UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

[X]	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended March 31, 2018

 

OR

[  ]	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from _______ to

 

Commission file number: 001-37769

 

 

VBI VACCINES INC.

(Exact name of registrant as specified in its charter)

 

British Columbia, Canada		N/A
(State or other jurisdiction of		(I.R.S. Employer
incorporation or organization)		Identification No.)

 

222 Third Street, Suite 2241 Cambridge, Massachusetts		02142
(Address of principal executive offices)		(Zip Code)

 

Registrant’s telephone number, including area code: 617-830-3031

 

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes [X] No [  ]

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes [X] No [  ]

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer”, and “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer [  ]	Accelerated filer [X]
Non-accelerated filer [  ] (Do not check if a smaller reporting company)	Smaller reporting company [  ]
	Emerging growth company [X]

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [X]

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes [  ] No [X]

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

 

Common Shares, no par value per share	64,215,727
(Class)	Outstanding at April 25, 2018

 

 

 

VBI VACCINES INC.

FORM 10-Q FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2018

 

TABLE OF CONTENTS

 

		Page
PART I - FINANCIAL INFORMATION		5
Item 1.	Condensed Consolidated Financial Statements	5
	Condensed Consolidated Balance Sheets - March 31, 2018 (unaudited) and December 31, 2017	5
	Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2018 and 2017 (unaudited)	6
	Condensed Consolidated Statements of Stockholders’ Equity (unaudited)	7
	Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2018 and 2017 (unaudited)	8
	Notes to Condensed Consolidated Financial Statements (unaudited)	9
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	20
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	27
Item 4.	Controls and Procedures	27
PART II - OTHER INFORMATION		28
Item 1.	Legal Proceedings	28
Item 1A.	Risk Factors	28
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	28
Item 3.	Defaults Upon Senior Securities	28
Item 4.	Mine Safety Disclosure	28
Item 5.	Other Information	28
Item 6.	Exhibits	28
Signatures		30

 

 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND OTHER INFORMATION
CONTAINED IN THIS REPORT

 

This quarterly report on Form 10-Q (this “Form 10-Q”) contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements give our current expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. You can find many (but not all) of these statements by looking for words such as “approximates,” “believes,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “would,” “should,” “could,” “will”, “may,” or other similar expressions in this Form 10-Q. In particular, these include statements relating to future actions; prospective products, applications, customers and technologies; future performance or results of anticipated products; anticipated expenses; and projected financial results. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from our historical experience and our present expectations or projections described under the sections in this Quarterly Report on Form 10-Q entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and in the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 2017 annual report on the Form 10-K filed with the Securities and Exchange Commission on February 26, 2018. Factors that could cause actual results to differ from those discussed in the forward-looking statements include, but are not limited to:

 

●	the timing of, and our ability to, obtain and maintain regulatory approvals for our clinical trials, products and product candidates;
●	the timing and results of our ongoing and planned clinical trials for products and product candidates;
●	the amount of funds we require for our immuno-oncology and infectious disease vaccine candidate pipeline;
●	the potential benefits of strategic partnership agreements and our ability to enter into strategic partnership arrangements;
●	our ability to effectively execute and deliver our plans related to commercialization, marketing and manufacturing capabilities and strategy;
●	our ability to license our intellectual property;
●	our ability to maintain a good relationship with our employees;
●	the suitability and adequacy of our office, manufacturing and research facilities and our ability to secure term extensions or expansions of leased space;
●	our ability to manufacture, or to have manufactured, any products we develop to the standards and requirements of regulatory agencies;
●	the ability of our vendors to manufacture and deliver materials that meet regulatory agency and our standards and requirements in order to meet planned timelines and milestones;
●	any disruption in the operations of our manufacturing facility where we manufacture all of our clinical and commercial supplies of Sci-B-Vac™;
●	our compliance with all laws, rules and regulations applicable to our business and products;
●	our ability to continue as a going concern;
●	our history of losses;
●	our ability to generate revenues and achieve profitability;
●	emerging competition and rapidly advancing technology in our industry that may outpace our technology;
●	customer demand for our products and product candidates;
●	the impact of competitive or alternative products, technologies and pricing;
●	general economic conditions and events and the impact they may have on us and our potential customers;
●	our ability to obtain adequate financing in the future on reasonable terms, as and when we need it;
●	our ability to implement network systems and controls that are effective at preventing cyber-attacks, malware intrusions, malicious viruses and ransomware threats;
●	our ability to secure and maintain protection over our intellectual property;
●	changes to legal and regulatory processes for biosimilar approval and marketing could reduce the duration of market exclusivity for our products;
●	our ability to maintain our existing licenses for intellectual property;
●	our success at managing the risks involved in the foregoing items; and
●	other factors discussed in this Form 10-Q.

 

 

Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for us to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

 

Unless otherwise stated or the context otherwise requires, the terms “VBI,” “we,” “us,” “our” and the “Company” refer to VBI Vaccines Inc. and its subsidiaries.

 

Unless indicated otherwise, all references to the U.S. Dollar, Dollar or $ are to the United States Dollar, the legal currency of the United States of America and all references to € mean Euros, the legal currency of the European Union. We may also refer to NIS, which is the New Israeli Shekel, the legal currency of Israel, and the Canadian Dollar or CAD, which is the legal currency of Canada.

 

Except for per share amounts or as otherwise specified to be in millions, amounts presented are stated in thousands.

 

 

PART I—FINANCIAL INFORMATION

 

Item 1. Condensed Consolidated Financial Statements

 

VBI Vaccines Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(in thousands, except share amounts)

 

		March 31, 2018				December 31, 2017
		(unaudited)
CURRENT ASSETS
Cash		$	58,094			$	67,694
Accounts receivable, net			167				143
Inventory, net			783				788
Prepaid expenses			371				951
Other current assets			937				850
Total current assets			60,352				70,426
NON-CURRENT ASSETS
Other long-term assets			1,196				675
Property and equipment, net			2,942				2,245
Intangible assets, net			61,600				63,336
Goodwill			8,731				8,974
Total non-current assets			74,469				75,230
TOTAL ASSETS		$	134,821			$	145,656
CURRENT LIABILITIES
Accounts payable		$	2,537			$	1,810
Other current liabilities			11,202				9,826
Deferred revenues			74				-
Current portion of long-term debt – related party			2,200				1,600
Total current liabilities			16,013				13,236
NON-CURRENT LIABILITIES
Long-term debt, net of debt discount – related party			11,236				11,538
Liabilities for severance pay			442				426
Deferred revenues, net of current portion			669				669
Total non-current liabilities			12,347				12,633
COMMITMENTS AND CONTINGENCIES (NOTE 11)
STOCKHOLDERS’ EQUITY
Common shares (unlimited authorized; no par value) (2018 issued – 64,215,727 2017 - issued 64,078,781)			201,899				201,806
Additional paid-in capital			61,625				60,891
Accumulated other comprehensive (loss) income			(837	)			1,065
Accumulated deficit			(156,226	)			(143,975	)
Total stockholders’ equity			106,461				119,787
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY		$	134,821			$	145,656

