during the continuance of an event of default, the Applicable Margin, defined above, will be increased by 4.00% per annum. This term loan facility maturity date has been extended from December 6, 2019 to June 30, 2020 and includes both financial and non-financial covenants, including a minimum cash balance requirement. The Company was in compliance with these covenants as of December 31, 2018. Pursuant to the Amended Credit Facility, the Company agreed to appoint a representative of the lender on the Company’s board of directors (the “Board”) who was also a portfolio manager of the Company’s largest shareholder. Effective January 2018, the Lender’s representative resigned from our Board. The Company’s obligations under the Amended Credit Facility are secured on a senior basis by a lien on substantially all of the assets of the Company and its subsidiaries and are guaranteed by the Company and its subsidiaries. The Amended Credit Facility also contains customary events of default. The total debt discount of $3,839 is being charged to interest expense using the effective interest method over the term of the debt. As of December 31, 2018, and December 31, 2017, the unamortized debt discount is $1,274 and $2,163. Interest expense, net of interest income recorded for the year ended December 31, 2018 and 2017 was as follows after giving effect to the Third Amendment dated January 31, 2019 as discussed above: December 31 2018 2017 Interest expense – related party $ 1,980 $ 1,850 Amortization of debt discount – related party 1,274 1,181 Interest income (622 ) (149 ) Total interest expense, net of interest income $ 2,632 $ 2,882 The following table summarizes the future payments that the Company expects to make for long-term debt: Year ending December 31, 2019 $ 1,200 2020 14,100 $ 15,300 |
Employee Benefits
Employee Benefits | 12 Months Ended |
Dec. 31, 2018 | |
Retirement Benefits [Abstract] | |
Employee Benefits | 10. EMPLOYEE BENEFITS Defined contribution plan The Company operates a defined contribution retirement benefit plan for all qualifying employees in accordance with Israeli law. The assets of the plan are held separately from those of the Company in funds under the control of trustees. The total expense recognized for the years ended December 31, 2018 and 2017 was $218 and $190, respectively, and represents contributions payable to these plans by the Company at rates specified in the rules of the plan. For VBI DE and VBI Cda employees, the respective companies contribute up to 1.5% of the employee’s salary to a retirement benefit, which contribution is based on a 25% match of participating employee contributions. Such expense is not significant for any of the periods presented. Liability for severance pay Israel’s labor laws and the Law “severance pay, 1963” (the “Law”), require the Company to pay severance pay to employees during dismissal, disability and retirement. Legal retirement age now stands at 64 for women and 67 for men. Thus, under the plan, an employee who was employed by the Company for at least one year (and in the circumstances defined by the law) and was involuntarily terminated by the Company after the said period is entitled to severance pay. The rate of compensation listed in the law is the employee’s final monthly salary for each year of employment. Under the program, the Company is obligated to deposit amounts at the rate fixed by Law (since January 1, 2008), to ensure the accrual of such a severance pay due to the employee as described above. The rate required by law is 8.33% of the employee’s salary, which is deposited in a pension fund/insurance severance fund. Included in research and development expenses for the year ended December 31, 2018 is $24 of severance payments pursuant to the aforementioned statutory or contractual obligations. Included in research and development expenses and cost of revenues for the year ended December 31, 2017 is $187 and $50, respectively of severance payments pursuant to the aforementioned statutory or contractual obligations. |
Stockholders' Equity and Additi
Stockholders' Equity and Additional Paid-In Capital | 12 Months Ended |
Dec. 31, 2018 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity and Additional Paid-In Capital | 11. STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL Authorized Unlimited number of common shares without par value. Common shares issuances 2017 common share issuances i. On January 17, 2017 the Company issued 6,377 common shares related to stock options that were exercised during the year. ii. On March 22, 2017, the Company issued 23,250 stock awards pursuant to the 2016 Plan. Pursuant to Israeli tax requirements, the common shares were issued to a Trustee on behalf of SciVac employees. iii. On June 22, 2017, 25% of the stock awards granted on June 24, 2016 (see 2016 common share issuances ii above) vested and the Company issued 156,249 shares of the Company’s common shares. iv. During the first half of 2017, the Company issued 25,000 common shares of the Company to one consultant for services provided to the Company’s shareholders in connection with their respective consulting agreements. The fair value of the common shares of $85 was recognized as an expense. v. 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 for total gross proceeds of $71,905. In addition, in connection with the registered direct offering, the Company issued four-year warrants to purchase 550,000 common shares to an investor as a finder’s fee, at an exercise price of $3.34 per share. The Company incurred $4,683 of cash share issuance costs. vi. On December 18, 2017, the Company issued 274,000 common shares of the Company to Kevelt as part of a settlement agreement related to a Development and Manufacturing Agreement. The transaction was measured using the fair value of the Company’s common shares at November 8, 2017 at a price of $4.17 for a total of $1,142. 2018 common share issuances i. During the first half of 2018 the Company issued 39,828 common shares related to stock options that were exercised during the year. ii. On March 7, 2018, the Company issued 135,000 stock awards pursuant to the 2016 Plan. Pursuant to Israeli tax requirements, the common shares were issued to a Trustee on behalf of SciVac employees. iii. On June 18, 2018, 25% of the stock awards granted on June 24, 2016 vested and the Company issued 129,782 shares of the Company’s common shares. iv. On December 4, 2018, the Company issued 2,295,082 common shares of the Company to Brii Bio as part of a License Agreement (see Note 1). The transaction was measured using the fair value of the Company’s common shares at December 4, 2018 at a price of $1.58 for a total net proceeds of $3,626. v. On December 17, 2018, the Company closed an underwritten public offering of 30,665,304 common shares at a price of $1.40 per share for total gross proceeds of $42,932. The Company incurred $3,152 of share issuance costs of which $3,006 were paid in cash during the year ended December 31, 2018 and $146 are included in other current liabilities as at December 31, 2018. Stock option plans The Company’s stock option plans are approved by and administered by 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 The 2006 VBI US Stock Option Plan (the “2006 Plan”), was approved by and was previously administered by the VBI US board of directors which designated eligible participants to be included under the 2006 Plan, and designated the number of options, exercise price and vesting period of the new options. The 2006 Plan was not approved by the stockholders of VBI US. The 2006 Plan was superseded by the 2014 Plan (as defined below) following the PLCC Merger and no further options will be issued under the 2006 Plan. As at December 31, 2018, there were 1,140,053 options outstanding under the 2006 Plan. 2013 Stock Incentive Plan The 2013 Equity Incentive Plan (the “2013 Plan”) was approved by and was previously administered by the VBI DE board of directors which designated eligible participants to be included under the 2013 Plan, and designated the number of options, exercise price and vesting period of the new options. The 2013 Plan was approved by the VBI DE shareholders on November 8, 2013. No further options will be issued under the 2013 Plan. As at December 31, 2018, there were 3,460 options outstanding under the 2013 Plan. 2014 Equity Incentive Plan On May 1, 2014, the VBI DE board of directors adopted the VBI Vaccines Inc. 2014 Equity Incentive Plan (the “2014 Plan”). The 2014 Plan was approved by the VBI DE’s shareholders on July 14, 2014. No further options will be issued under the 2014 Plan. As at December 31, 2018, there were 613,577 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 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 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 December 31, 2018, there were 1,722,586 options outstanding and 268,570 RSUs unvested under the 2016 Plan. The principal features of the 2016 Plan are as follows: Eligible Participants Eligible participants include individuals employed (including services as a director) by the Company or its affiliates, including a service provider, who, by the nature of his or her position or job is, in the opinion of the Board, in a position to contribute to the success of the Company (“Eligible Persons”). Reservation of Shares The aggregate number of Common Shares reserved for issuance to any one participant under the 2016 VBI Equity Incentive Plan, together with all other security-based compensation arrangements must not exceed 5% of the total number of issued and outstanding Common Shares on a non-diluted basis. The maximum number of Common Shares (a) issued to insiders within any one year period; and (b) issuable to insiders at any time, under the 2016 VBI Equity Incentive Plan, when combined with all of the Company’s other security-based compensation arrangements, must not exceed 10% of the total number of issued and outstanding Common Shares. The aggregate number of common shares remaining available for issuance for awards under this plan total 5,213,166 at December 31, 2018. The source of common shares issued under the various stock option plans are new common shares. Options and Stock Appreciation Rights The Company may grant options to Eligible Persons on such terms and conditions consistent with the 2016 VBI Equity Incentive Plan. The exercise price for an option must not be less than 100% of the “market price,” as that term is defined in the 2016 Plan, based on the trading price per Common Share, on the date of grant of such option. With respect to Tandem Stock Appreciation Rights attached to an option, which allows the holder, upon vesting of the option and Tandem SAR, to choose to exercise the stock appreciation right or to exercise the option, the exercise price is the exercise price applicable to the option (as explained above) to which the Tandem SAR relates, subject to adjustment provisions under the 2016 VBI Equity Incentive Plan. For Stand-Alone SARs, a SAR that is granted without reference to any related Company options, the base price must not be less than 100% of the market price on the date of grant of such Stand-Alone SAR. Stock appreciation rights (and in the case of Tandem SARs, the related options) will be settled by payment in cash or Common Shares or a combination thereof, with an aggregate value equal to the product of (a) the excess of the market price on the date of exercise over the exercise price or base price under the applicable stock appreciation right, multiplied by (b) the number of stock appreciation rights exercised or settled. The Company has not issued any SARs under this plan at December 31, 2018 and 2017. Under the 2016 VBI Equity Incentive Plan unless otherwise designated by the Board of Directors, 25% of the options will vest on each of the first four anniversaries of the grant date. The term of options will be for a maximum of 10 years, unless exercised or terminated earlier in accordance with the terms of the 2016 VBI Equity Incentive Plan or the applicable grant agreement. Upon a participant’s termination of employment due to death, or in the case of disability: (a) the outstanding options that were granted prior to the year that includes the participant’s death or disability that have not become vested prior to such date will continue to vest and, upon vesting, be exercisable during the 36-month period following such date; and (b) the outstanding options that have become vested prior to the participant’s death or disability will continue to be exercisable during the 36-month period following such date. In the case of a participant’s termination of employment or contract for services without cause: (a) the outstanding options that have not become vested prior to the participant’s termination will continue to vest and, upon vesting, be exercisable during the 120-day period following such date; and (b) the outstanding options that have become vested prior to the participant’s termination will continue to be exercisable during the 120-day period following such date. In the case of a participant’s termination due to resignation (including voluntary withdrawal of services by a non-employee participant): (a) the outstanding options that have not become vested prior to the date of notice of resignation will be forfeited and cancelled as of such date; and (b) the outstanding options that have become vested prior to the date of notice of resignation will continue to be exercisable during the 90-day period following such date. In the case of a participant’s termination of employment or contract for services for cause, any and all then outstanding unvested options granted to such participant will be immediately forfeited and cancelled, without any consideration therefor, as of the date such notice of termination is given. Share Units The Board of Directors may grant share units, which include RSUs and PSUs, to Eligible Persons on such terms and conditions consistent with the 2016 VBI Equity Incentive Plan. The Board will determine the grant value and the valuation date for each grant of share units. The number of share units to be covered by each grant will be determined by dividing the grant value for such grant by the market value of a Common Share as at the valuation date, rounded up to the