2017-09-30 10Q Q3

0000926617-17-000068.txt : 20171108 0000926617-17-000068.hdr.sgml : 20171108 20171108161350 ACCESSION NUMBER: 0000926617-17-000068 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 34 CONFORMED PERIOD OF REPORT: 20170930 FILED AS OF DATE: 20171108 DATE AS OF CHANGE: 20171108 FILER: COMPANY DATA: COMPANY CONFORMED NAME: VERMILLION, INC. CENTRAL INDEX KEY: 0000926617 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 330595156 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-34810 FILM NUMBER: 171186765 BUSINESS ADDRESS: STREET 1: 12117 BEE CAVES ROAD BUILDING THREE STREET 2: SUITE 100 CITY: AUSTIN STATE: TX ZIP: 78738 BUSINESS PHONE: 512-519-0400 MAIL ADDRESS: STREET 1: 12117 BEE CAVES ROAD BUILDING THREE STREET 2: SUITE 100 CITY: AUSTIN STATE: TX ZIP: 78738 FORMER COMPANY: FORMER CONFORMED NAME: CIPHERGEN BIOSYSTEMS INC DATE OF NAME CHANGE: 20000316 FORMER COMPANY: FORMER CONFORMED NAME: ABIOTIC SYSTEMS DATE OF NAME CHANGE: 19950407 10-Q 1 vrml-20170930x10q.htm 10-Q 2017-09-30 10Q Q3

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)

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

For the quarterly period ended September 30, 2017

☐ 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: 001-34810

Vermillion, Inc.

(Exact Name of Registrant as Specified in Its Charter)


Delaware		33-0595156
(State or Other Jurisdiction of Incorporation or Organization)		(I.R.S. Employer Identification No.)
12117 Bee Caves Road, Building Three, Suite 100, Austin, Texas		78738
(Address of Principal Executive Offices)		(Zip Code)

(512) 519-0400

(Registrant’s Telephone Number, Including Area Code)

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 ☑ 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 ☑ No ☐

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


Large accelerated filer ☐	Accelerated filer ☐

Non-accelerated filer ☐	Smaller reporting company ☑ Emerging growth company ☐

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. ☐

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

Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☑ No ☐

As of October 31, 2017, the registrant had 59,998,748 shares of common stock, par value $0.001 per share, outstanding.

VERMILLION, INC.

FORM 10-Q

Table of Contents


		Page
PART I	Financial Information	4
Item 1	Financial Statements	4
	Condensed Consolidated Balance Sheets as of September 30, 2017 and December 31, 2016 (unaudited)	4
	Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2017 and 2016 (unaudited)	6
	Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2017 and 2016 (unaudited)	7
	Notes to Condensed Consolidated Financial Statements (unaudited)	8
Item 2	Management's Discussion and Analysis of Financial Condition and Results of Operations	15
Item 3	Quantitative and Qualitative Disclosures About Market Risk	26
Item 4	Controls and Procedures	26
PART II	Other Information	27
Item 1	Legal Proceedings	27
Item 1A	Risk Factors	27
Item 6	Exhibits	28
SIGNATURES		29

Vermillion, OVA1 and Overa are registered trademarks of Vermillion, Inc.

PART I - FINANCIAL INFORMATION

ITEM 1.FINANCIAL STATEMENTS

Vermillion, Inc.

Condensed Consolidated Balance Sheets

(Amounts in Thousands, Except Share and Par Value Amounts)

(Unaudited)


	September 30,		December 31,
	2017		2016
Assets
Current assets:
Cash and cash equivalents	$	7,752	$	5,242
Accounts receivable		221		275
Prepaid expenses and other current assets		175		498
Inventories		155		93
Total current assets		8,303		6,108
Property and equipment, net		1,364		1,911
Other assets		11		-
Total assets	$	9,678	$	8,019

Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	514	$	881
Accrued liabilities		1,430		1,464
Deferred Revenue		62		-
Short-term debt		191		182
Other current liabilities		32		34
Total current liabilities		2,229		2,561
Non-current liabilities:
Long-term debt		1,528		1,667
Other non-current liabilities		-		29
Total liabilities		3,757		4,257
Commitments and contingencies (Note 3)
Stockholders’ equity:
Common stock, par value $0.001 per share, 150,000,000 shares authorized at
September 30, 2017 and December 31, 2016; 59,998,748 and 52,328,492 shares
issued and outstanding at September 30, 2017 and December 31, 2016,
respectively		60		52
Additional paid-in capital		398,959		389,266
Accumulated deficit		(393,098)		(385,556)
Total stockholders’ equity		5,921		3,762
Total liabilities and stockholders’ equity	$	9,678	$	8,019

See accompanying notes to the unaudited condensed consolidated financial statements.

Vermillion, Inc.

Condensed Consolidated Statements of Operations

(Amounts in Thousands, Except Share and Per Share Amounts)

(Unaudited)


	Three Months Ended September 30,				Nine Months Ended September 30,
	2017		2016		2017		2016
Revenue:
Product	$	657	$	581	$	2,195	$	1,640
Service		42		42		128		197
Total revenue		699		623		2,323		1,837
Cost of revenue:(1)
Product		495		461		1,345		1,516
Service		284		356		855		416
Total cost of revenue		779		817		2,200		1,932
Gross profit (loss)		(80)		(194)		123		(95)
Operating expenses:
Research and development(2)		192		370		685		1,868
Sales and marketing(3)		1,050		1,606		3,114		5,514
General and administrative(4)		1,177		1,295		3,825		4,645
Total operating expenses		2,419		3,271		7,624		12,027
Loss from operations		(2,499)		(3,465)		(7,501)		(12,122)
Interest income (expense), net		(10)		(11)		(32)		(16)
Other income (expense), net		-		-		(9)		16
Net loss	$	(2,509)	$	(3,476)	$	(7,542)	$	(12,122)
Deemed dividend on warrant repricing		(942)		-		(942)		-
Net loss attributable to common stockholders	$	(3,451)	$	(3,476)	$	(8,484)	$	(12,122)
Net loss per share attributable to common stockholders - basic and diluted	$	(0.06)	$	(0.07)	$	(0.15)	$	(0.23)
Weighted average common shares used to compute basic and diluted net loss per common share		57,455,786		52,237,287		55,909,788		52,167,543
Non-cash stock-based compensation expense included in cost of revenue and operating expenses:
(1) Cost of revenue	$	29	$	27	$	108	$	73
(2) Research and development		2		10		7		63
(3) Sales and marketing		38		14		115		70
(4) General and administrative		257		210		767		655

See accompanying notes to the unaudited condensed consolidated financial statements.

Vermillion, Inc.

Condensed Consolidated Statements of Cash Flows

(Amounts in Thousands)

(Unaudited)


	Nine Months Ended
	September 30,
	2017		2016
Cash flows from operating activities:
Net loss	$	(7,542)	$	(12,122)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		599		523
Stock-based compensation expense		997		861
Loss on sale and disposal of property and equipment		4		3
Changes in operating assets and liabilities:
Accounts receivable		54		(44)
Prepaid expenses and other assets		312		354
Inventories		(62)		(5)
Accounts payable, accrued liabilities and other liabilities		(401)		(769)
Deferred revenue		62		-
Net cash used in operating activities		(5,977)		(11,199)
Cash flows from investing activities:
Purchase of property and equipment		(56)		(1,240)
Net cash used in investing activities		(56)		(1,240)
Cash flows from financing activities:
Proceeds from private placement offering of common stock, net of issuance costs		5,127		-
Proceeds from exercise of common stock warrants, net of issuance costs		3,577		-
Proceeds from issuance of DECD loan, net of issuance costs		-		1,967
Principal repayment of DECD loan		(136)		(73)
Repayment of capital lease obligations		(25)		(22)
Proceeds from issuance of common stock from exercise of stock options		-		5
Net cash provided by financing activities		8,543		1,877
Net increase (decrease) in cash and cash equivalents		2,510		(10,562)
Cash and cash equivalents, beginning of period		5,242		18,642
Cash and cash equivalents, end of period	$	7,752	$	8,080
Supplemental disclosure of cash flow information:
Cash paid during the period for interest		36		24
Supplemental disclosure of non-cash investing and financing activities:
Deemed dividend on warrant repricing		942		-

See accompanying notes to the unaudited condensed consolidated financial statements.

Vermillion, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

1. ORGANIZATION, BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING AND REPORTING POLICIES

Organization

Vermillion, Inc. (“Vermillion”; Vermillion and its wholly-owned subsidiaries are collectively referred to as the “Company,” “we” or “our”) is incorporated in the state of Delaware, and is engaged in the business of developing and commercializing diagnostic tests for gynecologic disease. The Company sells OVA1™ and Overa™ risk of malignancy tests for ovarian cancer (“OVA1” and “Overa,” respectively) through Vermillion’s wholly-owned Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) certified clinical laboratory, ASPiRA LABS, Inc. (“ASPiRA LABS”).

The Company also offers in-vitro diagnostic (“IVD”) trial services to third-party customers through its wholly-owned subsidiary, ASPiRA IVD, Inc. (“ASPiRA IVD”), which commenced operations in June 2016. ASPiRA IVD is a specialized, CLIA certified, laboratory provider dedicated to meeting the unique testing needs of IVD manufacturers seeking to commercialize high-complexity assays.