 

See accompanying Notes to Condensed Consolidated Financial Statements

 

 

VBI Vaccines Inc. and Subsidiaries

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

(in thousands, except share and per share amounts)

 

		For the Three Months Ended March 31
		2018				2017
Revenues		$	178			$	127
Operating expenses:
Cost of revenue			1,413				1,275
Research and development			6,964				4,654
General and administration			3,425				3,045
Total operating expenses			11,802				8,974
Loss from operations			(11,624	)			(8,847	)
Interest expense, net of interest income of $202 and $12 (including related party – see Note 8)			(539	)			(704	)
Foreign exchange (loss) gain			(88	)			482
Loss before incomes taxes			(12,251	)			(9,069	)
Income tax benefit			-				431
NET LOSS		$	(12,251	)		$	(8,638	)
Net loss per share of common shares, basic and diluted		$	(0.19	)		$	(0.22	)
Weighted-average number of common shares outstanding, basic and diluted			64,179,605				40,026,270
Other comprehensive (loss) income - currency translation adjustments			(1,902	)			126
COMPREHENSIVE LOSS		$	(14,153	)		$	(8,512	)

 

See accompanying Notes to Condensed Consolidated Financial Statements

 

 

VBI Vaccines Inc. and Subsidiaries

 

Condensed Consolidated Statements of Stockholders’ Equity

(Unaudited)

(in thousands, except share amounts)

 

		Number of Common Shares				Share Capital				Additional Paid-in Capital				Accumulated Other Comprehensive Income (Loss) - Currency Translation Adjustments				Accumulated Deficit				Total Stockholders’ Equity
BALANCE AS OF DECEMBER 31, 2017			64,078,781			$	201,806			$	60,891			$	1,065			$	(143,975	)		$	119,787
Stock-based compensation			135,000				88				734												822
Common shares issued on exercise of stock options			1,946				5																5
Net loss																			(12,251	)			(12,251	)
Currency translation adjustments															(1,902	)							(1,902	)
BALANCE AS OF MARCH 31, 2018			64,215,727			$	201,899			$	61,625			$	(837	)		$	(156,226	)		$	106,461

 

See accompanying Notes to Condensed Consolidated Financial Statements

 

 

VBI Vaccines Inc. and Subsidiaries

 

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(in thousands)

 

		For the Three Months Ended March 31
		2018				2017
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss		$	(12,251	)		$	(8,638	)
Adjustments to reconcile net loss to cash used in operating activities:							-
Depreciation and amortization			149				171
Stock-based compensation			822				624
Amortization of debt discount			299				288
Deferred taxes			-				(431	)
Net change in operating working capital items:
(Increase) in accounts receivable			(27	)			(32	)
(Increase) in inventory			(1	)			(78	)
Decrease in prepaid expenses			54				67
(Increase) in other current assets			(106	)			(95	)
(Increase) in other long-term assets			(19	)			(27	)
(Decrease) increase in accounts payable			614				(609	)
(Decrease) increase in deferred revenues			84				(73	)
Increase in other current liabilities			1,804				589
Net cash flows used in operating activities			(8,578	)			(8,244	)
INVESTING ACTIVITIES
Purchase of property and equipment			(1,015	)			(266	)
Net cash flows provided by investing activities			(1,015	)			(266	)
FINANCING ACTIVITIES
Proceeds from issuance of common shares for cash, upon exercise of stock options			5				16
Net cash flows provided by financing activities			5				16
Effect of exchange rates on cash			(12	)			(279	)
CHANGE IN CASH FOR THE PERIOD			(9,600	)			(8,773	)
CASH, BEGINNING OF PERIOD			67,694				32,282
CASH, END OF PERIOD		$	58,094			$	23,509
Supplementary information:
Interest paid – related party		$	474			$	450
Capital expenditures included in other current liabilities			-				76

 

See accompanying Notes to Condensed Consolidated Financial Statements

 

 

VBI Vaccines Inc. and Subsidiaries

 

Notes to Condensed Consolidated Financial Statements

(Unaudited)

(in thousands, except per share amounts)

 

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 Hepatitis B (“HBV”) vaccine for adults, children and newborns, which is approved for use in Israel and 14 other countries. Sci-B-Vac has not yet been approved by the U.S. 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 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 lead programs in human cytomegalovirus (“CMV”), an infection that, while common, can lead to serious complications in babies and people with weak immune systems, and is involved in the progression of glioblastoma multiforme (“GBM”), which is a form of 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 $156,226 as of March 31, 2018 and cash outflows from operating activities of $8,578 for the three months ended March 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, could be a combination of proceeds from the issuance of equity securities, the issuance of additional debt, or 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 condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result should the Company be unable to continue as a going concern.

 

2. SIGNIFICANT ACCOUNTING POLICIES

 

Basis of Presentation and Consolidation

 

The Company’s fiscal year ends on December 31 of each calendar year. The accompanying unaudited condensed consolidated financial statements have been prepared in U.S. dollars (“USD”) and pursuant to the rules and regulations of the United States Securities and Exchange Commission (“SEC”), for interim reporting. Accordingly, certain information and footnote disclosures normally included in the financial statements prepared in accordance with United States of America generally accepted accounting principles (“U.S. GAAP”), have been condensed or omitted pursuant to such rules and regulations. The December 31, 2017 consolidated balance sheet in this document was derived from the audited consolidated financial statements and does not include all of the disclosures required by U.S. GAAP. The condensed consolidated financial statements and notes included in this quarterly report on Form 10-Q (this “Form 10-Q”) should be read in conjunction with the financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 (the “2017 10-K”), as filed with the SEC on February 26, 2018.

 

The condensed consolidated financial statements include the accounts of the Company 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 condensed consolidated financial statements.

 

In the opinion of management, these condensed consolidated financial statements include all adjustments and accruals of a normal and recurring nature necessary to fairly state the results of the periods presented. The results for the periods presented are not necessarily indicative of results to be expected for the full year or for any future periods.

 

 

Reclassification

 

Certain prior year amounts have been reclassified to conform with the current quarter presentation and were not material to our condensed consolidated financial statements.