next whole number. Share units subject to a grant will vest as specified in the grant agreement governing such grant, provided that the participant is employed on the relevant vesting date. RSUs and PSUs will be settled upon, or as soon as reasonably practicable following the vesting thereof, subject to the terms of the grant agreement. In all events, RSUs and PSUs will be settled on or before the earlier of the 90th day following the vesting date and the date that is 2 ½ months after the end of the year in which the vesting occurred. Settlement will be made by way of issuance of one Common Share for each RSU or PSU, a cash payment equal to the market value of the RSUs or PSUs being settled, or a combination thereof. If the share units would be settled within a blackout period, such settlement will be postponed until the earlier of the 6th trading day following the end of such blackout period and the otherwise applicable date of settlement as determined in accordance with the settlement provision set out above. The Company has not issued any PSUs under this plan at December 31, 2018 and 2017. All RSUs issued under the plan at December 31, 2018 and 2017 contain no cash settlement provision. If and when cash dividends are paid with respect to Common Shares to shareholders of record during the period from the grant date to the date of settlement of the RSUs or PSUs, a number of dividend equivalent RSUs or PSUs, as applicable, will be credited to the share unit account of such participant. In the event a participant’s employment is terminated due to resignation, share units that have not vested prior to the date of resignation will not vest and all such Common Shares will be forfeited immediately. In the case of a participant’s termination due to death, or in the case of disability, all share units granted prior to the year that includes the participant’s death or disability, that have not vested prior to the participant’s death or disability will vest at the end of the vesting period and in the case of PSUs, subject to the achievement of applicable performance conditions and the adjustment of the number of PSUs that vest to reflect the extent to which such performance conditions were achieved. In the event a participant’s employment or contract for services is terminated without cause, prior to the end of a vesting period relating to such participant’s grant, the number of RSUs or PSUs, respectively, as determined by their respective formula set out in the 2016 VBI Equity Incentive Plan will become vested at the end of the vesting period. In the event a participant’s employment is terminated for cause, share units that have not vested prior to the date of the termination for cause will not vest and all such share units will be forfeited immediately. Restricted Stock Restricted stock means Common Shares that are subject to restrictions on such participant’s free enjoyment of the Common Shares granted, as determined by the Board of Directors. Notwithstanding the restrictions, the participant will receive dividends paid on the restricted stock, will receive proceeds of the restricted stock in the event of any change in the Common Shares and will be entitled to vote the restricted stock during the restriction period. The participant will not have rights to sell, transfer or assign, or otherwise dispose of the shares of restricted stock or any interest therein while the restrictions remain in effect. Grants of restricted stock will be forfeited if the applicable restriction does not lapse prior to such date or occurrence of such event or the satisfaction of such other criteria as is specified in the grant agreement. No restricted stock has been issued through December 31, 2018. Stock-based compensation expense The table below provides information, as of December 31, 2018, regarding the 2006 Plan, the 2013 Plan, the 2014 Plan and the 2016 Plan under which our equity securities are authorized for issuance to officers, directors, employees, consultants, independent contractors and advisors. Plan Category Number of securities to be issued upon exercise of outstanding awards Weighted average exercise price 2006 Plan 1,140,053 $ 4.09 2013 Plan 3,460 $ 7.31 2014 Plan 613,577 $ 5.23 2016 Plan 1,991,156 $ 3.82 Total 3,748,246 $ 4.14 Activity related to stock options is as follows: Number of Stock Options Weighted Average Exercise Price Balance outstanding at December 31, 2016 2,167,903 $ 4.45 Granted 303,500 $ 3.72 Exercised (6,377 ) $ 2.50 Forfeited (113,631 ) $ 4.37 Balance outstanding at December 31, 2017 2,351,395 $ 4.44 Granted 1,515,000 $ 3.82 Exercised (39,828 ) $ 2.50 Forfeited (346,891 ) $ 4.47 Balance outstanding at December 31, 2018 3,479,676 $ 4.14 Exercisable at December 31, 2018 2,292,112 $ 4.34 Outstanding Exercisable Exercise Price Number Of Options Weighted Average Remaining Contractual Life (Years) Number Of Options Weighted Average Exercise Price $ 0.00 - $ 3.49 508,493 7.47 212,651 $ 2.87 $ 3.50 - $ 4.49 2,211,920 7.60 1,380,852 $ 4.15 $ 4.50 - $ 5.50 691,299 5.37 630,645 $ 4.91 $ 5.50+ 67,964 5.51 67,964 $ 8.13 3,479,676 7.10 2,292,112 $ 4.34 The weighted average remaining contractual life of exercisable options was 6.12 years and 5.57 years at December 31, 2018 and 2017, respectively. Information relating to restricted stock units is as follow: Number of Stock Awards Weighted Avg Fair Value at Grant Date Unvested shares outstanding at January 1, 2016 and December 31, 2016 639,374 3.88 Granted 57,000 $ 4.72 Vested (213,870 ) $ 3.93 Forfeited (58,125 ) $ 3.89 Unvested shares outstanding at December 31, 2017 424,379 $ 3.99 Granted 150,000 $ 4.26 Vested (237,669 ) $ 4.01 Forfeited (68,140 ) $ 3.89 Unvested shares outstanding at December 31, 2018 268,570 $ 4.13 The intrinsic value of outstanding options at December 31, 2018 was $0 (the intrinsic value of vested options was $0 and the intrinsic value of those expected to vest was $0). The fair value of the vested RSU’s was $954 for the year ended December 31, 2018. The intrinsic value of exercised options was not significant for the years ended December 31, 2018 and 2017. In determining the amount of stock-based compensation the Company used the Black-Scholes option pricing model to establish the fair value of options granted by applying the following weighted average assumptions: 2018 2017 Volatility 114.68 % 87.22 % Risk free interest rate 2.57 % 2.31 % Expected term in years 5.84 6.3 Expected dividend yield 0.00 % 0.00 % Weighted average fair value per option $ 3.21 $ 3.12 The volatility was based on an average of volatility rates of a pool of public pharmaceutical or biotechnology companies that are at a comparable stage of development and the Company’s recent historic volatility, all calculated taking into account the expected term of the option. The risk-free rate was based on rates provided by the United States Treasury with a term equal to the expected life of the option. The Company does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate expected term due to the limited period of time its equity shares have been publicly traded. As a result, the Company uses the simplified method to determine the expected term of stock options whereby the expected term equals the average between the vesting period and the contractual life. The fair value of the options is recognized as an expense on a straight-line basis over the vesting period, forfeitures are accounted for when they occur. The total stock-based compensation expense recorded in the years ended December 31, was as follows: 2018 2017 Research and development $ 696 $ 702 General and administration 2,556 1,648 Cost of revenue 60 60 Total stock-based compensation expense $ 3,312 $ 2,410 There is $3,935 of unrecognized compensation from all equity awards as at December 31, 2018. This expense will be recognized over a weighted average period of 1.96 years. The number of restricted stock awards vested during the year ended December 31, 2018 includes 9,281 shares withheld or repurchased by the Company on behalf of employees to satisfy $35 of tax obligations relating to the vesting of such shares. Warrants The Company amended a portion of the warrants issued on December 6, 2016, as described in Note 9. The warrants issued on October 30, 2017, as a finder’s fee in connection with the registered direct offering described earlier in Note 11, entitle the holder to purchase 550,000 common shares at an exercise price of $3.34 per share. The warrants are exercisable at any time on or prior to the fourth anniversary of their issue date. The fair value of the warrants issued on October 30, 2017 in the amount of $611 was based on the Black-Scholes option pricing model. Activity related to the warrants is as follows: Number of Warrants Weighted Average Exercise Price Balance outstanding at December 31, 2016 2,068,824 $ 3.63 Issued 550,000 $ 3.34 Balance outstanding at December 31, 2017 and 2018 2,618,824 $ 3.57 |
Revenue and Deferred revenue
Revenue and Deferred revenue | 12 Months Ended |
Dec. 31, 2018 | |
Revenue from Contract with Customer [Abstract] | |
Revenue and Deferred revenue | 12. REVENUE AND DEFERRED REVENUE Revenue is comprised of the following: 2018 2017 License revenue $ 2,637 $ - Product revenue 604 502 R&D Service revenue 114 363 $ 3,355 $ 865 The following table presents revenue expected to be recognized in the future related to performance obligations, based on current estimates, that are unsatisfied at December 31, 2018: Total 2019 2020 and thereafter Product revenue 469 - 469 R&D Service revenue 4,703 2,375 2,328 Total $ 5,172 $ 2,375 $ 2,797 The following table presents changes in the deferred revenue balance for the year ended December 31, 2018: Balance at December 31, 2017 $ 669 Amounts received in 2018 4,815 Recognition of deferred revenue (74 ) Currency translation (238 ) Balance at December 31, 2018 5,172 Short Term 2,375 Long Term 2,797 Collaboration and License Agreement – Brii Bio On December 4, 2018, we entered into a License Agreement with Brii Bio, whereby: ● the Company and Brii Bio agreed to collaborate on the development of a hepatitis B recombinant protein-based immunotherapeutic in the licensed territory, which consists of China, Hong Kong, Taiwan and Macau (collectively, the “Licensed Territory”), and to conduct a Phase II collaboration clinical trial for the purpose of comparing VBI-2601, which is a recombinant protein-based immunotherapeutic developed by VBI for use in treating chronic hepatitis B, with a novel composition developed jointly with Brii Bio (either being the “Licensed Product”); and ● The Company granted Brii Bio an exclusive royalty-bearing license to perform studies, and regulatory and other activities, as may be required to obtain and maintain marketing approval of the Licensed Product, for the treatment of hepatitis B in the Licensed Territory and to commercialize and the Licensed Product for the diagnosis and treatment of chronic hepatitis B in the Licensed Territory Pursuant to the Collaboration and License Agreement, the Company is responsible for the R&D Services and Brii Bio is responsible for costs relating to the clinical trials for the Licensed Territory. The initial consideration of the Collaboration and License Agreement consisted of a $11 million non-refundable upfront payment. As part of Collaboration and Licences Agreement, the Company and Brii Bio entered into a stock purchase agreement. Under the terms of the stock purchase agreement, the Company issued to Brii Bio 2,295,082 shares of its common stock valued at $3.6 million (based on the Company’s common stock price on December 4, 2018). See Note 11. The remaining $7.4 million, deemed to be the initial transaction price, was allocated to two performance obligations: i) the VBI-2601 license and ii) R&D services. The R&D services were allocated $4.8 million of the transaction price using an estimated selling price based on a expected cost plus a margin approach and the remaining transaction price of $2.6 million was allocated to the VBI-2601 license using the residual method. In addition, the Company is also eligible to receive an additional $117.5 million in potential regulatory and sales milestone payments, along with royalties on commercial sales in the licensed territory. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. Therefore, no variable consideration was included in the initial transaction price and no such amounts have been recognized to date. On December 4, 2018, the Company recognized the VBI-2601 license when it was transferred and Brii Bio is able to use and benefit from the license, as it was determined to be distinct. The R&D Services will be satisfied over time as services are rendered using the “cost-to-cost” input method as this method represents the most accurate depiction of the transfer of services based on the types of costs expected to be incurred. Upon termination of the License Agreement prior to the end of the term, there is no obligation for refund and any amounts in deferred revenue related to unsatisfied performance obligations will be immediately recognized. Prior to us entering into the License Agreement, the Company paid $6 million to terminate a distribution agreement with a third party who previously held certain distribution rights to certain Asian markets. This amount is included in general and administrative expenses for the year ended December 31, 2018. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 13. INCOME TAXES Components of the Company’s loss from continuing operations before income taxes are as follows: 2018 2017 United States $ (4,757) $ (7,220 ) Canada (8,177) (10,568 ) Israel (50,666) (21,638 ) Total $ (63,600) $ (39,426 ) The components of the income tax (provision) benefits are as follows: 2018 2017 Current Tax Canada $ - $ 3 - 3 Deferred Tax Canada - 428 - 428 Total Canada - 431 $ - $ 431 The Company operates in United States, 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. A reconciliation of the income tax rate with the Company’s effective tax rate and income tax provisions are as follows: 2018 2017 Loss before income taxes $ (63,600 ) $ (39,425 ) Canadian statutory tax rate 26.50 % 26 % Expected recovery of income tax 16,854 10,251 Research and development tax credits 256 227 Change in valuation allowance (14,685 ) (5,496 ) Difference between Canadian and foreign tax rates (1,708 ) 1,011 Other (125 ) 706 Change in tax rates 59 (5,749 Stock based compensation (651 ) (519 ) Income tax benefit $ - $ 431 The income tax benefit for the year ended December 31, 2017 related to the deferred tax assets recorded for the increase in net operating loss carry forwards. For 2018 the Canadian statutory income tax rate of approximately 26.5% is comprised of federal income tax at approximately 15% and provincial income tax at approximately 11.5%. The Israel statuary income rate is approximately 23%. For 2017, the Canadian statutory income tax rate of approximately 26% is comprised of federal income tax at approximately 15% and provincial income tax at approximately 11%. The Israel statuary income rate is approximately 25%. On December 22, 2017, the United States enacted tax reform legislation through the Tax Cuts and Jobs Act, which significantly changes the existing U.S. tax laws, including a reduction in the corporate tax rate from 35% to 21%, a move from a worldwide tax system to a semi-territorial system, a change in the treatment of operating loss carryforwards generated subsequent to 2017 fiscal year as well as other changes. As a result of enactment of the legislation, the Company recorded a one-time change to its deferred tax assets and related valuation allowance. As the Company has a full valuation allowance such change did not impact the Company’s results of operations or financial position. The deferred tax asset (liability) consists of the following: 2018 2017 Deferred tax assets (liabilities): Net operating losses $ 41,556 $ 31,858 Research and development tax credits 13 350 10,550 Property and equipment 435 581 Reserves and other 1,457 1,250 Interest 858 - Intangible assets (15,546) (16,814 ) Net deferred tax assets 42,110 27,425 Less: valuation allowance (42,110 ) (27,425 ) Net deferred tax assets (liabilities) $ - $ - As of December 31, 2018, and 2017, the Company has United States federal net operating loss carryovers (“NOLs”) of approximately $39 million and $35.3 million, respectively, including $29 million related to the acquisition of VBI DE, available to offset taxable income which expire beginning in 2026. The NOL’s related to the acquisition of VBI DE may be subject to limitations under Internal Revenue Code Section 382 and similar state income tax provisions should there be a greater than 50% ownership change as determined under the regulations. The Company plans on undertaking a detailed analysis of any historical and/or current Section 382 ownership changes that may limit the utilization of the net operating loss carryovers. As of December 31, 2018, and 2017, the Company also has Canadian net operating loss carryovers of approximately $47 million and $44.9 million, respectively available to offset future taxable income which expire beginning in 2024. As at December 31, 2018 the Company also has Israel net operating loss carryovers of approximately $80.3 million (2017 - $44.9 million) respectively, which can be carried forward indefinitely. At December 31, 2018 and 2017, the Company has $4.9 million and $5.0 million, respectively, of investment tax credits available to carry forward and reduce future years’ Canadian income taxes which expire beginning in 2026. As of December 31, 2018, and 2017, the Company has unclaimed research and development expenses in Canada of approximately $17.2 million and $17.0 million, respectively, which are available to offset future taxable income indefinitely. At December 31, 2018, the Company had NOL’s aggregating approximately $166.1 million. The NOL’s are available to reduce taxable income of future years expire as follows: United States Canada Israel Total 2024 $ - $ 444 $ - $ 444 2025 - 1,382 - 1,382 2026 10 3,486 - 3,496 2027 446 4,040 - 4,486 2028 718 1,564 - 2,282 2029 672 2,929 - 3,601 2030 2,556 948 - 3,504 2031 3,617 1,173 - 4,790 2032 2,962 - - 2,962 2033 3,126 1,370 - 4,496 2034 5,626 5,131 - 10,757 2035 4,661 1,543 - 6,204 2036 5,323 8,191 - 13,514 2037 6,017 9,204 - 15,221 2038 - 5,432 5,432 No expiration 3,312 - 80,265 83,577 Total losses $ 39,046 $ 46,837 $ 80,265 $ 166,148 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 14. Commitments and Licensing (a) In connection with the acquisition of the ePixis technology in 2011, VBI Cda also agreed to make certain contingent payments as follows: Upon the completion of a “Successful Technology Transfer”, as defined in the Sale and Purchase Agreement (“SPA”), to a contract manufacturing organization, VBI Cda paid €102 (approximately $110 and referred to as the “Transfer Payment”) to the Sellers during the second quarter of 2015. The Transfer Payment related to the achievement of the first milestone, which occurred during the three months ended June 30, 2015. The Company is committed to make further contingent payments pursuant to defined milestones in the SPA depending on whether there continue to exist any issued and valid claims on the acquired patents. Contingent payments include: ● Upon first approval in the United States or the European Union: €500 to €1,000; ● Upon commercialization when cumulative net sales equals or exceeds: ○ €25,000: €750 to €1,500; and, ○ €50,000: €1,000 to €2,000; ● Upon commercialization by one or more sublicenses when cumulative net sales equals or exceeds: ○ €25,000: €375 to €750; ○ €50,000: €375 to €750; ○ €75,000: €500 to €1,000; ○ €100,000: €500 to €1,000, ○ VBI will be obligated to pay to the Sellers the balance still owing on the total €3,500 when either cumulative net sales of €50,000 by VBI or €100,000 by VBI and its sublicenses is achieved. The Company is further committed to pay all costs of protecting the patents and make contingent payments to the licensor of the acquired patents pursuant to defined milestones in an amendment to the related license agreement which include: royalty fees ranging between 0.75% and 1.75% depending on the level of net sales; and, lump sum payments ranging from €50 to €1,000 depending on the stage of clinical development and ultimately commercial approval. Additionally, 5% to 25% of any sublicensing fees depending on stage of clinical development are also payable to the licensor. Except for the Transfer Payment, which became due upon successful technology transfer to a contract manufacturing organization, the events obliging the Company to make these payments to the Sellers have not yet occurred and are not probable of occurring; consequently, no amounts are accrued in respect of these contingencies. (b) 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 of $42 and $35 were recorded in cost of revenues for the years ended December 31, 2018 and 2017, respectively. In addition, the Company is committed to pay 30% of any and all non-royalty consideration, in any form, received by Company from sub-licensees (other than consideration based on net sales for which a royalty is due under the License Agreement), provided that the payment of 30% shall not apply to a grant of rights in or relating to: (i) the territory “(Territory”)as such term was defined prior to an amendment dated January 24, 2005; or (ii) the Berna Territory (as defined in therein). We are to pay Ferring the above-mentioned royalties on a country-by-country basis until the date which is 10 years after the date of commencement of the first royalty year in respect of such country Until the 30 th (c) 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 of $30 and $25 were recorded in cost of revenues for the years ended December 31, 2018 and 2017 respectively. Legal Proceedings From time to time, the Company may be involved in certain claims and litigation arising out of the ordinary course and conduct 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. On September 13, 2018, two actions were brought in the District Court of the central district in Israel naming our subsidiary SciVac as a defendant. In one claim, two minors, through their parents, allege among other things, defects in certain batches of Sci-B-Vac discovered in July 2015; that Sci-B-Vac was approved for use in children and infants in Israel without sufficient evidence establishing its safety; that SciVac failed to provide accurate information about Sci-B-Vac to consumers and that each child suffered side effects from the vaccine. The claim was filed together with a motion seeking approval of a class action on behalf of 428,000 children vaccinated with Sci-B-Vac in Israel from April, 2011 and seeking damages in a total amount of NIS 1,879,500,000 (not in thousands) ($501,467). The second claim is a civil action brought by two minors and their parents against SciVac and the Israel Ministry of Health alleging, among other things, that SciVac marketed an experimental, defective, hazardous or harmful vaccine; that Sci-B-Vac was marketed in Israel without sufficient evidence establishing its safety; and that Sci-B-Vac was produced and marketed in Israel without approval of a western regulatory body. The claim seeks damages for past and future losses and expenses as well as punitive damages. SciVac believes these matters to be without merit and intends to oppose the motion and otherwise defend these claims vigorously. |
Operating Leases
Operating Leases | 12 Months Ended |
Dec. 31, 2018 | |
Leases [Abstract] | |
Operating Leases | 15. OPERATING LEASES The Company has entered into various non-cancellable lease agreements for its office, lab and manufacturing facilities. These arrangements expire at various times through 2022. Rent expense for the years ended December 31, 2018 and 2017 was $992 and $919, respectively, and is included in general and administration in the statement of operations and comprehensive loss. The future annual minimum payments under these leases is as follows: Year ending December 31 2019 $ 902 2020 503 2021 427 2022 36 Total $ 1,868 On January 15, 2019, the Company entered into a 3 year non-cancelable lease agreement for its office at SciVac for $85 a year. |
Segment Information
Segment Information | 12 Months Ended |
Dec. 31, 2018 | |
Segment Reporting [Abstract] | |
Segment Information | 16. SEGMENT INFORMATION The Company’s Chief Executive Officer (“CEO”) has been identified as the chief operating decision maker. The CEO evaluates the performance of the Company and allocates resources based on the information provided by the Company’s internal management system at a consolidated level. The Company has determined that it has only one operating segment. Revenues from external customers are attributed to geographic areas based on location of the contracting customers. 2018 2017 Revenue in Israel $ 435 $ 520 Revenue in China/Hong Kong 2,667 151 Revenue in Europe 253 194 Total $ 3,355 $ 865 There was no revenue attributed to our country of domicile, Canada, for years ended December 31, 2018 and 2017. For the year ended December 31, 2018, the Company had 1 customer that individually accounted for 79% of revenues. For the year ended December 2017, the Company had 5 customers that individually accounted for 25%, 17%, 17%, 12% and 11% of revenues, respectively. Tangible Long Lived Assets (Property and equipment) attributed to geographic areas are as follows: 2018 2017 Property and equipment in Israel $ 8,396 $ 2,116 Property and equipment in United States 52 - Property and equipment Canada (country of domicile) 77 129 Total $ 8,525 $ 2,245 |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 17. RELATED PARTY TRANSACTIONS 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. For the years ended December 31, 2018 and 2017 revenue recognized amounted to $0 and $4, respectively. Effective October 17, 2018, OPKO Bio is no longer a related party. See Note 9 for the Company’s long term debt with a lender that is affiliated with the Company’s largest shareholder and is a related party. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events | 18. SUBSEQUENT EVENTS On January 31, 2019, the Company approved to grant 3,900,000 stock options and awards to existing employees, directors and an eligible service provider pursuant to the 2016 Plan. 3,710,000 of the granted options and awards vest on a monthly basis over 36 months and automatically expire on January 31, 2029 while 190,000 awards vest immediately. On January 31, 2019, the Company entered into the Third Amendment to the Amended Credit Facility, see Note 9 for more further discussion. On January 15, 2019, the Company entered into a 3 year non-cancelable lease agreement for its office at SciVac, see Note 15 for further discussion. On January 29, 2019 we incorporated SciVac Hong Kong Limited. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of Consolidation | Basis of Consolidation The consolidated financial statements include the accounts of VBI and its wholly owned subsidiaries, SciVac, VBI DE, VBI US and VBI Cda. Intercompany balances and transactions between the Company and its subsidiaries are eliminated in the consolidated financial statements. |
Foreign Currency | Foreign currency The functional and reporting currency of the Company is the United States dollar. Each of the Company’s subsidiaries determines its own respective functional currency, based on the primary economic environment that it operates in, 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 other comprehensive loss /income. Foreign exchange gains and losses arising from transactions denominated in a currency other than the functional currency of the entity involved, are included in operating results. |
Use of Estimates | Use of Estimates Preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (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 consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual amounts could differ from the estimates made. We continually evaluate estimates used in the preparation of the 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 revenue recognition, determining the deferred tax valuation allowance, estimating accrued clinical expenses, the inputs in determining the fair value of the in-process research and development (“IPR&D”) and goodwill as part of the annual impairment analysis and the inputs in determining the fair value of equity-based awards and warrants issued. Actual results may differ from those estimates. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject us to significant concentrations of credit risk consist principally of cash and accounts receivable. We place our cash primarily in commercial checking accounts. Commercial bank balances may from time to time exceed federal insurance limits. However, the Company believes credit risk is low as the cash resides in large highly rated financial institutions. The Company has not experienced any losses in cash and accounts receivable for years ended December 31, 2018 and 2017, respectively. |