Going Concern

The Company has incurred significant net losses and negative cash flows from operations since inception, and as a result has an accumulated deficit of approximately $393,098,000 at September 30, 2017. The Company also expects to incur a net loss and negative cash flows from operations for the remainder of 2017 and the foreseeable future. The Company’s management believes that successful achievement of the Company’s business objectives will require additional financing. Given these conditions, there is substantial doubt about the Company’s ability to continue as a going concern. The condensed consolidated financial statements have been prepared on a going concern basis and do not include any adjustments that might result from these uncertainties.

The Company expects to raise capital through a variety of sources, which may include the exercise of common stock warrants, equity offerings, debt financing, collaborations, licensing arrangements, grants and government funding and strategic alliances. However, additional funding may not be available when needed or on terms acceptable to the Company. If the Company is unable to obtain additional capital, it may not be able to continue sales and marketing, research and development, or other operations on the scope or scale of current activity and that could have a material adverse effect on the Company’s business, results of operations and financial condition.

As discussed in Note 4, on August 31, 2017, certain investors exercised outstanding warrants for common stock for net proceeds of approximately $3,577,000 after deducting offering expenses.

As discussed in Note 4, on February 17, 2017, the Company completed a private placement pursuant to which certain investors purchased Vermillion common stock and warrants to purchase shares of Vermillion common stock for net proceeds of approximately $5,127,000 after deducting offering expenses.

As discussed in Note 3, in March 2016, the Company entered into an agreement (the “Loan Agreement”) pursuant to which it may borrow up to $4,000,000 from the State of Connecticut Department of Economic and Community Development (the “DECD”). An initial disbursement of $2,000,000 was made to the Company in April 2016 under the Loan Agreement. The Loan Agreement provides that the remaining $2,000,000 will be disbursed if and when the Company achieves certain future milestones.

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8-03 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management of the Company, all adjustments, consisting of normal recurring adjustments necessary for the fair statement of results for the periods presented, have been included. The results of operations of any interim period are not necessarily indicative of the results of operations for the full year or any other interim period.

The unaudited condensed consolidated financial statements and related disclosures have been prepared with the presumption that users of the interim unaudited condensed consolidated financial statements have read or have access to the audited consolidated financial statements for the preceding fiscal year. The condensed consolidated balance sheet at December 31, 2016 included in this report has been derived from the audited consolidated financial statements at that date but does not include all the information and footnotes required by GAAP. Accordingly, these unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2016 included in Vermillion’s Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on March 31, 2017 (the “2016 Annual Report”).

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimated results.

Significant Accounting and Reporting Policies

Revenue Recognition

Product Revenue

The Company has adopted ASC 954-605, Health Care Entities—Revenue Recognition, as revenue from laboratory services has become significant to the Company. The Company's product revenue is generated by performing diagnostic services using its OVA1 and Overa tests, and the service is completed upon the delivery of test results to the prescribing physician. The Company recognizes revenue related to billings for Medicare and commercial payers on an accrual basis, net of contractual and other adjustments, when amounts that will ultimately be realized can be estimated. Until a contract has been negotiated with a commercial payer or governmental program, the OVA1 and Overa tests may or may not be covered by these entities' existing reimbursement policies. In addition, patients do not enter into direct agreements with the Company that commit them to pay any portion of the cost of the tests in the event that their insurance declines to reimburse the Company. In the absence of an agreement with the patient or other clearly enforceable legal right to demand payment from the patient, the related revenue is only recognized upon cash receipt.

Estimates of amounts that the Company will ultimately realize require significant judgment by management. Some patients have out-of-pocket costs for amounts not covered by their insurance carrier, and the Company may bill the patient directly for these amounts in the form of co-payments and co-insurance in accordance with the patient’s health plan. Some payers may not cover the OVA1 and Overa tests as ordered by the prescribing physician under their reimbursement policies. The Company pursues reimbursement from such patients on a case-by-case basis. In the absence of contracted reimbursement coverage or the ability to estimate the amount that will ultimately be realized for the Company's services, revenue is recognized when cash is received.

See discussion of ASU No. 2014-09 (defined below) included in Recent Accounting Pronouncements below.

Service Revenue

The Company’s service revenue is generated by performing IVD trial services for third-party customers. In accordance with SAB Topic 13, service revenue is recognized when the following revenue recognition criteria are met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the fee is fixed or determinable; and (4) collectability is reasonably assured.

See discussion of ASU No. 2014-09 included in Recent Accounting Pronouncements below.

The Company has made no other significant changes in its critical accounting policies and estimates from those disclosed in the 2016 Annual Report.

Recent Accounting Pronouncements

In March 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting (Topic 718), Compensation - Stock Compensation (“ASU 2016-09”). The new guidance simplifies several aspects of the accounting for share-based payments, including immediate recognition of all excess tax benefits and deficiencies in the income statement, changing the threshold to qualify for equity classification up to the employees' maximum statutory tax rates, allowing an entity-wide accounting policy election to either estimate the number of awards that are expected to vest or account for forfeitures as they occur, and clarifying the classification on the statement of cash flows for the excess tax benefit and employee taxes paid when an employer withholds shares for tax-withholding purposes. ASU 2016-09 is effective for annual reporting periods beginning after December 15, 2016 and interim periods within that reporting period. The adoption of this standard is not expected to have a material effect on our financial statements.

In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”), which removes inconsistencies and weaknesses in revenue requirements, provides a more robust framework for addressing revenue issues, improves comparability of revenue recognition practices across entities, industries, jurisdictions and capital markets, provides more useful information to users of financial statements through improved disclosure requirements and simplifies the preparation of financial statements by reducing the number of requirements to which an entity must refer. This guidance requires that an entity depict the consideration by applying a five-step analysis in determining when and how revenue is recognized. The new model will require revenue recognition to depict the transfer of promised goods or services to customers in an amount that reflects the consideration a company expects to receive in exchange for those goods or services. On April 1, 2015, the FASB voted for a one-year deferral of the effective date of the new revenue recognition standard, ASU No. 2014-09. On July 15, 2015, the FASB affirmed these changes, which requires public entities to apply the amendments in ASU 2014-09 for annual reporting beginning after December 15, 2017. Early adoption is permitted beginning after December 31, 2016, the original effective date in ASU 2014-09.

The Company is in the early stages of its analysis of the effect ASU 2014-09 will have on its Service Revenue, but expects to complete its analysis during the fourth quarter of 2017.

The Company is also continuing its analysis of the effect ASU 2014-09 will have on its Product Revenue and also expects to complete this analysis in the fourth quarter of 2017. Revenue that is recognized upon the ultimate receipt of cash under the Company’s existing revenue recognition policy will have to be reassessed under the new standard. The Company’s implementation process is to review its patient account population to determine the appropriate distribution of patient accounts by payer (i.e., Medicare, patient pay, other third-party payer, etc.) into portfolios with similar collection experience that, when evaluated for collectability, will result in a materially

consistent revenue amount for such portfolios as if each patient account were evaluated on a contract-by-contract basis.

The Company has not yet determined if it plans to utilize the full retrospective or modified retrospective method of adoption, but anticipates adopting the new standard in the first quarter of 2018.

2. AGREEMENTS WITH QUEST DIAGNOSTICS INCORPORATED

In March 2015, the Company entered into a commercial agreement with Quest Diagnostics, Incorporated (“Quest Diagnostics”). Pursuant to this agreement, all OVA1 U.S. testing services for Quest Diagnostics customers were transferred to Vermillion’s wholly-owned subsidiary, ASPiRA LABS, as of August 2015. Pursuant to this agreement, as amended as of March 11, 2017, Quest Diagnostics has agreed to provide blood draw and logistics support by transporting specimens from its clients to ASPiRA LABS for testing through at least March 11, 2018 in exchange for a market value fee. Per the terms of this agreement, the Company will not offer to existing or future Quest Diagnostics customers tests that Quest Diagnostics offers.

3. COMMITMENTS AND CONTINGENCIES

Development Loan

On March 22, 2016, the Company entered into the Loan Agreement, pursuant to which the Company may borrow up to $4,000,000 from the DECD. Proceeds from the $2,000,000 April 2016 initial disbursement under the Loan Agreement were utilized primarily to fund the build-out, information technology infrastructure and other costs related to the Company’s Trumbull, Connecticut facility and operations. The loan bears interest at a fixed rate of 2.0% per annum and requires equal monthly payments of principal and interest until maturity, which occurs on April 15, 2026. As security for the loan, the Company has granted the DECD a blanket security interest in the Company’s personal and intellectual property. The DECD’s security interest in the Company’s intellectual property may be subordinated to a qualified institutional lender. Under the terms of the Loan Agreement, the Company may be eligible for forgiveness of up to $2,000,000 of the principal amount of the loan if the Company achieves certain job creation and retention milestones by March 1, 2018. Conversely, if the Company is unable to meet these job creation milestones, namely, hiring 40 full-time employees with a specified average annual salary within the allotted timeframe and retaining those employees for a two-year period or does not maintain the Company’s Connecticut operations for a period of 10 years, the DECD may require early repayment of a portion or all of the loan plus a penalty of 5%.