 

Significant Accounting Policies

 

The significant accounting policies used in the preparation of these condensed consolidated financial statements are disclosed in the 2017 10-K, and there have been no changes to the Company’s significant accounting policies during the three months ended March 31, 2018, other than revenue recognition discussed below.

 

Revenue recognition

 

Revenues consist primarily of product sales of vaccines and research services. We apply the five-step model outlined in Accounting Standards Codification Topic 606, Revenue from Contracts from Customers (ASC 606). Revenue is recognized when control of the promised products or services is transferred to the Company’s customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those products or services (the transaction price). We adopted ASC 606 effective January 1, 2018. As a result, we have changed our accounting for revenue recognition. We applied ASC 606 using the modified retrospective method and there was no material impact to our consolidated financial statements related to the adoption of ASC 606.

 

Foreign currency

 

The functional and reporting currency of the Company is the USD. Each of the Company’s subsidiaries determines its own respective functional currency, and this currency is used to separately measure each entity’s financial position and operating results.

 

Assets and liabilities of foreign operations with a different functional currency from that of the Company are translated at the closing rate at the end of each reporting period. Profit or loss items are translated at average exchange rates for all the relevant periods. All resulting translation differences are recognized as a component of accumulated other comprehensive 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 the condensed consolidated statements of operations.

 

Use of Estimates

 

Preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. We continually evaluate estimates used in the preparation of the condensed consolidated financial statements for reasonableness. Appropriate adjustments, if any, to the estimates used are made prospectively based upon such periodic evaluation. The significant areas of estimation include determining the deferred tax valuation allowance, 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, the inputs in determining the fair value of equity-based awards and warrants issued as well as the values ascribed to assets acquired and liabilities assumed in business combinations. Actual results may differ from estimates made.

 

Goodwill and In-Process Research and Development

 

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), an entity should perform its goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. Under Accounting Standards Update (“ASU”) 2017-04, “Intangibles – Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment”, Step 2 from the goodwill impairment test has been eliminated and goodwill impairment is measured as the excess of the carrying amount of the reporting unit over its fair value. The Company has established August 31^st as the date for its annual impairment test of goodwill.

 

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 $243 for the three-month period ended March 31, 2018.

 

 

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.

 

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 condensed 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 assets approximate their respective fair values.

 

At March 31, 2018 and December 31, 2017, the fair value of our outstanding debt, which is considered level 3 in the fair value hierarchy, is estimated to be approximately $15,306 and $15,157, respectively.

 

 

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, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”). ASU 2014-09 outlines a single comprehensive model to use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance, including industry-specific guidance. ASU 2014-09 also requires entities to disclose sufficient information, both quantitative and qualitative, to enable users of financial statements to understand the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. Our adoption of this ASU effective, January 1, 2018, did not have a material impact on our condensed consolidated financial statements and footnote disclosures.

 

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.

 

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 leases 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. While we continue to evaluate the effect of adopting this guidance on our consolidated financial statements and related disclosures, we expect our operating leases, as disclosed in Note 11, will be subject to the new standard. We will recognize right-of-use assets and operating lease liabilities on our consolidated balance sheets upon adoption, which will increase our total assets and liabilities.

 

 

4. INVENTORY, NET

 

Inventory is stated at the lower of cost or market and consists of the following:

 

		March 31, 2018				December 31, 2017
Finished goods		$	47			$	99
Work-in-process			381				119
Raw materials			355				570
		$	783			$	788

 

5. INTANGIBLES

 

						March 31, 2018
		Gross Carrying Amount				Accumulated Amortization				Cumulative Impairment Charge				Cumulative Currency Translation				Net Book Value
Patents		$	669			$	(414	)		$	-			$	30			$	285
IPR&D assets			61,500				-				(300	)			115				61,315
		$	62,169			$	(414	)		$	(300	)		$	145			$	61,600

 

						December 31, 2017
		Gross Carrying Amount				Accumulated Amortization				Cumulative Impairment Charge				Cumulative Currency Translation				Net Book Value
Patents		$	669			$	(397	)		$	-			$	33			$	305
IPR&D assets			61,500				-				(300	)			1,831				63,031
		$	62,169			$	(397	)		$	(300	)		$	1,864			$	63,336

 

The Company amortizes intangible assets with finite lives on a straight-line basis over their estimated useful lives.

 

Amortization related to the IPR&D assets will not begin amortizing until the Company commercializes its products.

 

6. OTHER CURRENT LIABILITIES

 

Other current liabilities consisted of the following:

 

		March 31, 2018				December 31, 2017
Accrued expenses (including clinical trial accrued expenses)		$	10,033			$	7,921
Payroll and employee-related costs			1,056				1,699
Other current liabilities			113				206
		$	11,202			$	9,826

 

7. 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 remains the same for both calculations due to the fact that when a net loss exists, dilutive shares are not included in the calculation as their effect would be anti-dilutive. These potentially dilutive securities are more fully described in Note 9, Stockholders’ Equity and Additional Paid-in Capital.

 

The following potentially dilutive securities outstanding at March 31, 2018 and 2017 have been excluded from the computation of diluted weighted average shares outstanding, as they would be antidilutive:

 

		March 31, 2018				March 31, 2017
Warrants			2,618,824				2,068,824
Stock options and equity awards			3,960,549				3,120,525
			6,579,373				5,189,349

 

 

8. LONG-TERM DEBT – RELATED PARTY

 

As at March 31, 2018 and the December 31, 2017, the long-term debt is as follows:

 

		March 31, 2018				December 31, 2017
Long-term debt, net of debt discount		$	13,436			$	13,138
Less: current portion			2,200				1,600
		$	11,236			$	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 Facility”) and raised $13,200 which was combined with the remaining balance from the Facility of $1,800. The total principal outstanding at March 31, 2018, including the $300 exit fee discussed below, is $15,300. Borrowings under the Amended Facility are secured by all of VBI assets. The principal on the Amended Facility accrues interest at an annual rate equal to the greater of (a) one-month LIBOR (subject to a 5.00% cap) or (b) 1.00%, plus the Applicable Margin. The Applicable Margin will be 11.00%. The first eighteen months are interest only. The interest rate as of March 31, 2018 was 12.88%. 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 matures December 6, 2019 and includes both financial and non-financial covenants, including a minimum cash balance requirement. The Company was in compliance with these covenants as of March 31, 2018. Pursuant to the Amended Facility, the Company agreed to appoint a representative of Perceptive Credit on our board of directors (the “Board”) who is also a portfolio manager of the Company’s largest shareholder, effective January 2018, Perceptive Credit’s representative resigned from our Board.