Inventory | Inventory Inventory components include all raw materials, work-in-progress and finished goods. Cost is determined on a first-in, first-out basis. Inventory is valued at the lower of cost or net realizable value. The cost of inventories comprises costs to purchase and costs incurred in bringing the inventories to their present location and condition. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. On an annual basis, the Company evaluates the condition and age of inventories and makes provisions for slow moving inventories accordingly. |
Deferred Financing Costs | Deferred financing costs Offering costs related to debt and equity financing consist of direct incremental external expenses. The Company presents debt issuance costs related to a recognized long-term debt in the consolidated balance sheet as a direct deduction of the carrying value of the long-term debt, consistent with the accounting treatment of debt discounts. The amortization of debt issuance costs follows the effective interest rate method. Offering costs related to registration statements and the initiation of the Distribution Agreement are recorded as an asset and are reclassified to equity upon the successful selling of common shares. The costs are reviewed for impairment and will be recorded to expense if and when the Company determines that future equity offerings are not probable of occurring. At December 31, 2018 and 2017, the Company had $154 and $240 of deferred offering costs, respectively, recorded as an other current asset. |
Property and Equipment | Property and equipment Property and equipment are recorded at cost less accumulated depreciation. The assets are depreciated by the straight-line method, over the estimated useful lives of the related assets as follows. Number of years Furniture and office equipment 5-14 Machinery and equipment 3-7 Computers 2-3 Leasehold improvements shorter of useful life or the term of the lease When assets are retired or otherwise disposed of, the cost and the related accumulated depreciation is removed from the accounts, and any resulting gain or loss is recognized in the consolidated statement of operations and comprehensive loss. The cost of maintenance and repairs is charged to expense as incurred; significant renewals and betterments are capitalized. |
Impairment of Long-lived Assets | Impairment of long-lived assets Long-lived assets, such as property and equipment and finite-lived intangible assets, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. Recoverability of assets to be held and used is measured by comparison of the carrying amount of an asset to the estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of the asset exceeds its estimated future cash flows, then an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the asset. The Company recorded an impairment of $278 during the year ended December 31, 2018 related to certain leasehold improvements and manufacturing equipment no longer being utilized in the business as a result of the modernization and capacity increase of our manufacturing facility. The amount represented the remaining net book value of these assets. The impairment is included in general and administrative on the consolidated statements of operations and comprehensive loss. |
Goodwill and In-Process Research and Development ("IPR&D") Assets | Goodwill and In-Process Research and Development (“IPR&D”) Assets The Company’s intangible assets determined to have indefinite useful lives including IPR&D and goodwill, are tested for impairment annually, or more frequently if events or circumstances indicate that the assets might be impaired. Such circumstances could include but are 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. 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. 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. Subsequently (if necessary after step zero), if the carrying value of a reporting unit exceeded its fair value an impairment would be recorded. We would perform our goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. The Company has established August 31st as the date for its annual impairment test of goodwill. There was no goodwill impairment determined as a result of the Company’s annual testing on August 31, 2018. The fair value of the Company, which consists of a single reporting unit, included in the impairment test was determined using the closing market stock price of VBI as of August 31, 2018. The goodwill is in VBI Cda and the change in carrying value from December 31, 2017 relates to currency translation adjustments which decreased goodwill by $709 for the year ended December 31, 2018. The change in carrying value from December 31, 2016 to December 31, 2017 relates to currency translation adjustments which increased goodwill by $589. 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. There was no IPR&D impairment determined as a result of the Company’s annual testing on August 31, 2018. The fair value of the IPR&D assets included in the impairment test on August 31, 2018 was determined using the income approach method and is considered Level 3 in the fair value hierarchy. Some of the more significant estimates and assumptions inherent in the estimate of the fair value of IPR&D assets include the amount and timing of costs to develop the IPR&D into viable products, the amount and timing of future cash inflows, the discount rate and the probability of technical and regulatory success applied to the cash flows. The discount rate used was 13.5% and the cumulative probability of technical and regulatory success to achieve approval to market the products ranged from approximately 6% to 25%. The IPR&D assets are in VBI Cda and the change in carrying value from December 31, 2017 relates to currency translation adjustments which decreased IPR&D assets by $4,976 for the year ended December 31, 2018. The change in carrying value from December 31, 2016 to December 31, 2017 relates to currency translation adjustments which increased IPR&D assets by $4,131. |
Other Intangible Assets | Other Intangible Assets The Company’s other intangible assets include patents with finite lives. These assets obtained are recorded at cost less accumulated amortization and any impairment losses. The Company amortizes intangible assets with finite lives on a straight-line basis over their estimated useful lives. |
Long Term Debt | Long Term Debt The Company accounts for amendments to long-term debt as a substantial modification if the present value of the cash flows under the terms of the new debt instrument is at least 10 percent different from the present value of the remaining cash flows under the terms of the original instrument. A substantial modification shall be accounted for like an extinguishment. If the cash flow effect on a present value basis is less than 10%, the debt instruments are accounted for as a debt modification. |
Research and Development | Research and development All costs of research and development are expensed as incurred. When preparing our financial statements, we are required to estimate our accrued clinical expenses. This process involves reviewing contracts and communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual cost. Payments under some of the contracts we have with third parties depend on factors, such as successful enrollment of certain numbers of patients, site initiation and the completion of clinical trial milestones. When accruing clinical expenses, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If possible, we obtain information regarding unbilled services directly from our service providers. However, we may be required to estimate the cost of these services based only on information available to us. If we underestimate or overestimate the cost associated with a trial or service at a given point in time, adjustments to research and development expenses may be necessary in future periods. Historically, our estimated accrued clinical expenses have approximated actual expense incurred. |
Revenue Recognition | Revenue recognition Effective January 1, 2018, we adopted Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers (Topic 606) (“Topic 606”) using the modified retrospective method which consisted of applying and recognizing the cumulative effect of Topic 606 at the date of initial application. Topic 606 supersedes the revenue recognition requirements in Accounting Standards Codification (“ASC”) Topic 605, Revenue Recognition (“Topic 605”). There was no material impact on adoption to our consolidated financial statements related to the adoption of ASC 606. We recognize revenue when we transfer promised goods or services to customers in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenue when (or as) we satisfy the performance obligation(s). At contract inception, we assess the goods or services promised within each contract, assess whether each promised good or service is distinct and identify those that are performance obligations. The Company must use significant judgment to determine: a) the number of performance obligations based on the determination under step (ii) above and whether those performance obligations are distinct from other performance obligations in the contract; b) the transaction price under step (iii) above; and c) the stand-alone selling price for each performance obligation identified in the contract for the allocation of transaction price in step (iv) above. The Company uses judgment to determine whether milestones or other variable consideration, except for royalties, should be included in the transaction price. The transaction price is allocated to each performance obligation on an estimated stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. Where a portion of non-refundable up-front fees or other payments received are allocated to continuing performance obligations under the terms of a collaborative arrangement, they are recorded as contract liabilities and recognized as revenue when (or as) the underlying performance obligation is satisfied. Product sales The Company recognizes revenue from product sales when obligations under the terms of the contract with the customer are satisfied; this occurs with the transfer of control of the goods to the customers. Collaborative Arrangements We enter into collaborative arrangements, which are within the scope of ASC 606, with partners that typically include payment to us of one of more of the following: (i) license fees; (ii) research and development services to be performed as part of the contract (“R&D services”) (iii) payments related to the achievement of developmental, regulatory, or commercial milestones; and (iv) royalties on net sales of licensed products. The Company first evaluates license and/or collaboration arrangements to determine whether the arrangement (or part of the arrangement) represents a collaborative arrangement pursuant to ASC Topic 808, Collaborative Arrangements, based on the risks and rewards and activities of the parties pursuant to the contractual arrangement. The Company accounts for collaborative arrangements (or elements within the contract that are deemed part of a collaborative arrangement), which represent a collaborative relationship and not a customer relationship, outside the scope of ASC 606. The Company’s collaborations primarily represent revenue arrangements. License fees If a license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. R&D Services The promises under the Company’s collaboration and license agreements generally include research and development services to be performed by the Company. For performance obligations that include research and development services, the Company generally recognizes revenue allocated to such performance obligations based on an appropriate measure of progress. The Company utilizes judgment to determine the appropriate method of measuring progress for purposes of recognizing revenue, which is generally an input measure such as costs incurred. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Royalties For arrangements that include sales-based royalties, including milestone payments based on a level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from any of its licensing arrangements. |
Employee Benefits | Employee benefits The Company operates a defined contribution retirement benefit plan for all qualifying employees in accordance with Israeli law. The assets of the plan are held separately from those of the Company in funds under the control of trustees. The Company’s liability for severance pay for the employees of its subsidiary in Israel is calculated in accordance with Israeli law based on the most recent salary paid to employees and the length of employment in the Company. The Company records its obligation with respect to employee severance payments as if it were payable at each balance sheet date. Obligations for employee benefits are recognized as a component of operating expenses in the statement of operations and comprehensive loss in the periods during which services are rendered by employees. The Company records its obligation with respect to employee severance payments as if it was payable at each balance sheet date. |
Income Taxes | Income taxes Deferred tax assets and liabilities are determined based on the differences between the financial reporting and tax basis of assets and liabilities using enacted tax rates which will be in effect when the differences reverse. The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax asset will be realized. The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities based on the technical merits of the position. The benefit is measured as the largest amount that is more likely than not to be realized upon ultimate settlement. The Company does not have any uncertain tax positions or accrued penalties and interest as at December 31, 2018 and 2017. If such matters were to arise, the Company would recognize interest and penalties related to income tax matters in income tax expense. The Company’s claim for Scientific Research and Experimental Development (SR&ED) deductions for income tax purposes are based upon management’s interpretation of the applicable legislation in the Income Tax Act (Canada). These amounts are subject to review and acceptance by the Canada Revenue Agency and may be subject to adjustment. |