As discussed above, an initial disbursement of $2,000,000 was made to the Company on April 15, 2016 under the Loan Agreement. The Loan Agreement provides that the remaining $2,000,000 will be disbursed if and when the Company achieves certain future milestones. The loan may be prepaid at any time without premium or penalty .

Operating Leases

The Company leases facilities to support its business of discovering, developing and commercializing diagnostic tests in the fields of gynecologic disease. The Company’s principal facility, including the CLIA laboratory used by ASPiRA LABS, is located in Austin, Texas, and the CLIA laboratory used by ASPiRA IVD is located in Trumbull, Connecticut. The Austin, Texas lease includes an aggregate annual base rent of $85,000 and annual estimated common area charges, taxes and insurance of $46,000 and expires on January 31, 2019.

In October 2015, the Company entered into a lease agreement for a facility in Trumbull, Connecticut. The lease required initial payments for the buildout of leasehold improvements to the office space, which were approximately $596,000. The term of the lease is five years beginning after the initial date of occupancy in January

2016 and a rent abatement period of five months. The lease includes an aggregate annual base rent of $32,000 and annual estimated common area charges, taxes and insurance of $95,000.

Building rent for the three months ended September 30, 2017 and 2016 totaled $66,000 and $71,000, respectively. Building rent for the nine months ended September 30, 2017 and 2016 totaled $189,000 and $175,000, respectively.

Capital Lease

In April 2015, the Company leased a laboratory instrument for a total initial payment of $125,000 and ongoing payments of approximately $3,500 per month for 36 months after delivery. The agreement also requires minimum annual purchases of reagents from the manufacturer of the equipment. The laboratory instrument was placed into service on July 1, 2015.

The accumulated amortization of assets under capital lease obligations was $174,000 and $97,000 as of September 30, 2017 and 2016, respectively. The net book value of assets under capital lease obligations was $58,000 and $135,000 as of September 30, 2017 and 2016, respectively.

Non-cancelable Royalty Obligations

The Company is a party to an amended research collaboration agreement with The Johns Hopkins University School of Medicine under which the Company licenses certain of its intellectual property. Under the terms of the amended research collaboration agreement, Vermillion is required to pay the greater of 4% royalties on net sales of diagnostic tests using the assigned patents or annual minimum royalties of $57,500. Royalty expense for the three months ended September 30, 2017 and 2016 totalled $30,000 and $24,000, respectively. Royalty expense for the nine months ended September 30, 2017 and 2016 totalled $94,000 and $66,000, respectively.

4. STOCKHOLDERS’ EQUITY

2017 Warrant Repricing and Exercise

In December 2014, the Company issued warrants to purchase up to an aggregate of 4,166,659 shares of Vermillion common stock at an exercise price of $2.00 per share in conjunction with a December 2014 private placement of Vermillion common stock. The warrants expire by their original terms on December 23, 2017.

On August 31, 2017, certain holders exercised warrants to purchase 3,796,818 shares of Vermillion common stock in consideration for the Company agreeing to reduce the exercise price to $1.00 per share of Vermillion common stock.

The Company issued 3,796,818 shares of Vermillion common stock and received $3,796,818 in aggregate gross proceeds (approximately $3,577,000 net of transaction costs). The incremental non-cash fair value of approximately $942,000 from the modification of the warrants was calculated using the Black-Scholes model and recorded as a deemed dividend to the warrant holders within stockholders’ equity.

2017 Private Placement

On February 17, 2017, the Company completed a private placement pursuant to which certain investors purchased 3,747,125 shares of Vermillion common stock at a price of $1.40 per share. Vermillion also issued warrants to purchase shares of Vermillion common stock at a price of $0.125 per warrant share in the private placement. Net proceeds of the private placement were approximately $5,127,000 after deducting offering expenses. The warrants are exercisable for 2,810,338 shares of Vermillion common stock at $1.80 per share. The warrants expire on the fifth anniversary of the date of issuance or, if earlier, five business days after Vermillion delivers notice that the closing price per share of its common stock exceeded the exercise price for 20 consecutive trading days during the exercise period.

The sale of common stock and issuance of warrants qualified for equity treatment under GAAP. The respective values of the warrants and common stock were calculated using their relative fair values and classified under common stock and additional paid-in capital. The value ascribed to the warrants is $804,000 and to the common stock is approximately $4,296,000.

2010 Stock Incentive Plan

The Company’s employees, directors, and consultants are eligible to receive awards under the Vermillion, Inc. Second Amended and Restated 2010 Stock Incentive Plan (the “2010 Plan”). The 2010 Plan permits the granting of a variety of awards, including stock options, share appreciation rights, restricted shares, restricted share units, unrestricted shares, deferred share units, performance and cash-settled awards, and dividend equivalent rights. The 2010 Plan provides for issuance of up to 8,122,983 shares of Vermillion common stock, subject to adjustment as provided in the 2010 Plan.

Stock-Based Compensation

During the nine months ended September 30, 2017, the Company awarded to Vermillion’s non-employee directors 131,250 shares of restricted stock under the 2010 Plan having a fair value of approximately $281,000 as payment for services to be rendered in 2017. These shares of restricted stock vested 50% on June 1, 2017 and 25% on September 1, 2017, and the remaining 25% will vest on December 1, 2017. The Company also issued to certain consultants 27,878 shares of restricted stock under the 2010 Plan having a fair value of approximately $48,000.

During the three months ended September 30, 2017, the Company issued to certain consultants 5,037 shares of restricted stock under the 2010 Plan having a fair value of approximately $9,000. The Company did not make any awards of restricted stock to non-employee directors during the three months ended September 30, 2017.

During the nine months ended September 30, 2017, the Company also granted certain consultants options to purchase 70,000 shares of Vermillion common stock with an exercise price of $2.14 per share. The Company also granted certain officers and employees options to purchase approximately 916,000 shares of Vermillion common stock with an exercise price of $2.14 per share. In addition, the Company granted certain officers and employees options to purchase 14,500 shares of Vermillion common stock with an exercise price of $1.83 per share. These stock options generally vest 25% on each of the four anniversaries of the grant date.

During the nine months ended September 30, 2017, the Company also granted certain officers and employees options to purchase 250,000 shares of Vermillion common stock with an exercise price of approximately $2.14 per share with performance-based vesting based on certain metrics through December 31, 2017. These options vest 25% on each of the four anniversaries of the grant date if the performance-based metrics are met.

During the three months ended September 30, 2017, the Company granted certain officers and employees options to purchase 22,500 shares of Vermillion common stock with an exercise price of $1.32 per share. These stock options vest 25% on each of the four anniversaries of the vesting commencement date for each such stock option.

During the three months ended September 30, 2017, the Company granted certain consultants of the Company options to purchase 120,000 shares of Vermillion common stock with an exercise price of $1.32 per share. These stock options vest in 24 equal monthly installments beginning on the vesting commencement date for each such stock option.

The allocation of employee stock-based compensation expense by functional area for the three and nine months ended September 30, 2017 and 2016 was as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2017		2016		2017		2016
Cost of revenue	$	21	$	24	$	61	$	70
Research and development		—		10		5		63
Sales and marketing		38		10		108		66
General and administrative		216		198		630		623
Total	$	275	$	242	$	804	$	822

5. LOSS PER SHARE

The Company calculates basic loss per share using the weighted average number of shares of Vermillion common stock outstanding during the period. Because the Company is in a net loss position, diluted loss per share is calculated using the weighted average number of shares of Vermillion common stock outstanding and excludes the effects of 7,971,860 and 7,485,632 potential shares of Vermillion common stock as of September 30, 2017 and 2016, respectively, that are anti-dilutive. Potential shares of Vermillion common stock include incremental shares of Vermillion common stock issuable upon the exercise of outstanding warrants, stock options and unvested restricted stock units.

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995.

These statements involve a number of risks and uncertainties. Words such as “may,” “expects,” “intends,” “anticipates,” “believes,” “estimates,” “plans,” “seeks,” “could,” “should,” “continue,” “will,” “potential,” “projects” and similar expressions are intended to identify such forward-looking statements. Readers are cautioned that these forward-looking statements speak only as of the date on which this Quarterly Report on Form 10-Q is filed with the Securities and Exchange Commission (“SEC”), and, except as required by law, Vermillion, Inc. (“Vermillion” and, together with its subsidiaries, the “Company,” “we,” “our,” or “us”) does not assume any obligation to update, amend or clarify them to reflect events, new information or circumstances occurring after such date.