 

The Company’s obligations under the Amended Facility are secured on a senior basis by a lien on substantially all of the assets of the Company and its U.S. and Canadian subsidiaries and guaranteed by the Company and its U.S. and Canadian subsidiaries. The Amended and Restated Credit Agreement also contains customary events of default.

 

The total debt discount of $3,453 is being charged to interest expense using the effective interest method over the term of the debt. As of March 31, 2018, and December 31, 2017, the unamortized debt discount is $1,864 and $2,163. The Company recorded $299 and $288 of interest expense related to the amortization of the debt discount during the three months ended March 31, 2018 and 2017, respectively.

 

Total related party interest expense, including the amortization of the debt discount, was $773 and $738 for the three months ended March 31, 2018 and 2017, respectively. Such amounts are included in Interest expense, net in the accompanying condensed consolidated statements of operations and comprehensive loss.

 

The following table summarizes the future principal payments that the Company expects to make for long-term debt:

 

				Principal payments on Amended Facility and exit fee
	Remaining 2018			$	1,600
	2019				13,700
				$	15,300

 

 

9. STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL

 

Stock option plans

 

The Company’s stock option plans are approved by and administered by the Company’s Board and its Compensation Committee. The Board designates, in connection with recommendations from the Compensation Committee, eligible participants to be included under the plan, and designates the number of options, exercise price and vesting period of the new options.

 

2006 VBI US Stock Option Plan

 

No further options will be issued under the 2006 VBI US Stock Option Plan (the “2006 Plan”). As at March 31, 2018, there were 1,140,053 options outstanding under the 2006 Plan.

 

2013 Stock Incentive Plan

 

No further options will be issued under the 2013 Equity Incentive Plan (the “2013 Plan”). As at March 31, 2018, there were 4,613 options outstanding under the 2013 Plan.

 

2014 Equity Incentive Plan

 

No further options will be issued under the 2014 Equity Incentive Plan (the “2014 Plan”). As at March 31, 2018, there were 645,222 options outstanding under the 2014 Plan.

 

2016 VBI Equity Incentive Plan

 

The 2016 VBI Equity Incentive Plan (the “2016 Plan”) is a rolling incentive plan that sets the number of common shares issuable under the 2016 Plan, together with any other security-based compensation arrangement of the Company, at a maximum of 10% of the aggregate common shares issued and outstanding on a non-diluted basis at the time of any grant under the 2016 Plan. The 10% maximum is inclusive of options granted under all equity incentive plans. The 2016 Plan is an omnibus equity incentive plan pursuant to which the Company may grant equity and equity-linked awards to eligible participants in order to promote the success of the Company following the VBI-SciVac Merger by providing a means to offer incentives and to attract, motivate, retain and reward persons eligible to participate in the 2016 Plan. Grants under the 2016 Plan include a grant or right consisting of one or more options, stock appreciation rights (“SARs”), restricted share units (“RSUs”), performance share units (“PSUs”), shares of restricted stock or other such award as may be permitted under the 2016 Plan. As at March 31, 2018, there were 1,639,114 options and 531,547 stock awards outstanding under the 2016 Plan.

 

The aggregate number of common shares remaining available for issuance for awards under this plan total 1,936,496 at March 31, 2018.

 

 

Activity related to stock options is as follows:

 

		Number of Stock Options				Weighted Average Exercise Price
Balance outstanding at December 31, 2017			2,351,395			$	4.44
Granted			1,265,000			$	4.19
Forfeited			(185,447	)			4.00
Exercised			(1,946	)		$	2.50
Balance outstanding at March 31, 2018			3,429,002			$	4.35
Exercisable at March 31, 2018			1,747,927			$	4.50

 

Information relating to restricted stock units is as follow:

 

		Number of Stock Awards				Weighted Average Fair Value at Grant Date
Unvested shares outstanding at December 31, 2017			424,379			$	3.99
Granted			150,000			$	4.26
Vested and exercised			(17,832	)		$	4.94
Forfeited			(25,000	)		$	3.87
Unvested shares outstanding at March 31, 2018			531,547			$	4.03

 

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			114.53	%			87.22	%
Risk free interest rate			2.48	%			2.31	%
Expected term in years			5.77				6.3
Expected dividend yield			0	%			0	%
Weighted average fair value per option		$	3.53			$	3.12

 

The fair value of the options is recognized as an expense on a straight-line basis over the vesting period and forfeitures are accounted for when they occur. The total stock-based compensation expense recorded in the three months ended March 31, 2018 and 2017 was as follows:

 

		Three months ended March 31
		2018				2017
Research and development		$	191			$	185
General and administrative			618				423
Cost of revenues			13				16
Total stock-based compensation expense		$	822			$	624

 

 

10. INCOME TAXES

 

The Company operates in U.S., Israel and Canadian tax jurisdictions. Its income is subject to varying rates of tax, and losses incurred in one jurisdiction cannot be used to offset income taxes payable in another.

 

The Company determines its annual effective tax rate at the end of each interim period based on the year to date period results. Since the Company is incorporated in Canada, it is required to use Canada’s statutory tax rate of 26.00% in the determination of the estimated annual effective tax rate.

 

The Company’s effective tax rate on loss before tax for the three months ended March 31, 2018 of 0% (4.78% - 2017) differs from the Canadian statutory rate of 26.00% primarily due to recording a valuation allowance on the Canadian deferred tax assets in excess of the remaining Canadian deferred tax liability and the effect of recording a valuation allowance against deferred tax assets in all other jurisdictions.

 

The Company maintains a valuation allowance on all of its deferred tax assets. A valuation allowance is required when, based upon an assessment of various factors, including recent operating loss history, anticipated future earnings, and prudent and reasonable tax planning strategies, it is more likely than not that some portion of the deferred tax assets will not be realized.

 

11. COMMITMENTS AND CONTINGENCIES

 

Legal Proceedings

 

From time to time, the Company may be involved in certain claims and litigation arising out of the ordinary course of business. Management assesses such claims and, if it considers that it is probable that an asset had been impaired or a liability had been incurred and the amount of loss can be reasonably estimated, provisions for loss are made based on management’s assessment of the most likely outcome. As at March 31, 2018 the Company believes that it maintains adequate insurance coverage for any such litigation matters arising in the normal course of business.

 

Operating Leases

 

The Company has entered into various non-cancelable lease agreements for its office, lab and manufacturing facilities. These arrangements expire at various times through 2022. Rent expense for the three months ended March 31, 2018 and 2017 was $216 and $217, respectively.

 

The future annual minimum payments under these leases is as follows:

 

Year ending December 31
Remaining 2018		$	836
2019			913
2020			527
2021			451
2022			38
Thereafter			-
Total		$	2,765

 

On February 28, 2018 VBI DE signed a two-year term extension, which included additional office space, related to the office space in Cambridge, MA committing it to approximately $461 of rent payments which has been included in the above table.