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. 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 consolidated balance sheet consist of cash, accounts receivable, other current assets, accounts payable and other current liabilities. The Company believes that the carrying value of its current 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 long-term financial assets approximate their respective fair values. The fair value of our outstanding debt, including the current portion, is estimated to be approximately $14,975 and $15,157 at December 31, 2018 and 2017, respectively. The fair value of the outstanding debt is considered to be Level 3 in the fair value hierarchy and was estimated by discounting to present value the scheduled coupon payments and principal repayment, using an appropriate fair market yield. |
Loss Per Share | Loss per share Basic loss per share is computed by dividing net loss by the weighted average number of shares outstanding during the period. Diluted loss per share is computed by dividing net loss by the weighted average number of shares outstanding and the impact of all dilutive potential shares. There is no dilutive effect on the earnings per share for all periods presented. |
Operating Leases | Operating leases Operating lease payments are recognized as an expense on a straight-line basis over the lease term. Contingent rentals arising under operating leases are recognized as an expense in the period in which they are incurred. |
Stock-based Compensation | Stock-based compensation The Company accounts for share-based awards to employees and directors in accordance with the provisions of ASC 718, Compensation—Stock Compensation. Under ASC 718, share-based awards are valued at fair value on the date of grant and that fair value is recognized over the requisite service period. The Company values its stock options using the Black-Scholes option pricing model. The Company accounts for forfeitures when they occur. The Company accounts for share-based payments to non-employees issued in exchange for services based upon the fair value of the equity instruments issued. Compensation expense for stock options issued to non-employees is calculated using the Black-Scholes option pricing model and is recorded over the service performance period. Options subject to vesting are required to be periodically remeasured over their service performance period until the measurement date, when service is completed. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Schedule of Estimated Useful Lives of Property and Equipment | The assets are depreciated by the straight-line method, over the estimated useful lives of the related assets as follows. Number of years Furniture and office equipment 5-14 Machinery and equipment 3-7 Computers 2-3 Leasehold improvements shorter of useful life or the term of the lease |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | December 31, 2018 Cost Accumulated Depreciation Net Book Value Machinery and equipment $ 3,603 $ (1,046 ) $ 2,557 Furniture and office equipment 132 (41 ) 91 Computer equipment and software 384 (227 ) 157 Leasehold improvements 6,817 (1,097 ) 5,720 $ 10,936 $ (2,411 ) $ 8,525 December 31, 2017 Cost Accumulated Depreciation Net Book Value Machinery and equipment $ 1,748 $ (698 ) $ 1,050 Furniture and office equipment 92 (26 ) 66 Computer equipment and software 315 (140 ) 175 Leasehold improvements 2,453 (1,499 ) 954 $ 4,608 $ (2,363 ) $ 2,245 |
Inventory, Net (Tables)
Inventory, Net (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory is stated at the lower of cost or market and consists of the following: 2018 2017 Finished goods $ 81 $ 99 Work-in-process 64 119 Raw materials 766 570 $ 911 $ 788 |
Intangibles (Tables)
Intangibles (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangibles Assets | December 31, 2018 Gross Carrying amount Accumulated Amortization Cumulative Impairment Charge Cumulative Currency Translation Net Book Value License $ 669 $ (457 ) $ - $ 11 $ 223 IPR&D assets 61,500 - (300 ) (3,174 ) 58,026 $ 62,169 $ (457 ) $ (300 ) $ (3,163 ) $ 58,249 December 31, 2017 Gross Carrying amount Accumulated Amortization Impairment Charge Cumulative Currency Translation Net Book Value License $ 669 $ (397 ) $ - $ 33 $ 305 IPR&D assets 61,500 - (300 ) 1,831 63,031 $ 62,169 $ (397 ) $ (300 ) $ 1,864 $ 63,336 |
Other Current Liabilities (Tabl
Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Other Liabilities Disclosure [Abstract] | |
Schedule of Other Current Liabilities | Other current liabilities consisted of the following: 2018 2017 Accrued research and development expenses (including clinical trial expenses) $ 9,763 $ 7,008 Payroll and employee-related costs 2,294 1,699 Other current liabilities 1,790 1,119 $ 13,847 $ 9,826 |
Loss Per Share of Common Shar_2
Loss Per Share of Common Shares (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Schedule of Antidilutive Weighted Average Shares Outstanding | The following potentially dilutive securities outstanding at December 31, 2018 and 2017 have been excluded from the computation of diluted weighted average shares outstanding, as they would be antidilutive: 2018 2017 Warrants 2,618,824 2,618,824 Stock options and unvested stock awards 3,748,246 2,775,774 6,367,070 5,394,598 |
Long-Term Debt - Related Party
Long-Term Debt - Related Party (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Schedule of Long-Term Debt | 2018 2017 Long-term debt, net of debt discount of $1,274 $ 14,027 $ 13,138 Less: current portion, net of debt discount of $100 1,100 1,600 $ 12,927 $ 11,538 |
Schedule of Interest Expense | Interest expense, net of interest income recorded for the year ended December 31, 2018 and 2017 was as follows after giving effect to the Third Amendment dated January 31, 2019 as discussed above: December 31 2018 2017 Interest expense – related party $ 1,980 $ 1,850 Amortization of debt discount – related party 1,274 1,181 Interest income (622 ) (149 ) Total interest expense, net of interest income $ 2,632 $ 2,882 |
Schedule of Future Payment of Long-Term Debt | The following table summarizes the future payments that the Company expects to make for long-term debt: Year ending December 31, 2019 $ 1,200 2020 14,100 $ 15,300 |
Stockholders' Equity and Addi_2
Stockholders' Equity and Additional Paid-In Capital (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Stock Options Outstanding Under Different Plans | The table below provides information, as of December 31, 2018, regarding the 2006 Plan, the 2013 Plan, the 2014 Plan and the 2016 Plan under which our equity securities are authorized for issuance to officers, directors, employees, consultants, independent contractors and advisors. Plan Category Number of securities to be issued upon exercise of outstanding awards Weighted average exercise price 2006 Plan 1,140,053 $ 4.09 2013 Plan 3,460 $ 7.31 2014 Plan 613,577 $ 5.23 2016 Plan 1,991,156 $ 3.82 Total 3,748,246 $ 4.14 |
Schedule of Stock Options Activity | Activity related to stock options is as follows: Number of Stock Options Weighted Average Exercise Price Balance outstanding at December 31, 2016 2,167,903 $ 4.45 Granted 303,500 $ 3.72 Exercised (6,377 ) $ 2.50 Forfeited (113,631 ) $ 4.37 Balance outstanding at December 31, 2017 2,351,395 $ 4.44 Granted 1,515,000 $ 3.82 Exercised (39,828 ) $ 2.50 Forfeited (346,891 ) $ 4.47 Balance outstanding at December 31, 2018 3,479,676 $ 4.14 Exercisable at December 31, 2018 2,292,112 $ 4.34 |
Schedule of Exercise Price Range Stock Options Outstanding and Exercisable | Outstanding Exercisable Exercise Price Number Of Options Weighted Average Remaining Contractual Life (Years) Number Of Options Weighted Average Exercise Price $ 0.00 - $ 3.49 508,493 7.47 212,651 $ 2.87 $ 3.50 - $ 4.49 2,211,920 7.60 1,380,852 $ 4.15 $ 4.50 - $ 5.50 691,299 5.37 630,645 $ 4.91 $ 5.50+ 67,964 5.51 67,964 $ 8.13 3,479,676 7.10 2,292,112 $ 4.34 |
Schedule of Restricted Stock Units | Information relating to restricted stock units is as follow: Number of Stock Awards Weighted Avg Fair Value at Grant Date Unvested shares outstanding at January 1, 2016 and December 31, 2016 639,374 3.88 Granted 57,000 $ 4.72 Vested (213,870 ) $ 3.93 Forfeited (58,125 ) $ 3.89 Unvested shares outstanding at December 31, 2017 424,379 $ 3.99 Granted 150,000 $ 4.26 Vested (237,669 ) $ 4.01 Forfeited (68,140 ) $ 3.89 Unvested shares outstanding at December 31, 2018 268,570 $ 4.13 |
Schedule of Fair Value of Options Granted By Using Black-Scholes Option Pricing Assumptions | In determining the amount of stock-based compensation the Company used the Black-Scholes option pricing model to establish the fair value of options granted by applying the following weighted average assumptions: 2018 2017 Volatility 114.68 % 87.22 % Risk free interest rate 2.57 % 2.31 % Expected term in years 5.84 6.3 Expected dividend yield 0.00 % 0.00 % Weighted average fair value per option $ 3.21 $ 3.12 |
Schedule of Stock-based Compensation Expense | The total stock-based compensation expense recorded in the years ended December 31, was as follows: 2018 2017 Research and development $ 696 $ 702 General and administration 2,556 1,648 Cost of revenue 60 60 Total stock-based compensation expense $ 3,312 $ 2,410 |
Schedule of Warrant Activity | Activity related to the warrants is as follows: Number of Warrants Weighted Average Exercise Price Balance outstanding at December 31, 2016 2,068,824 $ 3.63 Issued 550,000 $ 3.34 Balance outstanding at December 31, 2017 and 2018 2,618,824 $ 3.57 |
Revenue and Deferred Revenue (T
Revenue and Deferred Revenue (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Revenue from Contract with Customer [Abstract] | |
Summary of Revenue Comprised | Revenue is comprised of the following: 2018 2017 License revenue $ 2,637 $ - Product revenue 604 502 R&D Service revenue 114 363 $ 3,355 $ 865 |
Summary of Revenue Expected to be Recognized in Future Related to Performance Obligations | The following table presents revenue expected to be recognized in the future related to performance obligations, based on current estimates, that are unsatisfied at December 31, 2018: Total 2019 2020 and thereafter Product revenue 469 - 469 R&D Service revenue 4,703 2,375 2,328 Total $ 5,172 $ 2,375 $ 2,797 |
Summary of Changes in Deferred Revenue | The following table presents changes in the deferred revenue balance for the year ended December 31, 2018: Balance at December 31, 2017 $ 669 Amounts received in 2018 4,815 Recognition of deferred revenue (74 ) Currency translation (238 ) Balance at December 31, 2018 5,172 Short Term 2,375 Long Term 2,797 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of Loss Before Income Tax | Components of the Company’s loss from continuing operations before income taxes are as follows: 2018 2017 United States $ (4,757) $ (7,220 ) Canada (8,177) (10,568 ) Israel (50,666) (21,638 ) Total $ (63,600) $ (39,426 ) |
Schedule of Components of Income Tax (Provision) Benefits | The components of the income tax (provision) benefits are as follows: 2018 2017 Current Tax Canada $ - $ 3 - 3 Deferred Tax Canada - 428 - 428 Total Canada - 431 $ - $ 431 |
Schedule of Effective Income Tax Rate Reconciliation | The Company operates in United States, 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. A reconciliation of the income tax rate with the Company’s effective tax rate and income tax provisions are as follows: 2018 2017 Loss before income taxes $ (63,600 ) $ (39,425 ) Canadian statutory tax rate 26.50 % 26 % Expected recovery of income tax 16,854 10,251 Research and development tax credits 256 227 Change in valuation allowance (14,685 ) (5,496 ) Difference between Canadian and foreign tax rates (1,708 ) 1,011 Other (125 ) 706 Change in tax rates 59 (5,749 Stock based compensation (651 ) (519 ) Income tax benefit $ - $ 431 |
Schedule of Deferred Tax Assets | The deferred tax asset (liability) consists of the following: 2018 2017 Deferred tax assets (liabilities): Net operating losses $ 41,556 $ 31,858 Research and development tax credits 13 350 10,550 Property and equipment 435 581 Reserves and other 1,457 1,250 Interest 858 - Intangible assets (15,546) (16,814 ) Net deferred tax assets 42,110 27,425 Less: valuation allowance (42,110 ) (27,425 ) Net deferred tax assets (liabilities) $ - $ - |
Schedule of NOL's are Available to Reduce Taxable Income of Future Years | At December 31, 2018, the Company had NOL’s aggregating approximately $166.1 million. The NOL’s are available to reduce taxable income of future years expire as follows: United States Canada Israel Total 2024 $ - $ 444 $ - $ 444 2025 - 1,382 - 1,382 2026 10 3,486 - 3,496 2027 446 4,040 - 4,486 2028 718 1,564 - 2,282 2029 672 2,929 - 3,601 2030 2,556 948 - 3,504 2031 3,617 1,173 - 4,790 2032 2,962 - - 2,962 2033 3,126 1,370 - 4,496 2034 5,626 5,131 - 10,757 2035 4,661 1,543 - 6,204 2036 5,323 8,191 - 13,514 2037 6,017 9,204 - 15,221 2038 - 5,432 5,432 No expiration 3,312 - 80,265 83,577 Total losses $ 39,046 $ 46,837 $ 80,265 $ 166,148 |
Operating Leases (Tables)
Operating Leases (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Leases [Abstract] | |
Schedule of Future Annual Minimum Lease Payments | The future annual minimum payments under these leases is as follows: Year ending December 31 2019 $ 902 2020 503 2021 427 2022 36 Total $ 1,868 |
Segment Information (Tables)
Segment Information (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Segment Reporting [Abstract] | |
Schedule of Revenue by Geographical Region | Revenues from external customers are attributed to geographic areas based on location of the contracting customers. 2018 2017 Revenue in Israel $ 435 $ 520 Revenue in China/Hong Kong 2,667 151 Revenue in Europe 253 194 Total $ 3,355 $ 865 |