Examples of forward-looking statements regarding our business include the following:

projections or expectations regarding our future test volumes, revenue, cost of revenue, operating expenses, cash flow, results of operations and financial condition;

our plan to broaden our commercial focus from ovarian cancer to differential diagnosis of women with a range of gynecological disorders;

our planned business strategy and the anticipated timing of the implementation thereof;

plans with respect to our market expansion and growth, including plans to market Overa outside the United States;

plans to develop new algorithms and molecular diagnostic tests;

plans to develop a product or tool combining an OVA1 with results of a symptom index;

plans to establish our own payer coverage for OVA1 and Overa;

intentions to address clinical questions related to early disease detection, treatment response, monitoring of disease progression, prognosis and other issues in the fields of oncology and women’s health;

plans to leverage infrastructure and enhance our pipeline of future technologies by fostering relationships with in vitro diagnostic (“IVD”) companies;

plans with respect to ASPiRA IVD, Inc. (“ASPiRA IVD”);

expected service revenue growth based on ASPiRA IVD;

expected license revenue in future periods;

our planned focus on the execution of five core strategic business drivers in ovarian cancer diagnostics and specialized laboratory services to address unmet medical needs for women faced with gynecologic disease and other conditions and the continued development of our business;

anticipated efficacy of our products, product development activities and product innovations;

expected competition in the markets in which we compete;

plans with respect to ASPiRA LABS, Inc. (“ASPiRA LABS”);

expectations regarding future services provided by Quest Diagnostics Incorporated (“Quest Diagnostics”);

plans to expand our ovarian cancer franchise beyond OVA1, including with respect to Overa and OvaX;

plans regarding the commercialization of Overa;

plans to develop and perform laboratory developed tests (“LDTs”);

plans with respect to the Company’s pelvic mass registry, including anticipated sources of funding;

anticipated effects on reimbursement for OVA1 from changes to Novitas Solutions’ administrative requirements;

expectations regarding the Company’s monitoring and combining multiple protein biomarkers to create diagnostic tests to aid physicians considering treatment options for patients with complex diseases, and the Company’s future development of new In Vitro Diagnostic Multivariate Index Assays (IVDMIA);

expectations regarding existing and future collaborations and partnerships, including OVA1 and Overa distribution agreements;

plans regarding future publications;

our continued ability to comply with applicable governmental regulations, expectations regarding pending regulatory submissions and plans to seek regulatory approvals for our tests outside the United States;

our ability to obtain and maintain the regulatory approvals required to market Overa in other countries;

our continued ability to expand and protect our intellectual property portfolio;

anticipated liquidity and capital requirements;

anticipated future losses and our ability to continue as a going concern;

expectations regarding the second disbursement from our financing arrangement with the State of Connecticut Department of Economic and Community Development (the “DECD”);

expected expenditures, including the expected decrease in expenses related to research and development in 2017;

our ability to use our net operating loss carryforwards;

expected market adoption of our diagnostic tests, including OVA1 and Overa;

expectations regarding our ability to launch new products developed, licensed, co-marketed or acquired;

expectations regarding raising capital and the amount of financing anticipated to be required to fund our planned operations; and

expectations regarding reimbursement for our products, and our ability to obtain such reimbursement, from third-party payers such as private insurance companies and government insurance plans.

Forward-looking statements are subject to significant risks and uncertainties, including those discussed in Part I, Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2016 (our “2016 Annual Report”) and Part II, Item 1A. “Risk Factors” of our Quarterly Report on Form 10-Q for the three months ended March 31, 2017 (our “2017 First Quarterly Report”), that could cause actual results to differ materially from those projected in such forward-looking statements due to various factors, including our ability to increase the volume of OVA1 or Overa sales; our ability to market our test through sales channels other than Quest Diagnostics including ASPiRA LABS; failures by third-party payers to reimburse OVA1 or Overa or changes or variances in reimbursement rates; our ability to secure additional capital on acceptable terms to execute our business plan; our ability to commercialize OVA1 and/or Overa both within and outside the United States; in the event that we succeed in commercializing OVA1 and/or Overa outside the United States, the political, economic and other conditions affecting other countries (including foreign exchange rates); our ability to develop and commercialize additional diagnostic products and achieve market acceptance with respect to these products; our ability to compete successfully; our ability to obtain any regulatory approval required for our future diagnostic products; our or our

suppliers’ ability to comply with United States Food and Drug Administration (“FDA”) requirements for production, marketing and post-market monitoring of our products; additional costs that may be required to make further improvements to our manufacturing operations; our ability to maintain sufficient or acceptable supplies of immunoassay kits from our suppliers; our ability to continue to develop, protect and promote our proprietary technologies; future litigation against us, including infringement of intellectual property and product liability exposure; our ability to retain key employees; business interruptions; legislative actions resulting in higher compliance costs; changes in healthcare policy; our ability to comply with environmental laws; our ability to generate sufficient demand for ASPiRA LABS’ services to cover its operating costs; our ability to comply with the additional laws and regulations that apply to us in connection with the operation of ASPiRA LABS; our ability to comply with FDA regulations that relate to our products and to obtain any FDA clearance or approval required to develop and perform LDTs; ASPiRA IVD’s lack of operating history; ASPiRA IVD’s ability to generate and maintain business; fluctuations over time with respect to ASPiRA IVD’s operating results; ASPiRA IVD’s ability to enter into profitable contracts; ASPiRA IVD’s ability to maintain effective information systems without significant interruption; ASPiRA IVD’s ability to perform its services in compliance with contractual requirements, regulatory standards and ethical considerations; and our ability to continue as a going concern.

Overview

Our vision is to drive the advancement of women’s health by providing innovative methods to detect, monitor and manage the treatment of both benign and malignant gynecologic disease, with our primary focus being diseases of the female pelvic cavity.

We have expanded our corporate strategy with the goal of transforming Vermillion from a technology license company to a diagnostic service and bio-analytic solutions provider. Our plan is to broaden our commercial focus from ovarian cancer to differential diagnosis of women with a range of gynecological disorders. Our strategy is being deployed in three phases. The three phases are a rebuild phase, which was completed in the third quarter of 2015, a transformation phase, which is now virtually complete except for continuing expansion of payer coverage, and a market expansion and growth phase, which we began in 2017.

During the first phase, we expanded our leadership team by hiring several new senior leaders including a chief executive officer. In addition, we expanded our commercial strategy, reestablished medical and advisory support, rebuilt our patient advocacy strategy and established a billing system and a payer strategy outside of our relationship with Quest Diagnostics. During the second phase, we completed the process of obtaining licensure of ASPiRA LABS in all of the states that require licenses, and are in the process of establishing our own payer coverage for OVA1, Multivariate Index Assay (MIA), and our second-generation OVA1 test, trademarked Overa, Multivariate Index Assay, 2nd Generation (MIA2G). Overa has been launched on a targeted basis. In the third phase, we plan to fully commercialize OVA1 and Overa by utilizing the full national licensure of ASPiRA LABS, select laboratories for distribution, managed care coverage in select markets, our sales force and existing customer base. Unlike OVA1, Overa uses a global testing platform, which will allow Overa to be deployed internationally. We initiated the targeted launch of Overa in October 2016 with two key accounts converting from OVA1 to Overa. In October 2015, we announced registration of the CE mark for and clearance to market Overa in the European Union. We also plan to develop an LDT product series, which we refer to internally as OvaX. We anticipate that OvaX will include not only biomarkers, but also clinical risk factors, other diagnostics and patient history data in order to boost predictive value.

We are dedicated to the discovery, development and commercialization of novel high-value diagnostic and bio-analytical solutions that help physicians diagnose, treat and improve outcomes for women. Our tests are intended to detect, characterize and stage disease, and to help guide decisions regarding patient treatment, which may include decisions to refer patients to specialists, to perform additional testing, or to assist in monitoring response to therapy. A distinctive feature of our approach is to combine multiple biomarkers, other modalities and diagnostics, clinical risk factors and patient data into a single, reportable index score that has higher diagnostic accuracy than its constituents. We concentrate on our development of novel diagnostic tests for gynecologic disease, with an initial focus on ovarian cancer. We also intend to address clinical questions related to early disease detection, treatment response, monitoring of disease progression, prognosis and others through collaborations with leading academic and research institutions.

Our initial product, OVA1, is an FDA cleared blood test designed to, in addition to a physician’s clinical assessment of a woman with a pelvic mass, identify women who are at high risk of having a malignant ovarian

tumor prior to planned surgery. We have launched on a targeted basis a second-generation biomarker panel known as Overa, which is intended to maintain our product’s high sensitivity while improving specificity. We received FDA clearance for Overa in March 2016. Overa uses the Roche cobas 6000 platform.

In June 2014, Vermillion launched ASPiRA LABS, a Clinical Laboratory Improvements Amendments of 1988 (“CLIA”) certified national laboratory based in Austin, Texas, which specializes in applying biomarker-based technologies to address critical needs in the management of gynecologic cancers and disease. ASPiRA LABS provides expert diagnostic services using a state-of-the-art biomarker-based diagnostic algorithm to aid in clinical decision making and advance personalized treatment plans. The lab currently processes our OVA1 and Overa tests, and we plan to develop and perform LDTs at ASPiRA LABS in the future. ASPiRA LABS holds a CLIA Certificate of Registration and a state laboratory license in California, Florida, Maryland, New York, Pennsylvania and Rhode Island. The Centers for Medicare & Medicaid Services issued a provider number to ASPiRA LABS in March 2015.