 

 

12. 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:

 

		Three Months Ended March 31
		2018				2017
Israel		$	106			$	111
Asia			30				14
South America			-				2
Europe			42				-
Total		$	178			$	127

 

There was no revenue attributed to our country of domicile, Canada, for the three months ended March 31, 2018 and 2017.

 

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

You should read the following discussion of our financial condition and results of operations in conjunction with the consolidated financial statements and the related notes included elsewhere in this Form 10-Q and with our audited consolidated financial statements included in our annual report on Form 10-K for the year ended December 31, 2017, as filed with the U.S. Securities and Exchange Commission (the “SEC”).

 

Except for per share amounts or as otherwise specified to be in millions, amounts presented are stated in thousands.

 

Overview

 

We are 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 hepatitis B vaccine, which is approved for use in Israel and 14 other countries. Sci-B-Vac, has not yet been approved by the FDA, EMA or Heath Canada. The Sci-B-Vac vaccine has demonstrated safety and efficacy in nearly 500,000 patients in currently licensed markets. Several clinical trials have shown rapid and high rates of seroprotection with Sci-B-Vac. The Phase IV clinical study, conducted in Israel in order to qualify a new in-house reference standard for regulatory and quality control purposes, was successfully completed. We are currently enrolling patients in a pivotal Phase III clinical program, the results of which are intended to support regulatory and marketing authorization application submissions to obtain FDA, EMA, and Health Canada market approvals for commercial sale of Sci-B-Vac in the U.S., Europe, and Canada respectively. Our wholly-owned subsidiary in Rehovot, Israel currently manufactures and sells Sci-B-Vac.

 

We are also advancing a pipeline of enveloped virus-like particle (“eVLP”) vaccines, developed with our eVLP platform technology that allows for the design of enveloped virus-like particles that closely mimic the target viruses. We have lead programs in both infectious disease, with our congenital cytomegalovirus (“CMV”) vaccine candidate, and in immuno-oncology, with our glioblastoma multiforme (“GBM”) vaccine candidate. CMV is an infection that, while common, can lead to serious complications in babies and people with weak immune systems. In September 2016, we completed the enrollment and initial dosing of 128 participants in the Phase I clinical study to evaluate its preventative CMV vaccine candidate. In July 2017, we announced interim data from the Phase I clinical study of safety data through day 84 of the study and initial immunogenicity signals in participant samples collected one month after the second of three planned vaccine doses. Final data read out is anticipated mid-year 2018. In January 2018, VBI initiated dosing of its GBM candidate in a Phase I/IIa clinical program. We expect immunologic data from ongoing biomarker analyses mid-year 2018 and initial correlations between biomarker analyses and clinical outcomes in the second half of 2018, with 6-month overall survival and progression-free survival expected in the first half of 2019.

 

We may also seek to in-license clinical-stage vaccines that we believe complement our product and pipeline portfolio, in addition to technologies that may supplement our therapeutic vaccination efforts in immuno-oncology.

 

At present, our operations are focused on:

 

	●	conducting the Sci-B-Vac Phase III clinical program to support various marketing authorization applications in the U.S., Europe, Canada;
	●	completing the Phase I clinical study for our CMV vaccine candidate, VBI-1501;
	●	conducting the planned Phase I/IIa clinical study of our GBM vaccine candidate, VBI-1901;
	●	manufacturing in Rehovot, Israel and sale of Sci-B-Vac in territories where it is currently registered;
	●	scaling-up Sci-B-Vac manufacturing capabilities to further commercialize this product in additional markets where we may obtain regulatory approval;
	●	continuing the research and development of our product candidates, including the exploration and development of new product candidates, including a Zika vaccine candidate;
	●	operational, financial and management information systems and human resources support, including additional personnel to support our vaccine development and commercialization activities; and
	●	maintaining, expanding and protecting our intellectual property portfolio.

 

VBI’s income generating activities have been the sale of Sci-B-Vac product in markets where it is approved, though those markets have generated a limited number of sales to-date and R&D services generating fees. VBI has incurred significant net losses and negative operating cash flows since inception and expect to continue incurring losses and negative cash flows from operations as we carry out our, planned clinical, regulatory, R&D, sales and manufacturing activities with respect to the advancement of our Sci-B-Vac and new vaccine candidates. As of March 31, 2018, VBI had an accumulated deficit of approximately $156.2 million and stockholders’ equity of approximately $106.5 million. Our ability to maintain our status as an operating company is dependent upon obtaining adequate cash to finance our clinical development, manufacturing, our administrative overhead and our research and development activities. We plan to finance future operations with existing cash reserves. We expect that we will need to secure additional financing to finance our business plans, if required, which may be a combination of proceeds from the issuance of equity securities, the issuance of additional debt, and revenues from potential collaborations, if any. There is no assurance the Company will manage to obtain these sources of financing, if required. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying financial statements have been prepared assuming that we will continue as a going concern. The 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 we be unable to continue as a going concern.

 

 

We have incurred operating losses since inception, have not generated significant product sales revenue and have not achieved profitable operations. We incurred net losses of $12.3 million for the three months ended March 31, 2018 and we expect to continue to incur substantial losses in future periods. We anticipate that our operating expenses will increase substantially as we continue our clinical studies. These include expenses related to:

 

	●	continuing the Phase III clinical program for Sci-B-Vac and the Phase I/IIa clinical study of our GBM vaccine candidate;
	●	continuing the research and development of our product candidates;
	●	scaling-up manufacturing capabilities, both at Rehovot and through sub-contractors to commercialize products and dose forms for which we may obtain regulatory approval;
	●	maintaining, expanding and protecting our intellectual property portfolio;
	●	hiring additional clinical, manufacturing, and scientific personnel or contractors; and
	●	operational, financial and management information systems and human resources support, including additional personnel, to support our vaccine development.

 

In addition, we have incurred and will continue to incur significant expenses as a public company, which subjects us to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act and the rules and regulations of the NASDAQ Capital Market and the Canadian securities regulators. Effective as of March 23, 2018, we voluntarily delisted our common shares from the Toronto Stock Exchange.

 

In 2017, we raised $71.9 million from equity financings to support our Sci-B-Vac, CMV, and GBM vaccine programs, to continue the advancement of our research programs, and for use in other general corporate purposes. Based upon our current cash position and by monitoring our discretionary expenditures as well as the management of our clinical trial commitments and operating costs, we believe these proceeds will be sufficient to fund our activities, including our approved capital expenditure requirements throughout 2018. We expect, however, that additional financing will be needed in the future to further support clinical, regulatory, research and development, sales and manufacturing, and general business operations.