Schedule of Property and Equipment Attributed to Geographic Areas | Tangible Long Lived Assets (Property and equipment) attributed to geographic areas are as follows: 2018 2017 Property and equipment in Israel $ 8,396 $ 2,116 Property and equipment in United States 52 - Property and equipment Canada (country of domicile) 77 129 Total $ 8,525 $ 2,245 |
Nature of Business and Contin_2
Nature of Business and Continuation of Business (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | Dec. 17, 2018 | Dec. 17, 2018 | Dec. 04, 2018 | Dec. 04, 2018 | Oct. 30, 2017 | Oct. 30, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Jul. 17, 2018 | May 15, 2017 |
Accumulated deficit | $ 207,575 | $ 143,975 | ||||||||
Net cash flows used in operating activities | $ 45,533 | 31,381 | ||||||||
Agreement term | 3 years | |||||||||
Agreement expiration date | May 15, 2020 | |||||||||
Number of stock issued during period | 23,575,410 | |||||||||
Share issued price per share | $ 1.40 | $ 1.40 | $ 3.05 | $ 3.05 | ||||||
Proceeds from issuance of stock | $ 42,932 | $ 71,905 | $ 71,905 | $ 46,558 | 71,905 | |||||
Warrant term | 4 years | 4 years | ||||||||
Number of warrants to purchase common stock | 550,000 | 550,000 | 363,771 | |||||||
Warrants exercise price per share | $ 3.34 | $ 3.34 | ||||||||
Stock issuance costs | $ 4,683 | $ 3,006 | $ 4,683 | |||||||
Net proceeds from issuance of common stock | $ 67,222 | |||||||||
Underwritten Public Offering [Member] | ||||||||||
Number of stock issued during period | 30,665,304 | |||||||||
Share issued price per share | $ 1.40 | $ 1.40 | ||||||||
Net proceeds from issuance of common stock | $ 39,780 | |||||||||
Gross proceeds from issuance of common stock | 42,932 | |||||||||
Share issuance costs | $ 3,152 | |||||||||
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 | |||||||||
License Agreement [Member] | Brii Bio [Member] | ||||||||||
Number of stock issued during period | 2,295,082 | |||||||||
Net proceeds from issuance of common stock | $ 3,626 | |||||||||
Upfront payment received | $ 11,000 | |||||||||
Stock Purchase Agreement [Member] | ||||||||||
Number of stock issued during period | 2,295,082 |
Significant Accounting Polici_4
Significant Accounting Policies (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Deferred offering costs | $ 154 | $ 240 |
Impairment of long-lived assets | 278 | |
Cumulative translation adjustments | 709 | 589 |
Uncertain tax positions or accrued penalties and interest | ||
Fair value of debt outstanding | $ 14,975 | 15,157 |
Maximum [Member] | ||
Effect of cash flow percentage, debt modification | 10.00% | |
IPR&D assets [Member] | ||
Cummulative translation adjustments on assets | $ 4,976 | $ 4,131 |
IPR&D assets [Member] | Minimum [Member] | ||
Cumulative probability of technical and regulatory success, percentage | 6.00% | |
IPR&D assets [Member] | Maximum [Member] | ||
Cumulative probability of technical and regulatory success, percentage | 25.00% | |
IPR&D assets [Member] | Discount Rate [Member] | ||
Percentage on discount rate | 13.50% |
Significant Accounting Polici_5
Significant Accounting Policies - Schedule of Estimated Useful Lives of Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2018 | |
Furniture and Office Equipment [Member] | Minimum [Member] | |
Property and equipment useful lives | 5 years |
Furniture and Office Equipment [Member] | Maximum [Member] | |
Property and equipment useful lives | 14 years |
Machinery and Equipment [Member] | Minimum [Member] | |
Property and equipment useful lives | 3 years |
Machinery and Equipment [Member] | Maximum [Member] | |
Property and equipment useful lives | 7 years |
Computers [Member] | Minimum [Member] | |
Property and equipment useful lives | 2 years |
Computers [Member] | Maximum [Member] | |
Property and equipment useful lives | 3 years |
Leasehold Improvements [Member] | |
Property and equipment useful lives description | shorter of useful life or the term of the lease. |
New Accounting Pronouncements (
New Accounting Pronouncements (Details Narrative) $ in Thousands | Dec. 31, 2018USD ($) |
Accounting Changes and Error Corrections [Abstract] | |
Right-of use assets | $ 1,620 |
Operating lease liability | $ 1,620 |
Property and Equipment (Details
Property and Equipment (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 481 | $ 667 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Property and Equipment cost | $ 10,936 | $ 4,608 |
Accumulated Depreciation | (2,411) | (2,363) |
Net Book Value | 8,525 | 2,245 |
Machinery and Equipment [Member] | ||
Property and Equipment cost | 3,603 | 1,748 |
Accumulated Depreciation | (1,046) | (698) |
Net Book Value | 2,557 | 1,050 |
Furniture and Office Equipment [Member] | ||
Property and Equipment cost | 132 | 92 |
Accumulated Depreciation | (41) | (26) |
Net Book Value | 91 | 66 |
Computer Equipment and Software [Member] | ||
Property and Equipment cost | 384 | 315 |
Accumulated Depreciation | (227) | (140) |
Net Book Value | 157 | 175 |
Leasehold Improvements [Member] | ||
Property and Equipment cost | 6,817 | 2,453 |
Accumulated Depreciation | (1,097) | (1,499) |
Net Book Value | $ 5,720 | $ 954 |
Inventory, Net (Details Narrati
Inventory, Net (Details Narrative) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Inventory Disclosure [Abstract] | ||
Inventory provision | $ 189 | $ 217 |
Inventory, Net - Schedule of In
Inventory, Net - Schedule of Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 81 | $ 99 |
Work-in-process | 64 | 119 |
Raw materials | 766 | 570 |
Inventory net | $ 911 | $ 788 |
Intangibles (Details Narrative)
Intangibles (Details Narrative) - Israel [Member] - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Amortization expenses | $ 61 | $ 63 |
Expected amortization expense until its fully amortized | $ 58 |
Intangibles - Schedule of Intan
Intangibles - Schedule of Intangibles Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Intangible assets, Gross | $ 62,169 | $ 62,169 |
Accumulated Amortization | (457) | (397) |
Cumulative Impairment Charge | (300) | (300) |
Cumulative Currency Translation | (3,163) | 1,864 |
Intangible assets, Net | 58,249 | 63,336 |
License [Member] | ||
Intangible assets, Gross | 669 | 669 |
Accumulated Amortization | (457) | (397) |
Cumulative Impairment Charge | ||
Cumulative Currency Translation | 11 | 33 |
Intangible assets, Net | 223 | 305 |
IPR&D [Member] | ||
Intangible assets, Gross | 61,500 | 61,500 |
Accumulated Amortization | ||
Cumulative Impairment Charge | (300) | (300) |
Cumulative Currency Translation | (3,174) | 1,831 |
Intangible assets, Net | $ 58,026 | $ 63,031 |
Other Current Liabilities - Sch
Other Current Liabilities - Schedule of Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Other Liabilities Disclosure [Abstract] | ||
Accrued research and development expenses (including clinical trial expenses) | $ 9,763 | $ 7,008 |
Payroll and employee-related costs | 2,294 | 1,699 |
Other current liabilities | 1,790 | 1,119 |
Total Other current liabilities | $ 13,847 | $ 9,826 |
Loss Per Share of Common Shar_3
Loss Per Share of Common Shares - Schedule of Antidilutive Weighted Average Shares Outstanding (Details) - shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Antidilutive weighted average shares outstanding | 6,367,070 | 5,394,598 |
Warrants [Member] | ||
Antidilutive weighted average shares outstanding | 2,618,824 | 2,618,824 |
Stock Options and Unvested Stock Awards [Member] | ||
Antidilutive weighted average shares outstanding | 3,748,246 | 2,775,774 |
Long-Term Debt - Related Part_2
Long-Term Debt - Related Party (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | Jul. 17, 2018 | Dec. 06, 2016 | Dec. 31, 2018 | Dec. 31, 2017 | Oct. 30, 2017 | May 06, 2016 | Jul. 25, 2014 |
Number of warrants issued to purchase common stock shares | 363,771 | 550,000 | |||||
Warrants to purchase common shares original expiration date description | Original expiration date of July 25, 2019 to December 6, 2021. | ||||||
Increase in debt discount | $ 386 | ||||||
Exercise price of warrants | $ 3.34 | ||||||
Total debt discount | $ 3,839 | ||||||
Unamortized debt discount | 1,274 | $ 2,163 | |||||
From $3.355 [Member] | |||||||
Number of warrants issued to purchase common stock shares | 1,341,282 | ||||||
Exercise price of warrants | $ 3.355 | ||||||
January 31, 2019 [Member] | |||||||
Increase in debt discount | $ 179 | ||||||
Term loan maturity date | Jun. 30, 2020 | ||||||
Exercise price of warrants | $ 2.75 | ||||||
January 31, 2019 [Member] | From $4.13 [Member] | |||||||
Number of warrants issued to purchase common stock shares | 363,771 | 363,771 | |||||
Exercise price of warrants | $ 4.13 | $ 4.13 | |||||
Extended Maturity For Interest [Member] | |||||||
Debt instrument, extension date, description | May 31, 2018 to December 31, 2018 | ||||||
Extended Maturity For Interest [Member] | January 31, 2019 [Member] | |||||||
Debt instrument, extension date, description | December 31, 2018 to the Amortization Commencement Date (which is defined as the later of July 31, 2019 and, if Sci-B-Vac Phase III clinical trial endpoints are achieved by June 30, 2019, January 31, 2020) | ||||||
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 | ||||||
Debt instrument, extension date, description | |||||||
Term loan maturity date | Dec. 6, 2019 | ||||||
Exit fee | $ 300 | ||||||
Long term debt, gross | $ 15,300 | ||||||
Term loan annual interest rate description | The principal amount of the loan made under the Second Amendment 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 | 13.3125% | ||||||
Perceptive Credit Holdings, LP [Member] | Maximum [Member] | |||||||
Term loan interest rate | 4.00% | ||||||
Perceptive Credit Holdings, LP [Member] | LIBOR [Member] | |||||||
Variable rate, description | one-month LIBOR | ||||||
Debt instrument, variable rate | 1.00% | ||||||
Perceptive Credit Holdings, LP [Member] | Interest Cap [Member] | |||||||
Debt instrument, variable rate | 5.00% | ||||||
Perceptive Credit Holdings, LP [Member] | Applicable Margin [Member] | |||||||
Debt instrument, variable rate | 11.00% | ||||||
Perceptive Credit Holdings, LP [Member] | January 31, 2019 [Member] | |||||||
Debt instrument, extension date, description | from December 6, 2019 to June 30, 2020 | ||||||
Term loan maturity date | Jun. 30, 2020 |
Long-Term Debt - Related Part_3
Long-Term Debt - Related Party - Schedule of Long-Term Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Debt Disclosure [Abstract] | ||
Long-term debt, net of debt discount of $1,274 | $ 14,027 | $ 13,138 |
Less: current portion, net of debt discount of $100 | 1,100 | 1,600 |
Long-term debt | $ 12,927 | $ 11,538 |
Long-Term Debt - Related Part_4
Long-Term Debt - Related Party - Schedule of Long-Term Debt (Details) (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Debt discount | $ 1,274 | $ 2,163 |
Long-term Debt [Member] | ||
Debt discount | 1,274 | 0 |
Debt discount, current | $ 100 | $ 0 |
Long-Term Debt - Related Part_5
Long-Term Debt - Related Party - Schedule of Interest Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Debt Disclosure [Abstract] | ||
Interest expense - related party | $ 1,980 | $ 1,850 |
Amortization of debt discount - related party | 1,274 | 1,181 |
Interest income | (622) | (149) |
Total interest expense, net of interest income | $ 2,632 | $ 2,882 |
Long-Term Debt - Related Part_6
Long-Term Debt - Related Party - Schedule of Future Payment of Long-Term Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Total | $ 14,027 | $ 13,138 |
Long-term Debt [Member] | ||
2,019 | 1,200 | |
2,020 | 14,100 | |
Total | $ 15,300 |
Employee Benefits (Details Narr
Employee Benefits (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Total expense recognized for the period | $ 218 | $ 190 |
Percentage of matching contribution with employees | 25.00% | |
Employees salary rate | 8.33% | |
Research and Development [Member] | ||
Severance payments | $ 24 | 187 |
Cost of Revenues [Member] | ||
Severance payments | $ 50 | |
VBI DE [Member] | ||
Percentage of salary contribution to retirement benefit | 1.50% | |
VBI Cda [Member] | ||
Percentage of salary contribution to retirement benefit | 1.50% |
Stockholders' Equity and Addi_3
Stockholders' Equity and Additional Paid-In Capital (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | Dec. 17, 2018 | Dec. 04, 2018 | Jun. 18, 2018 | Mar. 07, 2018 | Dec. 18, 2017 | Oct. 30, 2017 | Oct. 30, 2017 | Jun. 22, 2017 | Mar. 22, 2017 | Jan. 17, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Jul. 17, 2018 | Nov. 08, 2017 |
Number of stock options exercised during period | 6,377 | 39,828 | ||||||||||||||
Stock option granted | 303,500 | |||||||||||||||
Percentage of stock awards vested | 25.00% | 25.00% | ||||||||||||||
Shares available for issuance | 30,665,304 | 129,782 | 23,575,410 | 156,249 | ||||||||||||
Fair value of common shares of recognized expense | $ 85 | |||||||||||||||
Share issued price per share | $ 1.40 | $ 3.05 | $ 3.05 | |||||||||||||
Proceeds from issuance of stock | $ 42,932 | $ 71,905 | $ 71,905 | $ 46,558 | 71,905 | |||||||||||
Warrant term | 4 years | 4 years | ||||||||||||||
Number of warrants to purchase common stock | 550,000 | 550,000 | 363,771 | |||||||||||||
Warrants exercise price per share | $ 3.34 | $ 3.34 | ||||||||||||||
Stock issuance costs | $ 4,683 | 3,152 | ||||||||||||||
Number of shares issued during new issues | 23,575,410 | |||||||||||||||
Net proceeds from issuance of common stock | $ 67,222 | |||||||||||||||
Payment of stock issuance costs | $ 4,683 | 3,006 | $ 4,683 | |||||||||||||
Stock issuance costs included in other current liabilities | $ 146 | |||||||||||||||
Maximum stock option term | 6 years 1 month 13 days | 5 years 6 months 25 days | ||||||||||||||
Intrinsic value of options outstanding, vested and expected to vest | $ 0 | |||||||||||||||
Intrinsic value of options outstanding | 0 | |||||||||||||||
Intrinsic value of options outstanding, expected to vest | 0 | |||||||||||||||
Unrecognized vested compensation stock option | $ 3,935 | |||||||||||||||
Unrecognized compensation over weighted average period | 1 year 11 months 15 days | |||||||||||||||
Number of restricted stock award vested | 9,281 | |||||||||||||||
Number of restricted stock award vested, value | $ 35 | |||||||||||||||
Fair value of warrants | $ 611 | |||||||||||||||
Board of Directors [Member] | First Anniversary [Member] | ||||||||||||||||