In 2016, we created a new service within the ASPiRA channel strategy, “an ASPiRA IVD Services Program”. In April 2016, we formed ASPiRA IVD to offer IVD trial services to third-party customers. ASPiRA IVD is a specialized laboratory provider dedicated to meeting the unique testing needs of IVD manufacturers seeking to commercialize high-complexity assays. ASPiRA IVD was built around a core of laboratory expertise and an FDA-compliant quality system, and strives to deliver accurate and reliable results to its third-party customers suitable for FDA submission. ASPiRA IVD received a CLIA laboratory license in June 2016 and commenced operations in the second quarter of 2016.

In this program, we also plan to leverage our existing infrastructure and enhance our pipeline of future technologies by fostering relationships with IVD companies who are developing new diagnostics including companion diagnostics platforms. We believe this plan will allow us to continue to be innovative in evaluating potential diagnostics. Our goal with the addition of this line of business is to invest in our short-term and long-term enterprise value while leveraging our specimen bank, database, FDA experience, laboratory informatics and operating efficiency.

Strategy:

We are focused on the execution of five core strategic business drivers in ovarian cancer diagnostics and specialized laboratory services to build long-term value for our investors:

Maximizing the existing OVA1 opportunity in the United States by taking the lead in payer coverage and commercialization of OVA1. This strategy included the launch of a CLIA certified clinical laboratory, ASPiRA LABS, in June 2014;

Expanding the distribution platform beyond the U.S. by launching Overa, a next generation biomarker panel, while building the clinical utility and health economics foundation of both OVA1 and Overa, which we believe may allow for better domestic market penetration and international expansion (FDA clearance for Overa was received in March 2016);

Leveraging our existing database and specimen bank while building the largest specimen and data repository of gynecologic pelvic mass patients worldwide;

Expanding our product offerings to additional pelvic disease conditions such as endometriosis and polycystic ovarian syndrome by adding additional gynecologic bio-analytic solutions involving biomarkers, other modalities (e.g., imaging), clinical risk factors and patient data to aid diagnosis and risk stratification of women presenting with a pelvic mass disease; and

Expanding our customer offerings with the launch of our ASPiRA IVD laboratory services.

We believe that these business drivers will contribute significantly to addressing unmet medical needs for women faced with gynecologic disease and other conditions and the continued development of our business.

OVA1 addresses a clear clinical need, namely the pre-surgical identification of women who are at risk of having a malignant ovarian tumor. Numerous studies have documented the benefit of referral of these women to gynecologic oncologists for their initial surgery. Prior to the clearance of OVA1, no blood test had been cleared by

the FDA for physicians to use in the pre-surgical management of ovarian adnexal masses. OVA1 is a qualitative serum test that utilizes five well-established biomarkers and proprietary software cleared as part of the OVA1 510(k) to determine the likelihood of malignancy in women over age 18, with a pelvic mass for whom surgery is planned. OVA1 should not be used without an independent clinical/radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of OVA1 carries the risk of unnecessary testing, surgery and delayed diagnosis. OVA1 was developed through large pre-clinical studies in collaboration with numerous academic medical centers encompassing over 2,500 clinical samples. OVA1 was fully validated in a prospective multi-center clinical trial encompassing 27 sites reflective of the diverse nature of the clinical centers at which ovarian adnexal masses are evaluated.

Novitas Solutions, the Medicare contractor, covers and reimburses for OVA1. This local coverage determination from Novitas Solutions essentially provides national coverage for patients enrolled in Medicare as well as Medicare Advantage health plans. However, ASPiRA LABS initially experienced difficulty in obtaining payment from Novitas Solutions for most claims submitted due to Novitas Solutions’ administrative requirements. In October 2016, Novitas Solutions updated its administrative requirements for OVA1 reimbursement which has improved our ability to obtain reimbursement for OVA1 from Novitas Solutions.

In October 2016, we launched our pelvic mass specimen and data repository and began the collection of Institutional Review Board patient consents for collection and cataloguing of serum samples for future research purposes.

In November 2016, The American College of Obstetricians and Gynecologists ("ACOG”) issued Practice Bulletin Number 174 which included OVA1 as a “Multivariate Index Assay”. This bulletin outlines ACOG's “new” clinical management guidelines for adnexal mass management.

These new clinical management guidelines replace the July 2007 version, Practice Bulletin 83. Practice Bulletins summarize current information on techniques and clinical management issues for the practice of obstetrics and gynecology. Practice Bulletins are evidence-based documents, and recommendations are based on the evidence. This is also the only clinical management tool used for adnexal masses. Guidelines do not exist for adnexal masses, only Practice Bulletins. Guidelines do exist, however, for ovarian cancer management.

The Practice Bulletin recommends that obstetricians and gynecologists evaluating women with adnexal masses who do not meet Level A criteria of a low risk transvaginal ultrasound should proceed with Level B clinical guidelines. Level B guidelines state that the physician may use risk assessment tools such as existing CA125 technology or OVA1 (“Multivariate Index Assay”) as listed in the bulletin. Based on this, OVA1 has now achieved parity with CA125 as a Level B recommendation for the management of adnexal masses.

In December 2016, we received an FDA Clarification Letter regarding OVA1 and Overa. This letter was in reference to the September 7, 2016 FDA Safety Communication advising women and their physicians against the use of ovarian cancer screening tests for asymptomatic women.

In order to avoid any confusion, as well as to document the FDA position on OVA1 and Overa, Jeffrey Shuren, M.D., J.D., Director for the Center for Devices and Radiological Health at the FDA, sent a letter to Vermillion, dated December 21, 2016. In the letter, Dr. Shuren stated:

We agree that this safety communication does not apply to Vermillion’s FDA-cleared tests, OVA1 (MIA) and Overa (MIA2G), which are not screening tests for ovarian cancer.

FDA cleared OVA1 (MIA) and Overa (MIA2G) as aids to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The intended uses of the two assays are the same—to help physicians more reliably identify which patients would benefit from consultation with or referral to a gynecologic oncologist. OVA1 (MIA) and Overa (MIA2G) are indicated for women who present with an adnexal mass.

In March 2015, we entered into a new commercial agreement with Quest Diagnostics. Pursuant to this agreement, all OVA1 U.S. testing services for Quest Diagnostics customers were transferred to Vermillion’s wholly-owned subsidiary, ASPiRA LABS, as of August 10, 2015. Pursuant to this agreement, as amended as of March 11, 2017, Quest Diagnostics has agreed to provide blood draw and logistics support by transporting specimens from its clients to ASPiRA LABS for testing through at least March 11, 2018 in exchange for a market value fee. Per the

terms of this agreement, we will not offer to existing or future Quest Diagnostics customers CA 125-II or other tests that Quest Diagnostics offers.

In 2016, we continued to make progress with increased payer positive medical polices and in network agreements for a total of over 80 million covered lives.

In the first half of 2017, ASPiRA IVD services landed two top pharmaceutical trial service agreements including one enrollment study.

In July 2017 ASPiRA LABS expanded its patient advocacy program nationally to assist patients with proactive benefit checks, with over 90% resulting in OVA1 utilization.

In September 2017, the preliminary Protecting Access to Medicare Act of 2014 (PAMA) price for OVA1 and Overa was published by the Center for Medicare and Medicaid Service (CMS). The preliminary OVA1 rate is based on the median of private payer payments submitted by Vermillion as part of the market-based payment reforms mandated through PAMA. The Overa price was benchmarked to the only proteomic test currently on the fee schedule, which uses biomarkers and an algorithm to produce a prognostic score. The new rates, once finalized, are scheduled to become effective January 1, 2018.

In 2017, we continued to make progress with increased payer positive medical polices and in network agreements for a total of over 123 million covered lives, expected effective by February 2018.

Critical Accounting Policies and Estimates

There have been no material changes to our critical accounting policies and estimates from those disclosed in Item 7 of our 2016 Annual Report.

Results of Operations - Three Months Ended September 30, 2017 Compared to Three Months Ended September 30, 2016

The selected summary financial and operating data of the Company for the three months ended September 30, 2017 and 2016 were as follows:


	Three Months Ended September 30,				Increase (Decrease)
(dollars in thousands)	2017		2016		Amount		%
Revenue:
Product	$	657	$	581	$	76	13
Service		42		42		-	-
Total revenue		699		623		76	12
Cost of revenue:
Product		495		461		34	7
Service		284		356		(72)	(20)
Total cost of revenue		779		817		(38)	(5)
Gross profit		(80)		(194)		114	(59)
Operating expenses:
Research and development		192		370		(178)	(48)
Sales and marketing		1,050		1,606		(556)	(35)
General and administrative		1,177		1,295		(118)	(9)
Total operating expenses		2,419		3,271		(852)	(26)
Loss from operations		(2,499)		(3,465)		966	(28)
Interest income (expense), net		(10)		(11)		1	(9)
Other income (expense), net		-		-		-	-
Net loss		(2,509)		(3,476)		967	(28)

Product Revenue. Product revenue was $657,000 for the three months ended September 30, 2017 compared to $581,000 for the same period in 2016. Revenue for ASPiRA LABS is being recognized when the OVA1 test is being performed or when amounts that will ultimately be realized can be estimated. All other ASPiRA LABS revenue is being recognized on a cash basis and thus recognition of revenue lags the performance of some OVA1 tests. The 13% product revenue growth is due to improvement in the average unit price received per test compared to the same quarter in the prior year. The increase in average unit price was driven by an increase in client bill contracts, expansion of positive medical policy and contracting with payers, and improved billing and collection practices.