 

Since inception, VBI and its subsidiaries collectively have raised approximately $196.6 million in total equity and debt financing to support clinical and research development and general business operations.

 

Research and Development (“R&D”) Services

 

Pursuant to an agreement with the Israel Innovations Authority (formerly the Office of the Chief Scientist of Israel), the Company is required to make services available for the biotechnology industry in Israel. These services include relevant activities for development and manufacturing of therapeutic proteins according to international standards and GMP quality level suitable for toxicological studies in animals and clinical studies (Phase I & II) in humans. Service activities include analytics/bio analytics methods for development and process development of therapeutic proteins starting with a lead candidate clone through the upstream, purification, formulation and filling processes and manufacturing for Phase I & II clinical trials.

 

These R&D services are primarily marketed to the Israeli research community in academia and Israeli biotechnology companies in the life sciences lacking the infrastructure or experience in the development and production of therapeutic proteins in the standards and quality required for clinical trials for human use. In 2017 the Company provided services to more than 10 biotechnology companies including analytical development, upstream development process, protein purification and formulation and filling for Phase I clinical studies.

 

 

Financial Overview

 

Overall Performance

 

The Company had net losses of approximately $12,251 and $8,638 for the three months ended March 31, 2018 and 2017, respectively. The Company has an accumulated deficit of $156,226 at March 31, 2018. The Company had $58,094 of cash at March 31, 2018 and net working capital of approximately $44,339.

 

Cost of revenues

 

Cost of revenues consist primarily of costs incurred for manufacturing the Sci-B-Vac vaccine, which includes cost of materials, consumables, supplies, contractors and manufacturing salaries.

 

Research and Development Expenses

 

R&D expenses consist primarily of costs incurred for the development of our CMV, GBM, and Sci-B-Vac vaccines, which include:

 

	●	the cost of acquiring, developing and manufacturing clinical study materials and other consumables and lab supplies used in our pre-clinical studies;
	●	expenses incurred under agreements with contractors or Contract Manufacturing Organizations to advance the vaccines into and through completion of clinical studies; and
	●	employee-related expenses, including salaries, benefits, travel and stock-based compensation expense.

 

We expense R&D costs when we incur them.

 

General and Administrative Expenses

 

General and administration expenses consist principally of salaries and related costs for executive and other administrative personnel and consultants, including stock-based compensation and travel expenses. Other general and administration expenses include professional fees for legal, patent protection, consulting and accounting services, travel and conference fees, including board and scientific advisory board meeting costs, rent, maintenance of facilities, depreciation, office supplies and expenses, insurance and other general expenses. General and administrative expenses are expensed when incurred.

 

We expect that our general and administration expenses will increase in the future as a result of adding employees and scaling our operations commensurate with advancing clinical candidates and continuing to support a public company infrastructure. These increases will likely include increased costs for insurance, hiring of additional personnel, board committees, outside consultants, investor relations, lawyers and accountants, among other expenses.

 

Interest Income

 

Interest income consists principally of interest income earned on cash balances.

 

Interest Expense

 

Interest expense is associated with our credit facility entered into on July 25, 2014 and subsequently amended on December 6, 2016.

 

 

Results of Operations

 

Three Months Ended March 31, 2018 Compared to the Three Months Ended March 31, 2017

 

All dollar amounts stated below are in thousands, unless otherwise indicated.

 

		Three months ending March 31
		2018				2017				Change $				Change %
Revenue		$	178			$	127			$	51				40	%
Expenses:
Cost of revenue			1,413				1,275				138				11	%
Research and development			6,964				4,654				2,310				50	%
General and administration			3,425				3,045				380				12	%
Total operating expenses			11,802				8,974				2,828				32	%
Net loss from operations			(11,624	)			(8,847	)			(2,777	)			31	%
Interest expenses, net			(539	)			(704	)			165				(23	)%
Foreign exchange (loss) gain			(88	)			482				(570	)			(118	)%
Loss before income taxes			(12,251	)			(9,069	)			(3,182	)			35	%
Income tax benefit			-				431				(431	)			(100	)%
NET LOSS		$	(12,251	)		$	(8,638	)		$	(3,613	)			42	%

 

Revenues

 

Revenue for the three months ended March 31, 2018 was $178, as compared to $127 for the three months ended March 31, 2017.

 

Revenue by Geographic Region

 

		Three months ending March 31
		2018				2017				$ Change				% Change
		$				$
Revenue in Israel		$	106			$	111			$	(5	)			(5	)%
Revenue in Asia			30				14				16				114	%
Revenue in South America			-				2				(2	)			(100	)%
Revenue in Europe			42				-				42				100	%
Total Revenue		$	178			$	127				51				40	%

 

Revenue earned in Israel, Asia, South America and Europe for the three months ended March 31, 2018 and 2017 were insignificant.

 

Cost of Revenues

 

Cost of revenues for the three months ended March 31, 2018 was $1,413 as compared to $1,275 for the three months ended March 31, 2017. The increase in the cost of revenues of $138, or 11%, was a result of slightly increased revenue as well as increased headcount and salary increases.

 

Research and Development

 

R&D expenses for the three months ended March 31, 2018 were $6,964 as compared to $4,654 for the three months ended March 31, 2017. During the three months ended March 31, 2018, the significant increase in the cost of R&D is as a result of the increased costs related to the ongoing clinical studies of Sci-B-Vac, which commenced patient dosing in December 2017 and our GBM vaccine candidate, which commenced patient dosing in January 2018. This is compared to the three months ended March 31, 2017 where only the CMV clinical study was ongoing, which commenced patient dosing in June 2016 with the last visit in August 2017.

 

General and Administrative

 

General and administrative (“G&A”) expenses for the three months ended March 31, 2018 were $3,425 as compared to $3,045 for the three months ended March 31, 2017. The G&A expense increase of $380, or 12%, is a result of increased headcount and stock-based compensation expenses.

 

 

Net Loss from Operations

 

The net loss from operations for the three months ended March 31, 2018 were $11,624 as compared to $8,847 for the three months ended March 31, 2017. The $2,777 increase in the net loss from operations resulted from the increased cost of revenues, R&D expenses, and G&A expenses, discussed above.

 

Interest Expense, net

 

The interest expense decrease of $165 is largely a result of interest income of $202 earned on cash balances for the three months ended March 31 2018 as compared to minimal interest for the three months ended March 31, 2017. Interest paid on the long-term debt and non-cash accretion related to the debt discount were comparable for the three months ended March 31, 2018 and March 31, 2017.