Percentage of stock awards vested | 25.00% | |||||||||||||||
Board of Directors [Member] | Second Anniversary [Member] | ||||||||||||||||
Percentage of stock awards vested | 25.00% | |||||||||||||||
Board of Directors [Member] | Third Anniversary [Member] | ||||||||||||||||
Percentage of stock awards vested | 25.00% | |||||||||||||||
Board of Directors [Member] | Fourth Anniversary [Member] | ||||||||||||||||
Percentage of stock awards vested | 25.00% | |||||||||||||||
Restricted Stock Units (RSUs) [Member] | ||||||||||||||||
Stock option granted | ||||||||||||||||
Fair value of vested restricted stock units | $ 954 | |||||||||||||||
Settlement Agreement [Member] | Kevelt [Member] | ||||||||||||||||
Shares available for issuance | 274,000 | |||||||||||||||
Share issued price per share | $ 4.17 | |||||||||||||||
Proceeds from issuance of stock | $ 1,142 | |||||||||||||||
One Consultants [Member] | ||||||||||||||||
Number of common stock shares issued for services | 25,000 | |||||||||||||||
Fair value of common shares of recognized expense | $ 85 | |||||||||||||||
Brii Bio [Member] | License Agreement [Member] | ||||||||||||||||
Number of shares issued during new issues | 2,295,082 | |||||||||||||||
Share price | $ 1.58 | |||||||||||||||
Net proceeds from issuance of common stock | $ 3,626 | |||||||||||||||
2016 Plan [Member] | ||||||||||||||||
Stock option granted | 135,000 | 23,250 | ||||||||||||||
2006 Plan [Member] | ||||||||||||||||
Number of options outstanding | 1,140,053 | |||||||||||||||
2013 Plan [Member] | ||||||||||||||||
Number of options outstanding | 3,460 | |||||||||||||||
2014 Plan [Member] | ||||||||||||||||
Number of options outstanding | 613,557 | |||||||||||||||
2016 VBI Equity Incentive Plan [Member] | ||||||||||||||||
Shares available for issuance | 5,213,166 | |||||||||||||||
Number of options outstanding | 1,722,586 | |||||||||||||||
Exercise price for option percentage | 100.00% | |||||||||||||||
Maximum stock option term | 10 years | |||||||||||||||
2016 VBI Equity Incentive Plan [Member] | One Participant [Member] | ||||||||||||||||
Maximum percentage of common shares issued and outstanding | 5.00% | |||||||||||||||
2016 VBI Equity Incentive Plan [Member] | Restricted Stock Units (RSUs) [Member] | ||||||||||||||||
Number of common shares available for issuance | 268,570 | |||||||||||||||
2016 VBI Equity Incentive Plan [Member] | Maximum [Member] | ||||||||||||||||
Maximum percentage of common shares issued and outstanding | 10.00% |
Stockholders' Equity and Addi_4
Stockholders' Equity and Additional Paid-In Capital - Schedule of Stock Options Outstanding Under Different Plans (Details) | Dec. 31, 2018$ / sharesshares |
Number of securities to be issued upon exercise of outstanding awards | shares | 3,748,246 |
Weighted average exercise price | $ / shares | $ 4.14 |
2006 Plan [Member] | |
Number of securities to be issued upon exercise of outstanding awards | shares | 1,140,053 |
Weighted average exercise price | $ / shares | $ 4.09 |
2013 Plan [Member] | |
Number of securities to be issued upon exercise of outstanding awards | shares | 3,460 |
Weighted average exercise price | $ / shares | $ 7.31 |
2014 Plan [Member] | |
Number of securities to be issued upon exercise of outstanding awards | shares | 613,577 |
Weighted average exercise price | $ / shares | $ 5.23 |
2016 Plan [Member] | |
Number of securities to be issued upon exercise of outstanding awards | shares | 1,991,156 |
Weighted average exercise price | $ / shares | $ 3.82 |
Stockholders' Equity and Addi_5
Stockholders' Equity and Additional Paid-In Capital - Schedule of Stock Options Activity (Details) - $ / shares | Jan. 17, 2017 | Jun. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Number of Stock Options, Granted | 303,500 | |||
Number of Stock Options, Exercised | (6,377) | (39,828) | ||
Stock Options [Member] | ||||
Number of Stock Options Outstanding, Beginning Balance | 2,351,395 | 2,351,395 | 2,167,903 | |
Number of Stock Options, Granted | 1,515,000 | 303,500 | ||
Number of Stock Options, Exercised | (39,828) | (6,377) | ||
Number of Stock Options, Forfeited | (346,891) | (113,631) | ||
Number of Stock Options Outstanding, Ending Balance | 3,479,676 | 2,351,395 | ||
Number of Stock Options, Exercisable | 2,292,112 | |||
Weighted Average Exercise Price, Beginning Balance | $ 4.44 | $ 4.44 | $ 4.45 | |
Weighted Average Exercise Price, Granted | 3.82 | 3.72 | ||
Weighted Average Exercise Price, Exercised | 2.50 | 2.50 | ||
Weighted Average Exercise Price, Forfeited | 4.47 | 4.37 | ||
Weighted Average Exercise Price, Ending Balance | 4.14 | 4.44 | ||
Weighted Average Exercise Price, Exercisable | $ 4.34 |
Stockholders' Equity and Addi_6
Stockholders' Equity and Additional Paid-In Capital - Schedule of Exercise Price Range Stock Options Outstanding and Exercisable (Details) | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Number of Options, Outstanding | shares | 3,479,676 |
Options Outstanding, Weighted Average Remaining Contractual Life (Years) | 7 years 1 month 6 days |
Number of Options Exercisable | shares | 2,292,112 |
Options Exercisable, Weighted Average Exercise Price | $ 4.34 |
Range One [Member] | |
Exercise Price, lower limit | 0 |
Exercise Price, upper limit | $ 3.49 |
Number of Options, Outstanding | shares | 508,493 |
Options Outstanding, Weighted Average Remaining Contractual Life (Years) | 7 years 5 months 20 days |
Number of Options Exercisable | shares | 212,651 |
Options Exercisable, Weighted Average Exercise Price | $ 2.87 |
Range Two [Member] | |
Exercise Price, lower limit | 3.50 |
Exercise Price, upper limit | $ 4.49 |
Number of Options, Outstanding | shares | 2,211,920 |
Options Outstanding, Weighted Average Remaining Contractual Life (Years) | 7 years 7 months 6 days |
Number of Options Exercisable | shares | 1,380,852 |
Options Exercisable, Weighted Average Exercise Price | $ 4.15 |
Range Three [Member] | |
Exercise Price, lower limit | 4.50 |
Exercise Price, upper limit | $ 5.50 |
Number of Options, Outstanding | shares | 691,299 |
Options Outstanding, Weighted Average Remaining Contractual Life (Years) | 5 years 4 months 13 days |
Number of Options Exercisable | shares | 630,645 |
Options Exercisable, Weighted Average Exercise Price | $ 4.91 |
Range Four [Member] | |
Exercise Price, lower limit | $ 5.50 |
Number of Options, Outstanding | shares | 67,964 |
Options Outstanding, Weighted Average Remaining Contractual Life (Years) | 5 years 6 months 3 days |
Number of Options Exercisable | shares | 67,964 |
Options Exercisable, Weighted Average Exercise Price | $ 8.13 |
Stockholders' Equity and Addi_7
Stockholders' Equity and Additional Paid-In Capital - Schedule of Restricted Stock Units (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Number of Stock Awards, Granted | 303,500 | |
Weighted Average Fair Value at Grant Date, Granted | $ 3.21 | $ 3.12 |
Restricted Stock Units (RSUs) [Member] | ||
Number of Stock Awards, Unvested shares outstanding beginning balance | 424,379 | 639,374 |
Number of Stock Awards, Granted | 150,000 | 57,000 |
Number of Stock Awards, Vested | (237,669) | (213,870) |
Number of Stock Awards, Forfeited | (68,140) | (58,125) |
Number of Stock Awards, Unvested shares outstanding ending balance | 268,570 | 424,379 |
Weighted Average Fair Value at Grant Date, Unvested shares outstanding beginning balance | $ 3.99 | $ 3.88 |
Weighted Average Fair Value at Grant Date, Granted | 4.26 | 4.72 |
Weighted Average Fair Value at Grant Date, Vested | 4.01 | 3.93 |
Weighted Average Fair Value at Grant Date, Forfeited | 3.89 | 3.89 |
Weighted Average Fair Value at Grant Date, Unvested shares outstanding | $ 4.13 | $ 3.99 |
Stockholders' Equity and Addi_8
Stockholders' Equity and Additional Paid-In Capital - Schedule of Fair Value of Options Granted By Using Black-Scholes Option Pricing Assumptions (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Stockholders' Equity Note [Abstract] | ||
Volatility | 114.68% | 87.22% |
Risk free interest rate | 2.57% | 2.31% |
Expected term in years | 5 years 10 months 3 days | 6 years 3 months 19 days |
Expected dividend yield | 0.00% | 0.00% |
Weighted average fair value per option | $ 3.21 | $ 3.12 |
Stockholders' Equity and Addi_9
Stockholders' Equity and Additional Paid-In Capital - Schedule of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Total stock-based compensation expense | $ 3,312 | $ 2,410 |
Research and Development [Member] | ||
Total stock-based compensation expense | 696 | 702 |
General and Administrative [Member] | ||
Total stock-based compensation expense | 2,556 | 1,648 |
Cost of Revenues [Member] | ||
Total stock-based compensation expense | $ 60 | $ 60 |
Stockholders' Equity and Add_10
Stockholders' Equity and Additional Paid-In Capital - Schedule of Warrant Activity (Details) - Warrants [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Number of Warrants, beginning balance | 2,618,824 | 2,068,824 |
Number of Warrants, Issued | 550,000 | |
Number of Warrants, ending balance | 2,618,824 | 2,618,824 |
Weighted Average Exercise Price, beginning balance | $ 3.57 | $ 3.63 |
Weighted Average Exercise Price, Issued | 3.34 | |
Weighted Average Exercise Price, ending balance | $ 3.57 | $ 3.57 |
Revenue and Deferred Revenue (D
Revenue and Deferred Revenue (Details Narrative) $ in Thousands | Dec. 04, 2018USD ($)PerformanceObligationshares | Oct. 30, 2017shares | Dec. 31, 2018USD ($) |
Number of shares issued during new issues | shares | 23,575,410 | ||
Remaining performance obligation, deemed to be initial transaction price | $ 5,172 | ||
License Agreement [Member] | Brii Bio [Member] | |||
Initial collaboration, non-refundable upfront payment | $ 11,000 | ||
Number of shares issued during new issues | shares | 2,295,082 | ||
Value of shares issued during new issues | $ 3,600 | ||
Remaining performance obligation, deemed to be initial transaction price | $ 7,400 | ||
Number of performance obligations | PerformanceObligation | 2 | ||
Additional potential regulatory and sales milestone payments | $ 117,500 | ||
Performance obligation, transfer description | The Company recognized the VBI-2601 license when it was transferred and Brii Bio is able to use and benefit from the license. The R&D Services will be satisfied over time as services are rendered using the “cost-to-cost” input method as this method represents the most accurate depiction of the transfer of services based on the types of costs expected to be incurred. | ||
License Agreement [Member] | Brii Bio [Member] | VBI-2601 [Member] | |||
Remaining performance obligation, deemed to be initial transaction price | $ 4,800 | ||
License Agreement [Member] | Brii Bio [Member] | R&D Services [Member] | |||
Remaining performance obligation, deemed to be initial transaction price | 2,600 | ||
Distribution Agreement [Member] | |||
Payment of termination to previous third party on distribution rights | $ 6,000 |
Revenue and Deferred Revenue -
Revenue and Deferred Revenue - Summary of Revenue Comprised (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Revenues | $ 3,355 | $ 865 |
License [Member] | ||
Revenues | 2,637 | |
Product Revenue [Member] | ||
Revenues | 604 | 502 |
R&D Service Revenue [Member] | ||
Revenues | $ 114 | $ 363 |
Summary of Revenue Expected to
Summary of Revenue Expected to be Recognized in Future Related to Performance Obligations (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Revenue remaining performance obligations | $ 5,172 |
2019 [Member] | |
Revenue remaining performance obligations | 2,375 |
2020 and Thereafter [Member] | |
Revenue remaining performance obligations | 2,797 |
Product Revenue [Member] | |
Revenue remaining performance obligations | 469 |
Product Revenue [Member] | 2019 [Member] | |
Revenue remaining performance obligations | |
Product Revenue [Member] | 2020 and Thereafter [Member] | |
Revenue remaining performance obligations | 469 |
R&D Service Revenue [Member] | |
Revenue remaining performance obligations | 4,703 |
R&D Service Revenue [Member] | 2019 [Member] | |
Revenue remaining performance obligations | 2,375 |
R&D Service Revenue [Member] | 2020 and Thereafter [Member] | |
Revenue remaining performance obligations | $ 2,328 |
Revenue and Deferred Revenue _2
Revenue and Deferred Revenue - Summary of Changes in Deferred Revenue (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Revenue from Contract with Customer [Abstract] | ||
Balance at December 31, 2017 | $ 669 | |
Amounts received in 2018 | 4,815 | |
Recognition of deferred revenue | (74) | |
Currency translation | (238) | |
Balance at December 31, 2018 | 5,172 | |
Short Term | 2,375 | |
Long Term | $ 2,797 | $ 669 |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Statutory income tax rate | 26.50% | 26.00% |
Federal income tax rate | 15.00% | 15.00% |
Provincial income tax rate | 11.50% | 11.00% |
Income tax description | On December 22, 2017, the United States enacted tax reform legislation through the Tax Cuts and Jobs Act, which significantly changes the existing U.S. tax laws, including a reduction in the corporate tax rate from 35% to 21%, a move from a worldwide tax system to a semi-territorial system, a change in the treatment of operating loss carryforwards generated subsequent to 2017 fiscal year as well as other changes. | |
Net operating loss carryforwards | $ 166,148 | |
Operating loss carryovers acquisition | 29,000 | |
Research and development | $ 38,467 | $ 20,918 |
Minimum [Member] | ||
Ownership percentage | 50.00% | |
Israel [Member] | ||
Statutory income tax rate | 23.00% | 25.00% |
Net operating loss carryforwards | $ 80,265 | $ 44,900 |
United States [Member] | ||
Net operating loss carryforwards | $ 39,046 | 35,300 |
Tax credit offset taxable income expiration | expire beginning in 2026 | |
Canada [Member] | ||
Net operating loss carryforwards | $ 46,837 | 44,900 |
Tax credit offset taxable income expiration | expire beginning in 2024 | |
Investment tax credit | $ 4,900 | 5,000 |
Research and development | $ 17,200 | $ 17,000 |
Income Taxes - Schedule of Loss
Income Taxes - Schedule of Loss Before Income Tax (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income loss from continuing operation before income tax | $ (63,600) | $ (39,426) |
United States [Member] | ||
Income loss from continuing operation before income tax | (4,757) | (7,220) |