The number of OVA1 tests performed decreased 13% to approximately 1,954 OVA1 tests during the three months ended September 30, 2017 compared to approximately 2,257 OVA1 tests for the same period in 2016. The volume decrease was primarily due to the previously announced loss of a client bill customer in July 2017, which was concentrated in uncovered territories (territories not covered by an ASPiRA sales representative) and, to a lesser extent, the impact of hurricanes in two key areas (Texas and Florida). Partially affecting the volume decrease was modest year-over-year growth in covered territories (territories covered by an ASPiRA sales representative). We expect the test volume to improve in the fourth quarter relative to volume in the third quarter of 2017.

Service Revenue. Service revenue was $42,000 for the three months ended September 30, 2017 compared to $42,000 for the same period in 2016. Service revenue will vary from quarter to quarter based on the size of ongoing customer projects. Revenue for ASPiRA IVD is being recognized once certain revenue recognition criteria has been met (see Note 1 to the financial statements included in Part I, Item I of this Form 10-Q). We expect service revenue to increase in the fourth quarter of 2017 relative to service revenue in the third quarter of 2017 due to the performance of certain anticipated projects.

Cost of Revenue - Product. Cost of product revenue was $495,000 for the three months ended September 30, 2017 compared to $461,000 for the same period in 2016, representing an increase of 7% due primarily to some equipment maintenance costs and increased consultant fees incurred in the third quarter. We expect the cost of product revenue to decrease modestly in the fourth quarter of 2017 compared to the third quarter of 2017 as one-time costs incurred in the third quarter of 2017 are not expected to be repeated.

Cost of Revenue - Service. Cost of service revenue was $284,000 for the three months ended September 30, 2017 compared to $356,000 for the same period in 2016. The 20% decrease related primarily to consulting costs related to the opening of the lab in the third quarter of 2016, which were not repeated in 2017. We expect the cost of service revenue to increase in the fourth quarter of 2017 compared to the third quarter of 2017 due to expected variable costs relating to performance of certain projects.

Research and Development Expenses. Research and development expenses represent costs incurred to develop our technology and carry out clinical studies, and include personnel-related expenses, regulatory costs, reagents and supplies used in research and development laboratory work, infrastructure expenses, contract services and other outside costs. Research and development expenses for the three months ended September 30, 2017 decreased $178,000, or 48%, compared to the same period in 2016. This decrease was primarily due to a reduction in personnel and personnel related expenses. We expect research and development expenses to remain consistent with third quarter 2017 levels in the fourth quarter of 2017.

Sales and Marketing Expenses. Our sales and marketing expenses consist primarily of personnel-related expenses, education and promotional expenses, and infrastructure expenses. These expenses include the costs of educating physicians, laboratory personnel and other healthcare professionals regarding OVA1 and Overa. Sales and marketing expenses also include the costs of sponsoring continuing medical education, medical meeting participation, and dissemination of scientific and health economic publications. Sales and marketing expenses for the three months ended September 30, 2017 decreased $556,000, or 35%, compared to the same period in 2016. This decrease was primarily due to a reduction in consulting and, marketing services and lower health economic study costs in the third quarter of 2017 compared to 2016. We expect sales and marketing expenses to increase modestly over the remainder of 2017 as we focus efforts on the commercialization of OVA1 and Overa.

General and Administrative Expenses. General and administrative expenses consist primarily of personnel-related expenses, professional fees and other costs, including legal, finance and accounting expenses and other infrastructure expenses. General and administrative expenses for the three months ended September 30, 2017 decreased by $118,000, or 9%, compared to the same period in 2016. The decrease was primarily due to a reduction in consulting services. We expect general and administrative expenses to remain consistent with third quarter 2017 levels in the fourth quarter of 2017.

Results of Operations – Nine Months Ended September 30, 2017 Compared to Nine Months Ended September 30, 2016

The selected summary financial and operating data of the Company for the nine months ended September 30, 2017 and 2016 were as follows:


	Nine Months Ended September 30,				Increase (Decrease)
(dollars in thousands)	2017		2016		Amount		%
Revenue:
Product	$	2,195	$	1,640	$	555	34
Service		128		197		(69)	(35)
Total revenue		2,323		1,837		486	26
Cost of revenue:
Product		1,345		1,516		(171)	(11)
Service		855		416		439	106
Total cost of revenue		2,200		1,932		268	14
Gross profit		123		(95)		218	(229)
Operating expenses:
Research and development		685		1,868		(1,183)	(63)
Sales and marketing		3,114		5,514		(2,400)	(44)
General and administrative		3,825		4,645		(820)	(18)
Total operating expenses		7,624		12,027		(4,403)	(37)
Loss from operations		(7,501)		(12,122)		4,621	(38)
Interest income (expense), net		(32)		(16)		(16)	100
Other income (expense), net		(9)		16		(25)	(156)
Net loss		(7,542)		(12,122)		4,580	(38)

Product Revenue. Product revenue was $2,195,000 for the nine months ended September 30, 2017 compared to $1,640,000 for the same period in 2016. Revenue for ASPiRA LABS is being recognized when the OVA1 test is being performed or when amounts that will ultimately be realized can be estimated. All other ASPiRA LABS revenue is being recognized on a cash basis and thus recognition of revenue lags the performance of some OVA1 tests. The $555,000, or 34%, product revenue growth is due to improvement in the average unit price received per test compared to the same period in the prior year. The increase in average unit price was driven by an increase in client bill contracts, expansion of positive medical policy and contracting with payers, and improved billing and collection practices.

The number of OVA1 tests performed decreased 3% to approximately 6,665 OVA1 tests during the nine months ended September 30, 2017 compared to approximately 6,867 OVA1 tests for the same period in 2016. The volume decrease was primarily due to the previously announced loss of a client bill customer in July 2017, which was concentrated in uncovered territories (territories not covered by an ASPiRA sales representative) and, to a lesser extent, the impact of hurricanes in two key areas (Texas and Florida).

Service Revenue. Service revenue was $128,000 for the nine months ended September 30, 2017 compared to $197,000 for the same period in 2016, a decrease of $69,000, or 35%. Service revenue will vary from quarter to quarter based on the size of ongoing customer projects. Revenue for ASPiRA IVD is being recognized once certain revenue recognition criteria has been met (see Note 1 to the financial statements included in Part I, Item I of this Form 10-Q).

Cost of Revenue - Product. Cost of product revenue was $1,345,000 for the nine months ended September 30, 2017 compared to $1,516,000 for the same period in 2016, representing a decrease of $171,000, or 11%, due to operating efficiencies compared to the prior year.

Cost of Revenue - Service. Cost of service revenue was $855,000 for the nine months ended September 30, 2017 compared to $416,000 for the same period in 2016. ASPiRA IVD did not commence operations until June 2016 and thus included only four months of expense compared to three full quarters of expense in 2017.

Research and Development Expenses. Research and development expenses represent costs incurred to develop our technology and carry out clinical studies, and include personnel-related expenses, regulatory costs, reagents and supplies used in research and development laboratory work, infrastructure expenses, contract services and other outside costs. Research and development expenses through March 2016 also included costs related to activities performed under contracts with our collaborators and strategic partners. Research and development expenses for the nine months ended September 30, 2017 decreased $1,183,000, or 63%, compared to the same period in 2016. This decrease was primarily due to the expiration of our collaboration agreement with The Johns Hopkins University School of Medicine in March 2016 as well as lower personnel and personnel related expenses due to the clearance of Overa in March 2016.

Sales and Marketing Expenses. Our sales and marketing expenses consist primarily of personnel-related expenses, education and promotional expenses, and infrastructure expenses. These expenses include the costs of educating physicians, laboratory personnel and other healthcare professionals regarding OVA1 and Overa. Sales and marketing expenses also include the costs of sponsoring continuing medical education, medical meeting participation, and dissemination of scientific and health economic publications. Sales and marketing expenses for the nine months ended September 30, 2017 decreased $2,400,000, or 44%, compared to the same period in 2016. This decrease was primarily due to a reduction in personnel and personnel expenses and decreases in consulting and marketing services compared to the prior year period.

General and Administrative Expenses. General and administrative expenses consist primarily of personnel-related expenses, professional fees and other costs, including legal, finance and accounting expenses and other infrastructure expenses. General and administrative expenses for the nine months ended September 30, 2017 decreased by $820,000, or 18%, compared to the same period in 2016. The decrease was primarily due to the reduction of consulting services and ASPiRA IVD start-up expenses in 2016 not being repeated in 2017.

Liquidity and Capital Resources

We plan to continue to expend resources selling and marketing OVA1 and Overa, operating our IVD trial services business and developing additional diagnostic tests and service capabilities.

We have incurred significant net losses and negative cash flows from operations since inception. At September 30, 2017, we had an accumulated deficit of $393,098,000 and stockholders’ equity of $5,921,000. As of September 30, 2017, we had $7,752,000 of cash and cash equivalents and $2,229,000 of current liabilities. Working capital was $6,074,000 and $3,547,000 at September 30, 2017 and December 31, 2016, respectively.