 

Foreign Exchange Gain

 

The foreign exchange loss of $88 for the three months ended March 31, 2018 as compared to a gain of $482 in the comparative period for 2017, is the result of the fluctuation in the foreign currency exchange rate of the CAD and the NIS as compared to the U.S. dollar.

 

Net Loss

 

The net loss increased by $3,613, or 42%, from $8,638 for the three months ended March 31, 2017 to $12,251 for the three months ended March 31, 2018. The increase in our net loss is mainly attributable to the increase in our loss from operations as discussed above.

 

Liquidity and Capital Resources

 

		March 31, 2018				December 31, 2017				$ Change				% Change
Cash		$	58,094			$	67,694			$	(9,600	)			(14	)%
Current Assets			60,352				70,426				(10,074	)			(14	)%
Current Liabilities			16,013				13,236				2,777				21	%
Working Capital			44,339				57,190				(12,851	)			(22	)%
Accumulated Deficit		$	(156,226	)		$	(143,975	)			(12,251	)			9	%

 

As at March 31, 2018, we had cash of $58,094 as compared to $67,694 as at December 31, 2017. As at March 31, 2018, the Company had working capital of $44,339 as compared to working capital of $57,190 at December 31, 2017. Working capital is calculated by subtracting current liabilities from current assets.

 

We expect that we will need to secure additional financing in the future to further support clinical, regulatory, research and development, sales and manufacturing and general business operations. We base this belief on assumptions that are subject to change, and we may be required to use our available cash resources sooner than we currently expect. The Company expects a need to raise additional funds in order to continue its ongoing development programs. The additional funds may be in the form of additional debt, equity or a combination of both and may require that additional warrants be issued. To date, the Company has been able to obtain financing as and when it was needed; however, there is no assurance that financing will be available in the future, or if it is, that it will be available at acceptable terms.

 

The report of our independent registered public accounting firm on our consolidated financial statements for the year ended December 31, 2017 contains an explanatory paragraph regarding our ability to continue as a going concern. The accompanying financial statements have been prepared assuming that the Company will continue as a going concern; however, the above conditions raise substantial doubt about the Company’s ability to do so. The 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. The Company’s long-term success and ability to continue as a going concern is dependent upon obtaining sufficient capital to fund the research and development of its products, to bring about their successful commercial release, to generate revenue and, ultimately, to attain profitable operations or, alternatively, to advance its products and technology to such a point that they would be attractive candidates for acquisition by others in the industry.

 

On October 30, 2017, we 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. We have and will continue to use the proceeds of the underwritten public offering to support our Sci-B-Vac, CMV, and GBM vaccine program, to continue the advancement of our research programs and for other general corporate purposes.

 

 

Our actual future capital requirements will depend on many factors, including the progress and results of our clinical trials, the duration and cost of discovery and preclinical development, laboratory testing and clinical trials for our products, the timing and outcome of regulatory review of our products, product sales outside of Israel, the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims and other intellectual property rights, the number and development requirements of other product candidates that we pursue and the costs of commercialization activities, including product marketing, sales and distribution.

 

The Company will require additional funds to conduct clinical and non-clinical trials, achieve regulatory approvals, and, subject to such approvals, commercially launch its products.

 

We expect to finance our future cash needs through public or private equity offerings, debt financings, or corporate collaboration and licensing arrangements. Although we are pursuing different opportunities, other than as disclosed in this report, we currently do not have any signed commitments for future external funding. We may need to raise additional funds more quickly if one or more of our assumptions prove to be incorrect or if we choose to expand our product development efforts more rapidly than we presently anticipate. We may also decide to raise additional funds even before we need them if the conditions for raising capital are favorable. Additional equity or debt financing, grants or corporate collaboration and licensing arrangements may not be available on acceptable terms, if at all. If adequate funds are not available, we may be required to delay, reduce the scope of or eliminate our R&D programs, reduce our planned commercialization efforts or obtain funds through arrangements with collaborators or others that may require us to relinquish rights to certain product candidates that we might otherwise seek to develop or commercialize independently.

 

To the extent we raise additional capital by issuing equity securities or obtaining borrowings convertible into equity, ownership dilution to existing stockholders will result and future investors may be granted rights superior to those of existing stockholders. The incurrence of indebtedness or debt financing would result in increased fixed obligations and could also result in covenants that would restrict our operations. Our ability to obtain additional capital may depend on prevailing economic conditions and financial, business and other factors beyond our control. The unstable economic environment in Europe, and disruptions in the U.S. and global financial markets may adversely impact the availability and cost of credit, as well as our ability to raise money in the capital markets. Current economic conditions have been, and continue to be volatile. Continued instability in these market conditions may limit our ability to access the capital necessary to fund and grow our business.

 

Net cash used by Operating Activities

 

The Company incurred net losses of $12,251 and $8,638 in the three months ended March 31, 2018 and 2017, respectively. The Company used $8,578 and $8,244 in cash for operating activities during the three months ended March 31, 2018 and 2017, respectively. The increase in cash outflows is largely as a result of increased net losses related to the increased R&D expenses offset by an increase in net changes in working capital items, specifically accounts payable and other current liabilities.

 

 

Net cash used by Investing Activities

 

Cash flows used in investing activities increased by $749, from $266 for the three months ended March 31, 2017 to $1,015 for the three months ended March 31, 2018. The increase was largely related to the purchase of additional property and equipment in SciVac. As part of scaling up of our manufacturing capabilities, we were, and are continued to be, required to purchase additional manufacturing equipment and information technology equipment.

 

Net cash received from Financing Activities

 

Cash flows related to financing activities were not significant in three months ended March 31, 2017 and 2018.

 

The Company’s long-term success and ability to continue as a going concern is dependent upon obtaining sufficient capital to fund the research and development of its products, to bring about their successful commercial release, to generate revenue and, ultimately, to attain profitable operations or, alternatively, to advance its products and technology to such a point that they would be attractive candidates for acquisition by others in the industry.

 

To date, the Company has been able to obtain financing as and when it was needed; however, there is no assurance that financing will be available in the future, or if it is, that it will be available at acceptable terms.

 

Off-Balance Sheet Arrangements

 

As of March 31, 2018, the Company has no off-balance sheet transactions, arrangements, obligations (including contingent obligations), or other relationships with unconsolidated entities or other persons that have, or may have, a material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

 

Tabular Disclosure of Contractual Obligations

 

The tabular disclosure of contractual obligations is disclosed in the 2017 10-K and there have been no material changes during the three months ended March 31, 2018, other than disclosed in Note 11 of the Notes to the Condensed Consolidated Financial Statements.