Canada [Member] | ||
Income loss from continuing operation before income tax | (8,177) | (10,568) |
Israel [Member] | ||
Income loss from continuing operation before income tax | $ (50,666) | $ (21,638) |
Income Taxes - Schedule of Comp
Income Taxes - Schedule of Components of Income Tax (Provision) Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Current Tax | $ 3 | |
Deferred Tax | 428 | |
Total | 431 | |
Canada [Member] | ||
Current Tax | 3 | |
Deferred Tax | 428 | |
Total | $ 431 |
Income Taxes - Schedule of Effe
Income Taxes - Schedule of Effective Income Tax Rate Reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Loss before income taxes | $ (63,600) | $ (39,426) |
Canadian statutory tax rate | 26.50% | 26.00% |
Expected recovery of income tax | $ 16,854 | $ 10,251 |
Research and development tax credits | 256 | 227 |
Change in valuation allowance | (14,685) | (5,496) |
Difference between Canadian and foreign tax rates | (1,708) | 1,011 |
Other | (125) | 706 |
Change in tax rates | 59 | (5,749) |
Stock based compensation | (651) | (519) |
Income tax benefit | $ 431 |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Income Tax Disclosure [Abstract] | ||
Net operating losses | $ 41,556 | $ 31,858 |
Research and development tax credits | 13,350 | 10,550 |
Property and equipment | 435 | 581 |
Reserves and other | 1,457 | 1,250 |
Interest | 858 | |
Intangible assets | (15,546) | (16,814) |
Net deferred tax assets | 42,110 | 27,425 |
Less: valuation allowance | (42,110) | (27,425) |
Net deferred tax assets (liabilities) | $ 0 | $ 0 |
Income Taxes - Schedule of NOL'
Income Taxes - Schedule of NOL's are Available to Reduce Taxable Income of Future Years (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Total losses | $ 166,148 | |
2024 [Member] | ||
Total losses | 444 | |
2025 [Member] | ||
Total losses | 1,382 | |
2026 [Member] | ||
Total losses | 3,496 | |
2027 [Member] | ||
Total losses | 4,486 | |
2028 [Member] | ||
Total losses | 2,282 | |
2029 [Member] | ||
Total losses | 3,601 | |
2030 [Member] | ||
Total losses | 3,504 | |
2031 [Member] | ||
Total losses | 4,790 | |
2032 [Member] | ||
Total losses | 2,962 | |
2033 [Member] | ||
Total losses | 4,496 | |
2034 [Member] | ||
Total losses | 10,757 | |
2035 [Member] | ||
Total losses | 6,204 | |
2036 [Member] | ||
Total losses | 13,514 | |
2037 [Member] | ||
Total losses | 15,221 | |
2038 [Member] | ||
Total losses | 5,432 | |
No Expiration [Member] | ||
Total losses | 83,577 | |
United States [Member] | ||
Total losses | 39,046 | $ 35,300 |
United States [Member] | 2024 [Member] | ||
Total losses | ||
United States [Member] | 2025 [Member] | ||
Total losses | ||
United States [Member] | 2026 [Member] | ||
Total losses | 10 | |
United States [Member] | 2027 [Member] | ||
Total losses | 446 | |
United States [Member] | 2028 [Member] | ||
Total losses | 718 | |
United States [Member] | 2029 [Member] | ||
Total losses | 672 | |
United States [Member] | 2030 [Member] | ||
Total losses | 2,556 | |
United States [Member] | 2031 [Member] | ||
Total losses | 3,617 | |
United States [Member] | 2032 [Member] | ||
Total losses | 2,962 | |
United States [Member] | 2033 [Member] | ||
Total losses | 3,126 | |
United States [Member] | 2034 [Member] | ||
Total losses | 5,626 | |
United States [Member] | 2035 [Member] | ||
Total losses | 4,661 | |
United States [Member] | 2036 [Member] | ||
Total losses | 5,323 | |
United States [Member] | 2037 [Member] | ||
Total losses | 6,017 | |
United States [Member] | 2038 [Member] | ||
Total losses | ||
United States [Member] | No Expiration [Member] | ||
Total losses | 3,312 | |
Canada [Member] | ||
Total losses | 46,837 | 44,900 |
Canada [Member] | 2024 [Member] | ||
Total losses | 444 | |
Canada [Member] | 2025 [Member] | ||
Total losses | 1,382 | |
Canada [Member] | 2026 [Member] | ||
Total losses | 3,486 | |
Canada [Member] | 2027 [Member] | ||
Total losses | 4,040 | |
Canada [Member] | 2028 [Member] | ||
Total losses | 1,564 | |
Canada [Member] | 2029 [Member] | ||
Total losses | 2,929 | |
Canada [Member] | 2030 [Member] | ||
Total losses | 948 | |
Canada [Member] | 2031 [Member] | ||
Total losses | 1,173 | |
Canada [Member] | 2032 [Member] | ||
Total losses | ||
Canada [Member] | 2033 [Member] | ||
Total losses | 1,370 | |
Canada [Member] | 2034 [Member] | ||
Total losses | 5,131 | |
Canada [Member] | 2035 [Member] | ||
Total losses | 1,543 | |
Canada [Member] | 2036 [Member] | ||
Total losses | 8,191 | |
Canada [Member] | 2037 [Member] | ||
Total losses | 9,204 | |
Canada [Member] | 2038 [Member] | ||
Total losses | 5,432 | |
Canada [Member] | No Expiration [Member] | ||
Total losses | ||
Israel [Member] | ||
Total losses | 80,265 | $ 44,900 |
Israel [Member] | 2024 [Member] | ||
Total losses | ||
Israel [Member] | 2025 [Member] | ||
Total losses | ||
Israel [Member] | 2026 [Member] | ||
Total losses | ||
Israel [Member] | 2027 [Member] | ||
Total losses | ||
Israel [Member] | 2028 [Member] | ||
Total losses | ||
Israel [Member] | 2029 [Member] | ||
Total losses | ||
Israel [Member] | 2030 [Member] | ||
Total losses | ||
Israel [Member] | 2031 [Member] | ||
Total losses | ||
Israel [Member] | 2032 [Member] | ||
Total losses | ||
Israel [Member] | 2033 [Member] | ||
Total losses | ||
Israel [Member] | 2034 [Member] | ||
Total losses | ||
Israel [Member] | 2035 [Member] | ||
Total losses | ||
Israel [Member] | 2036 [Member] | ||
Total losses | ||
Israel [Member] | 2037 [Member] | ||
Total losses | ||
Israel [Member] | 2038 [Member] | ||
Total losses | ||
Israel [Member] | No Expiration [Member] | ||
Total losses | $ 80,265 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) € in Thousands, $ in Thousands | Sep. 13, 2018USD ($)VaccinatedChildren | Jun. 30, 2015USD ($) | Jun. 30, 2015EUR (€) | Dec. 31, 2018USD ($) | Dec. 31, 2018EUR (€) | Dec. 31, 2017USD ($) | Dec. 31, 2018EUR (€) |
Cumulative net sales | $ | $ 3,355 | $ 865 | |||||
Sci-B-Vac [Member] | |||||||
Number of children vaccinated | VaccinatedChildren | 428,000 | ||||||
Seeking damages | $ | $ 501,467 | ||||||
Minimum [Member] | |||||||
Royalty fees percentage | 0.75% | 0.75% | |||||
Sublicensing fees percentage | 5.00% | 5.00% | |||||
Maximum [Member] | |||||||
Royalty fees percentage | 1.75% | 1.75% | |||||
Sublicensing fees percentage | 25.00% | 25.00% | |||||
Euro Currency [Member] | Seller [Member] | VBI [Member] | |||||||
Due to related party | € 3,500 | ||||||
Cumulative net sales | € 50,000 | ||||||
Euro Currency [Member] | Seller [Member] | VBI and Sublicenses [Member] | |||||||
Cumulative net sales | € 100,000 | ||||||
Euro Currency [Member] | Minimum [Member] | Patents [Member] | |||||||
Contingent payments | $ | $ 50 | ||||||
Euro Currency [Member] | Maximum [Member] | Patents [Member] | |||||||
Contingent payments | $ | $ 1,000 | ||||||
Euro Currency [Member] | Scenario One [Member] | Minimum [Member] | |||||||
Contingent payments | 500 | ||||||
Euro Currency [Member] | Scenario One [Member] | Maximum [Member] | |||||||
Contingent payments | 1,000 | ||||||
Euro Currency [Member] | Scenario Two [Member] | |||||||
Contingent payments | 25,000 | ||||||
Euro Currency [Member] | Scenario Two [Member] | Minimum [Member] | |||||||
Contingent payments | 750 | ||||||
Euro Currency [Member] | Scenario Two [Member] | Maximum [Member] | |||||||
Contingent payments | 1,500 | ||||||
Euro Currency [Member] | Scenario Two (A) [Member] | |||||||
Contingent payments | 50,000 | ||||||
Euro Currency [Member] | Scenario Two (A) [Member] | Minimum [Member] | |||||||
Contingent payments | 1,000 | ||||||
Euro Currency [Member] | Scenario Two (A) [Member] | Maximum [Member] | |||||||
Contingent payments | 2,000 | ||||||
Euro Currency [Member] | Scenario Three [Member] | |||||||
Contingent payments | 25,000 | ||||||
Euro Currency [Member] | Scenario Three [Member] | Minimum [Member] | |||||||
Contingent payments | 375 | ||||||
Euro Currency [Member] | Scenario Three [Member] | Maximum [Member] | |||||||
Contingent payments | 750 | ||||||
Euro Currency [Member] | Scenario Three (A) [Member] | |||||||
Contingent payments | 50,000 | ||||||
Euro Currency [Member] | Scenario Three (A) [Member] | Minimum [Member] | |||||||
Contingent payments | 375 | ||||||
Euro Currency [Member] | Scenario Three (A) [Member] | Maximum [Member] | |||||||
Contingent payments | 750 | ||||||
Euro Currency [Member] | Scenario Three (B) [Member] | |||||||
Contingent payments | 75,000 | ||||||
Euro Currency [Member] | Scenario Three (B) [Member] | Minimum [Member] | |||||||
Contingent payments | 500 | ||||||
Euro Currency [Member] | Scenario Three (B) [Member] | Maximum [Member] | |||||||
Contingent payments | 1,000 | ||||||
Euro Currency [Member] | Scenario Three (C) [Member] | |||||||
Contingent payments | 100,000 | ||||||
Euro Currency [Member] | Scenario Three (C) [Member] | Minimum [Member] | |||||||
Contingent payments | 500 | ||||||
Euro Currency [Member] | Scenario Three (C) [Member] | Maximum [Member] | |||||||
Contingent payments | € 1,000 | ||||||
NIS Currency [Member] | Sci-B-Vac [Member] | |||||||
Seeking damages | $ | $ 1,879,500 | ||||||
Sale and Purchase Agreement [Member] | |||||||
Transfer payment paid by company | $ | $ 110 | ||||||
Sale and Purchase Agreement [Member] | Euro Currency [Member] | |||||||
Transfer payment paid by company | € 102 | ||||||
Ferring License Agreement [Member] | |||||||
Royalty fees percentage | 7.00% | 7.00% | |||||
Royalty payments | $ | $ 42 | 35 | |||||
Non-royalty consideration percentage | 30.00% | 30.00% | |||||
License period | We are to pay Ferring the above-mentioned royalties on a country-by-country basis until the date which is 10 years after the date of commencement of the first royalty year in respect of such country Until the 30th day prior to the expiration of the first license period, we have the option to extend the Ferring License Agreement in respect of all the countries that still make up the territory for an additional 7 years by paying Ferring $100. Royalties will continue to be payable for the duration of the extended license periods. When the license has been in effect for, and elapsed after, a 17 year license period with respect to a country in the territory, we will thereafter have a royalty-free license to market in such country and when all the license periods have expired in each country in the territory. | We are to pay Ferring the above-mentioned royalties on a country-by-country basis until the date which is 10 years after the date of commencement of the first royalty year in respect of such country Until the 30th day prior to the expiration of the first license period, we have the option to extend the Ferring License Agreement in respect of all the countries that still make up the territory for an additional 7 years by paying Ferring $100. Royalties will continue to be payable for the duration of the extended license periods. When the license has been in effect for, and elapsed after, a 17 year license period with respect to a country in the territory, we will thereafter have a royalty-free license to market in such country and when all the license periods have expired in each country in the territory. | |||||
Ferring License Agreement [Member] | SciGen Singapore [Member] | |||||||
Royalty fees percentage | 5.00% | 5.00% | |||||
Royalty payments | $ | $ 30 | $ 25 | |||||
Ferring License Agreement [Member] | One-time Lump Sum Payment [Member] | |||||||
Royalty payable | $ | $ 100 |
Operating Leases (Details Narra
Operating Leases (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Operating leases expiration | 2,022 | |
Operating leases, rent expense | $ 992 | $ 919 |
SciVac [Member] | Non-cancelable Lease Agreement [Member] | January 15, 2019 [Member] | ||
Lease agreement term | 3 years | |
Lease revenue | $ 85 |
Operating Leases - Schedule of
Operating Leases - Schedule of Future Annual Minimum Lease Payments (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Leases [Abstract] | |
2,019 | $ 902 |
2,020 | 503 |
2,021 | 427 |
2,022 | 36 |
Total | $ 1,868 |
Segment Information (Details Na
Segment Information (Details Narrative) | 12 Months Ended | |
Dec. 31, 2018USD ($)VaccinatedChildren | Dec. 31, 2017USD ($) | |
Sales Revenue, Net [Member] | Customer 1 [Member] | ||
Concentration risk percentage | 79.00% | 25.00% |
Sales Revenue, Net [Member] | Customer 2 [Member] | ||
Concentration risk percentage | 17.00% | |
Sales Revenue, Net [Member] | Customer 3 [Member] | ||
Concentration risk percentage | 17.00% | |
Sales Revenue, Net [Member] | Customer 4 [Member] | ||
Concentration risk percentage | 12.00% | |
Sales Revenue, Net [Member] | Customer 5 [Member] | ||
Concentration risk percentage | 11.00% | |
Canada [Member] | ||
Number of operating segment | VaccinatedChildren | 1 | |
Revenue | $ |
Segment Information - Schedule
Segment Information - Schedule of Revenue by Geographical Region (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Revenue | $ 3,355 | $ 865 |
Israel [Member] | ||
Revenue | 435 | 520 |
China/Hong Kong | ||
Revenue | 2,667 | 151 |
Europe [Member] | ||
Revenue | $ 253 | $ 194 |
Segment Information - Schedul_2
Segment Information - Schedule of Property and Equipment Attributed to Geographic Areas (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Property and equipment, net | $ 8,525 | $ 2,245 |
Israel [Member] | ||
Property and equipment, net | 8,396 | 2,116 |
United States [Member] | ||
Property and equipment, net | 52 | |
Canada [Member] | ||
Property and equipment, net | $ 77 | $ 129 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Revenue | $ 3,355 | $ 865 |
OPKO Bio [Member] | ||
Revenue | $ 0 | $ 4 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - shares | Jan. 31, 2019 | Mar. 07, 2018 | Mar. 22, 2017 | Dec. 31, 2017 | Jan. 15, 2019 |
Stock option granted | 303,500 | ||||
2016 Plan [Member] | |||||
Stock option granted | 135,000 | 23,250 | |||
Subsequent Event [Member] | SciVac [Member] | Non-cancelable Lease Agreement [Member] | |||||
Lease agreement term | 3 years | ||||
Subsequent Event [Member] | 2016 Plan [Member] | Stock Options [Member] | |||||
Stock option granted | 3,900,000 | ||||
Stock option exercisable to vest | 3,710,000 | ||||
Stock option vested | 190,000 | ||||
Stock option vest period | 36 months | ||||
Stock option expiration date | Jan. 31, 2029 |