The Company issued 3,796,818 shares of Vermillion common stock and received $3,796,818 in aggregate gross proceeds (approximately $3,577,000 net of transaction costs).

On February 17, 2017, the Company completed a private placement pursuant to which certain investors purchased Vermillion common stock and warrants to purchase shares of Vermillion common stock for net proceeds of approximately $5,127,000 after deducting offering expenses.

In March 2016, we entered into an agreement (the “Loan Agreement”) pursuant to which we may borrow up to $4,000,000 from the DECD. We received an initial disbursement of $2,000,000 in April 2016 under this

agreement. The remaining $2,000,000 will be disbursed if and when we achieve certain future milestones. Under the terms of the Loan Agreement, the Company may be eligible for forgiveness of up to $2,000,000 of the principal amount of the loan if the Company achieves certain job creation and retention milestones by March 1, 2018 (the “Measurement Date”). Conversely, if the Company is unable to meet these job creation milestones, namely, hiring 40 full-time employees with a specified average annual salary within the allotted timeframe and retaining those employees for a two-year period or does not maintain the Company’s Connecticut operations for a period of 10 years, the DECD may require early repayment of a portion or all of the loan plus a penalty of 5%. The Company is continuing to monitor progress towards achieving the employment milestone noted above. See also Note 3 to the financial statements included in Part I, Item I of this Form 10-Q for further information regarding the Loan Agreement.

We expect to incur a net loss and negative cash flows from operations in the remainder of 2017 and the foreseeable future. Our management believes that successful achievement of our business objectives will require additional financing. Given these conditions, there is substantial doubt about our ability to continue as a going concern. The condensed consolidated financial statements have been prepared on a going concern basis and do not include any adjustments that might result from these uncertainties.

Net cash used in operating activities was $5,977,000 for the nine months ended September 30, 2017, resulting primarily from the net loss reported of $7,542,000 and changes in accounts payable, accrued and other liabilities of $401,000, partially offset by stock compensation expense of $997,000, depreciation and amortization of $599,000 and changes in prepaid expenses of $312,000.

Net cash used in operating activities was $11,199,000 for the nine months ended September 30, 2016 resulting primarily from the net loss reported of $12,122,000 and changes in accounts payable, accrued and other liabilities of $769,000, partially offset by stock compensation expense of $861,000, depreciation and amortization of $523,000 and changes in prepaid expenses of $354,000.

Net cash used in investing activities was $56,000 and $1,240,000 for the nine months ended September 30, 2017 and 2016, respectively. The higher costs in 2016 resulted from purchases of property and equipment for the ASPiRA IVD laboratory.

Net cash provided by financing activities was $8,543,000 for the nine months ended September 30, 2017, which consisted primarily of proceeds from the sale of Vermillion common stock in our February 2017 private placement, net of issuance costs, as well proceeds from the exercise of common stock warrants, net of issuance costs.

Net cash provided by financing activities of $1,877,000 for the nine months ended September 30, 2016 consisted primarily of proceeds from the DECD loan.

Our future liquidity and capital requirements will depend upon many factors, including, among others:

resources devoted to sales, marketing and distribution capabilities;

the rate of OVA1 and Overa product adoption by physicians and patients;

the insurance payer community’s acceptance of and reimbursement for OVA1 and Overa;

the successful targeted launch of Overa;

resources devoted to our IVD trials laboratory and services;

the revenue generated by our IVD trial services business;

our plans to acquire or invest in other products, technologies and businesses; and

the market price of our common stock.

We have significant net operating loss (“NOL”) carryforwards as of September 30, 2017 for which a full valuation allowance has been provided due to our history of operating losses. Section 382 of the Internal Revenue Code of 1986, as amended, as well as similar state provisions may restrict our ability to use our NOL credit carryforwards due to ownership change limitations occurring in the past or that could occur in the future. These ownership changes may also limit the amount of NOL credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively.

Off-Balance Sheet Arrangements

As of September 30, 2017, we had no off-balance sheet arrangements that are reasonably likely to have a current or future material effect on our condensed consolidated financial condition, results of operations, liquidity, capital expenditures or capital resources.


ITEM 3.	QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Per Item 305(e) of Regulation S-K, the information called for by this Item 3 is not required.


ITEM 4.	CONTROLS AND PROCEDURES

Evaluation of disclosure controls and procedures.

Our senior management is responsible for establishing and maintaining a system of disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management, including its principal executive officer and principal financial officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Management, including our Chief Executive Officer and Chief Accounting Officer, performed an evaluation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of September 30, 2017. Based on this evaluation, our Chief Executive Officer and Chief Accounting Officer have concluded that as of September 30, 2017, our disclosure controls and procedures were effective.

Changes in internal controls over financial reporting.

There was no change in our internal control over financial reporting that occurred during the period covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II - OTHER INFORMATION


ITEM 1.	LEGAL PROCEEDINGS

In the ordinary course of business, we may periodically become subject to legal proceedings and claims arising in connection with ongoing business activities. The results of litigation and claims cannot be predicted with certainty, and unfavorable resolutions are possible and could materially and adversely affect our results of operations, cash flows and financial position. In addition, regardless of the outcome, litigation could have an adverse impact on us because of defense costs, diversion of management resources and other factors. While the outcome of these proceedings and claims cannot be predicted with certainty, there are no matters, as of September 30, 2017, that, in the opinion of management, will have a material adverse effect on our financial position, results of operations or cash flows.

ITEM 1A. RISK FACTORS

There have been no material changes to our risk factors from those disclosed under “Risk Factors” in Part I, Item 1A of our 2016 Annual Report and Part II, Item 1A of our 2017 First Quarterly Report. The risks and uncertainties described in our 2016 Annual Report and 2017 First Quarterly Report are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also materially adversely affect our business, financial condition or results of operations.

ITEM 6. EXHIBITS

(a) The following exhibits are filed or incorporated by reference with this report as indicated below:

Exhibit

Incorporated by Reference

Filed

Number

Exhibit Description

Form

File No.

Exhibit

Filing Date

Herewith

3.1

Fourth Amended and Restated Certificate of Incorporation of Vermillion, Inc. dated January 22, 2010

8-K

000-31617

3.1

January 25, 2010

3.2

Certificate of Amendment of Fourth Amended and Restated Certificate of Incorporation, effective June 19, 2014

10-Q

001-34810

3.2

August 14, 2014

3.3

Fifth Amended and Restated Bylaws of Vermillion, Inc., effective June 19, 2014

10-Q

001-34810

3.3

August 14, 2014

4.1

Form of Letter Agreement, by and between Vermillion, Inc. and certain warrant holders

8-K

001-34810

4.1

August 28, 2017

31.1

Certification of the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

√

31.2

Certification of the Chief Accounting Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

√

32.1

Certification of the Chief Executive Officer and Chief Accounting Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

(1)

101

Interactive Data Files

√


(1)	Furnished herewith

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.


	Vermillion, Inc.
Date: November 8, 2017	/s/ Valerie B. Palmieri
	Valerie B. Palmieri President and Chief Executive Officer (Principal Executive Officer)
Date: November 8, 2017	/s/ Eric J. Schoen
	Eric J. Schoen Senior Vice President, Finance and Chief Accounting Officer (Principal Financial Officer)

EX-31.1 2 vrml-20170930xex31_1.htm EX-31.1 Exhibit 311

Exhibit 31.1

Certification of the Chief Executive Officer Pursuant to Section 302 of

The Sarbanes-Oxley Act Of 2002

I, Valerie B. Palmieri, certify that:

I have reviewed this quarterly report on Form 10-Q of Vermillion, Inc.;

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 8, 2017

/s/ Valerie B. Palmieri

Valerie B. Palmieri

President and Chief Executive Officer

EX-31.2 3 vrml-20170930xex31_2.htm EX-31.2 Exhibit 312

Exhibit 31.2

Certification of the Chief Accounting Officer Pursuant to Section 302 of

The Sarbanes-Oxley Act Of 2002

I, Eric J. Schoen, certify that:

I have reviewed this quarterly report on Form 10-Q of Vermillion, Inc.;

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 8, 2017

/s/ Eric J. Schoen

Eric J. Schoen

Senior Vice President, Finance and Chief Accounting Officer

EX-32.1 4 vrml-20170930xex32_1.htm EX-32.1 Exhibit 321

Exhibit 32.1

Certification of the Chief Executive Officer and Senior Vice President, Finance and Chief Accounting Officer Pursuant to 18 U.S.C. Section 1350,

as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

with Respect to the Quarterly Report on Form 10-Q

for the Period Ended September 30, 2017

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, Chapter 63 of Title 18, United States Code), each of the undersigned officers of Vermillion, Inc., a Delaware corporation (the “Company”), does hereby certify, to the best of such officer’s knowledge, that:

The Company’s quarterly report on Form 10-Q for the period ended September 30, 2017, (the “Form 10-Q”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

Information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company.


Date: November 8, 2017	/s/ Valerie B. Palmieri
	Valerie B. Palmieri President and Chief Executive Officer (Principal Executive Officer)

Date: November 8, 2017	/s/ Eric J. Schoen
	Eric J. Schoen Senior Vice President, Finance and Chief Accounting Officer (Principal Financial Officer)

The certification set forth above is being furnished as an Exhibit solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and is not being filed as part of the Form 10-Q or as a separate disclosure document of the Company or the certifying officers.