 

Critical Accounting Policies and Estimates

 

There have been no changes to our critical accounting policies during the three months ended March 31, 2018. Critical accounting policies and the significant accounting estimates made in accordance with such policies are regularly discussed with the Audit Committee of the Company’s board of directors. Those policies are discussed under “Critical Accounting Policies” in our “Management’s Discussion and Analysis of the Financial Condition and Results of Operations” included in Item 7, as well as in our consolidated financial statements and the footnotes thereto, included in our 2017 10-K.

 

Trends, Events and Uncertainties

 

As with other companies that are in the process of commercializing novel vaccines, we will need to successfully manage normal business and scientific risks. Research and development of new technologies is, by its nature, unpredictable. We cannot assure you that our technology will be adopted, that we will ever earn revenues sufficient to support our operations, or that we will ever be profitable. Furthermore, other than as discussed in this report, we have no committed source of financing and may not be able to raise money as and when we need it to continue our operations. If we cannot raise funds as and when we need them, we may be required to severely curtail, or even to cease, our operations.

 

 

Other than as discussed above and elsewhere in this Form 10-Q, we are not aware of any trends, events or uncertainties that are likely to have a material effect on our financial condition.

 

Recent Accounting Pronouncements

 

See Note 3 of Notes to the Condensed Consolidated Financial Statements.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

The quantitative and qualitative disclosures about market risk are disclosed in the 2017 10-K and there have been no material changes during the three months ended March 31, 2018.

 

Item 4. Controls and Procedures

 

Disclosure Controls and Procedures

 

Our management has evaluated, under the supervision and with the participation of our Chief Executive Officer (our principal executive officer) and our Senior Vice-President, Finance (our principal financial officer), the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Form 10-Q as defined in Rule 13a-15(e) or Rule 15d-15(e) under the Exchange Act. Based on that evaluation, our Chief Executive Officer and our Senior Vice-President, Finance have concluded that, as of the end of the period covered by this Form 10-Q, our disclosure controls and procedures are effective in ensuring that information required to be disclosed in our Exchange Act reports is (1) recorded, processed, summarized and reported in a timely manner, and (2) accumulated and communicated to our management, including our Chief Executive Officer and our Senior Vice-President, Finance, as appropriate, to allow timely decisions regarding required disclosure.

 

Changes in Internal Control Over Financial Reporting

 

During the three months ended March 31, 2018, we began implementation of a new enterprise resource planning (“ERP”) system to support our procurement and financial reporting processes. We implemented this new ERP system to enhance our overall system of internal control over financial reporting through further automation and integration of business processes. The ERP system was not implemented in response to any identified deficiency or material weakness in our internal control over financial reporting. As a result of this implementation, we have modified the design and documentation of certain internal control processes and procedures relating to the ERP system. We will continue to implement modules of the ERP system through 2018 relating mainly to inventory, manufacturing and quality processes.

 

Other than the ERP system implementation described above, there were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the fiscal quarter ended March 31 2018 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

 

PART II—OTHER INFORMATION

 

Item 1. 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.

 

Item 1A. Risk Factors

 

A description of the risks associated with our business, financial condition and results of operations is set forth in “Item 1A. Risk Factors” of our annual report on Form 10-K for the fiscal year ended December 31, 2017, as filed with the SEC on February 26, 2018. There have been no material changes to these risks during the three months ended March 31, 2018.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

a) Sales of Unregistered Securities

 

There have been no unregistered sales of securities during the period covered by this Form 10-Q that have not been previously reported in a current report on Form 8-K. The Company has not made any purchases of its own securities during the time period covered by this Form 10-Q.

 

c) Issuer Purchases of Equity Securities

 

None.

 

Item 3. Defaults Upon Senior Securities

 

None.

 

Item 4. Mine Safety Disclosure

 

Not applicable.

 

Item 5. Other Information

 

The information set forth below is included herein for the purpose of providing the disclosure required under “Item 1.01 - Entry into a Material Definitive Agreement” of Form 8-K  .

 

Item 6. Exhibits

 

See the Exhibit Index following the signature page to this Form 10-Q for a list of exhibits filed or furnished with this Form 10-Q, which Exhibit Index is incorporated herein by reference.

 

 

EXHIBIT INDEX

 

Exhibit No.		Description
3.1		Articles (incorporated by reference to Exhibit 3.1 to the registration statement on Form F-4 (SEC File No. 333-208761), filed with the SEC on December 23, 2015).
3.2		Notice of Articles (incorporated by reference to Exhibit 3.2 to Amendment No. 1 to the registration statement on Form F-4 (SEC File No. 333-208761), filed with the SEC on February 5, 2016).
3.3		Form of Notice of Alteration (incorporated by reference to Exhibit 3.3 to Amendment No. 1 to the registration statement on Form F-4 (SEC File No. 333-208761), filed with the SEC on February 5, 2016).
10.1+		Amendment to Consulting Agreement with F. Diaz-Mitoma Professional Corporation, dated February 19, 2018 (incorporated by reference to Exhibit 10.57 to the annual report on Form 10-K (SEC File No. 001-37769), filed with the SEC on February 26, 2018).
10.2		Amendment to Sublease Lease, dated January 21, 2018, by and between Green Power YE and SciVac Ltd. (incorporated by reference to Exhibit 10.58 to the annual report on Form 10-K (SEC File No. 001-37769), filed with the SEC on February 26, 2018).
10.3		Waiver Agreement, dated February 21, 2018, by and among Variation Biotechnologies (US), Inc., the Guarantors party thereto, and Perceptive Credit Holdings, LP (incorporated by reference to Exhibit 10.59 to the current report on Form 8-K (SEC File No. 001-37769), filed with the SEC on February 26, 2018.
10.4*		Amendment to lease agreement among American Twine Limited Partnership and Variation Biotechnologies (US), Inc.
31.1*		Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934.
31.2*		Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934.
32.1**		Certification of Chief Executive Officer pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350.
32.2**		Certification of Chief Financial Officer pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350.

 

101.INS*		XBRL Instance Document.
101.SCH*		XBRL Taxonomy Extension Schema Document.
101.CAL*		XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF*		XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB*		XBRL Taxonomy Extension Labels Linkbase Document.
101.PRE*		XBRL Taxonomy Extension Presentation Linkbase Document.

 

* Filed herewith.

 

** Furnished herewith.

 

+ Indicates a management contract or compensatory plan.

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

Date: May 1, 2018	VBI VACCINES INC.
	By:	/s/ Jeff Baxter
		Jeff Baxter President & Chief Executive Officer (Principal Executive Officer)
	By:	/s/ Athena Kartsaklis
		Athena Kartsaklis
		Senior Vice-President, Finance (Principal Financial and Accounting Officer)