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vrml:EmployeeStockBasedCompensationMember 2016-01-01 2016-09-30 0000926617 us-gaap:CostOfSalesMember vrml:EmployeeStockBasedCompensationMember 2016-01-01 2016-09-30 0000926617 vrml:EmployeeStockBasedCompensationMember 2016-01-01 2016-09-30 0000926617 us-gaap:SellingAndMarketingExpenseMember 2016-01-01 2016-09-30 0000926617 us-gaap:ResearchAndDevelopmentExpenseMember 2016-01-01 2016-09-30 0000926617 us-gaap:GeneralAndAdministrativeExpenseMember 2016-01-01 2016-09-30 0000926617 us-gaap:CostOfSalesMember 2016-01-01 2016-09-30 0000926617 us-gaap:AssetsHeldUnderCapitalLeasesMember 2017-09-30 0000926617 us-gaap:AssetsHeldUnderCapitalLeasesMember 2016-09-30 0000926617 2017-09-30 0000926617 2016-12-31 0000926617 2017-10-31 0000926617 2017-01-01 2017-09-30 vrml:item vrml:employee xbrli:pure iso4217:USD xbrli:shares iso4217:USD xbrli:shares false --12-31 Q3 2017 2017-09-30 10-Q 0000926617 59998748 Smaller Reporting Company VERMILLION, INC. 881000 514000 275000 221000 1464000 1430000 97000 174000 389266000 398959000 73000 655000 63000 70000 822000 70000 623000 63000 66000 27000 210000 10000 14000 242000 24000 198000 10000 10000 108000 767000 7000 115000 804000 61000 630000 5000 108000 29000 257000 2000 38000 275000 21000 216000 38000 7485632 7971860 8019000 9678000 6108000 8303000 <div> <div style="margin-left:0pt;margin-right:0pt;"> Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8-03 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management of the Company, all adjustments, consisting of normal recurring adjustments necessary for the fair statement of results for the periods presented, have been included. The results of operations of any interim period are not necessarily indicative of the results of operations for the full year or any other interim period. The unaudited condensed consolidated financial statements and related disclosures have been prepared with the presumption that users of the interim unaudited condensed consolidated financial statements have read or have access to the audited consolidated financial statements for the preceding fiscal year. The condensed consolidated balance sheet at December 31, 2016 included in this report has been derived from the audited consolidated financial statements at that date but does not include all the information and footnotes required by GAAP. Accordingly, these unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2016 included in Vermillion’s Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on March 31, 2017 (the “2016 Annual Report”). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimated results.  </div> </div> 3500 18642000 8080000 5242000 7752000 -10562000 2510000 2.00 1.80 1.00 2810338 <div> <div style="margin-left:0pt;margin-right:0pt;"> 3.   COMMITMENTS AND CONTINGENCIES Development Loan On March 22, 2016, the Company entered into the Loan Agreement, pursuant to which the Company may borrow up to $4,000,000 from the DECD. Proceeds from the <a name="_cp_text_1_48"></a>$2,000,000 April 2016 initial disbursement under the Loan Agreement were utilized primarily to fund the build-out, information technology infrastructure and other costs related to the Company’s Trumbull, Connecticut facility and operations. The loan bears interest at a fixed rate of 2.0% per annum and requires equal monthly payments of principal and interest until maturity, which occurs on April 15, 2026. As security for the loan, the Company has granted the DECD a blanket security interest in the Company’s personal and intellectual property. The DECD’s security interest in the Company’s intellectual property may be subordinated to a qualified institutional lender. Under the terms of the Loan Agreement, the Company may be eligible for forgiveness of up to $2,000,000 of the principal amount of the loan if the Company achieves certain job creation and retention milestones by March 1, 2018. Conversely, if the Company is unable to meet these job creation milestones, namely, hiring 40 full-time employees with a specified average annual salary within the allotted timeframe and retaining those employees for a two-year period or does not maintain the Company’s Connecticut operations for a period of 10 years, the DECD may require early repayment of a portion or all of the loan plus a penalty of 5%.      As discussed above, an initial disbursement of $2,000,000 was made to the Company on April 15, 2016 under the Loan Agreement. The Loan Agreement provides that the remaining $2,000,000 will be disbursed if and when the Company achieves certain future milestones. The loan may be prepaid at any time without premium or penalty<a name="T7"></a><a name="T8"></a><a name="T9"></a>. Operating Leases The Company leases facilities to support its business of discovering, developing and commercializing diagnostic tests in the fields of gynecologic disease. The Company’s principal facility, including the CLIA laboratory used by ASPiRA LABS, is located in Austin, Texas, and the CLIA laboratory used by ASPiRA IVD is located in Trumbull, Connecticut. The Austin, Texas lease includes an aggregate annual base rent of $85,000 and annual estimated common area charges, taxes and insurance of $46,000 and expires on January 31, 2019.     In October 2015, the Company entered into a lease agreement for a facility in Trumbull, Connecticut. The lease required initial payments for the buildout of leasehold improvements to the office space, which were approximately $596,000. The term of the lease is five years beginning after the initial date of occupancy in January 2016 and a rent abatement period of five months. The lease includes an aggregate annual base rent of $32,000 and annual estimated common area charges, taxes and insurance of $95,000.   Building rent for the three months ended September 30, 2017 and 2016 totaled $66,000 and $71,000, respectively. Building rent for the nine months ended September 30, 2017 and 2016 totaled $189,000 and $175,000, respectively. Capital Lease In April 2015, the Company leased a laboratory instrument for a total initial payment of $125,000 and ongoing payments of approximately $3,500 per month for 36 months after delivery. The agreement also requires minimum annual purchases of reagents from the manufacturer of the equipment. The laboratory instrument was placed into service on July 1, 2015. The accumulated amortization of assets under capital lease obligations was $174,000 and $97,000 as of September 30, 2017 and 2016, respectively. The net book value of assets under capital lease obligations was $58,000 and $135,000 as of September 30, 2017 and 2016, respectively.   Non-cancelable Royalty Obligations The Company is a party to an amended research collaboration agreement with The Johns Hopkins University School of Medicine under which the Company licenses certain of its intellectual property. Under the terms of the amended research collaboration agreement, Vermillion is required to pay the greater of 4% royalties on net sales of diagnostic tests using the assigned patents or annual minimum royalties of $57,500. Royalty expense for the three months ended September 30, 2017 and 2016 totalled $30,000 and $24,000, respectively. Royalty expense for the nine months ended September 30, 2017 and 2016 totalled $94,000 and $66,000, respectively.    </div> </div> 0.001 1.40 0.001 150000000 150000000 52328492 3747125 3796818 59998748 52328492 59998748 52000 4296000 60000 <div> <div style="margin-left:0pt;margin-right:0pt;"> 4.   STOCKHOLDERS’ EQUITY 2017 Warrant Repricing and Exercise       <a name="T3231985711"></a> In December 2014, the Company issued warrants to purchase up to an aggregate of 4,166,659 shares of Vermillion common stock at an exercise price of $2.00 per share in conjunction with a December 2014 private placement of Vermillion common stock.  The warrants expire by their original terms on December 23, 2017. On August 31, 2017, certain holders exercised warrants to purchase 3,796,818 shares of Vermillion common stock in consideration for the Company agreeing to reduce the exercise price to $1.00 per share of Vermillion common stock.  The Company issued 3,796,818 shares of Vermillion common stock and received $3,796,818 in aggregate gross proceeds (approximately $3,577,000 net of transaction costs). The incremental non-cash fair value of approximately $942,000 from the modification of the warrants was calculated using the Black-Scholes model and recorded as a deemed dividend to the warrant holders within stockholders’ equity. 2017 Private Placement        On February 17, 2017, the Company completed a private placement pursuant to which certain investors purchased 3,747,125 shares of Vermillion common stock at a price of $1.40 per share. Vermillion also issued warrants to purchase shares of Vermillion common stock at a price of $0.125 per warrant share in the private placement. Net proceeds of the private placement were approximately $5,127,000 after deducting offering expenses. The warrants are exercisable for 2,810,338 shares of Vermillion common stock at $1.80 per share. The warrants expire on the fifth anniversary of the date of issuance or, if earlier, five business days after Vermillion delivers notice that the closing price per share of its common stock exceeded the exercise price for 20 consecutive trading days during the exercise period. The sale of common stock and issuance of warrants qualified for equity treatment under GAAP. The respective values of the warrants and common stock were calculated using their relative fair values and classified under common stock and additional paid-in capital. The value ascribed to the warrants is $804,000 and to the common stock is approximately $4,296,000. 2010 Stock Incentive Plan The Company’s employees, directors, and consultants are eligible to receive awards under the Vermillion, Inc. <a name="_cp_text_4_18"></a>Second Amended and Restated 2010 Stock Incentive Plan (the “2010 Plan”). The 2010 Plan permits the granting of a variety of awards, including stock options, share appreciation rights, restricted shares, restricted share units, unrestricted shares, deferred share units, performance and cash-settled awards, and dividend equivalent rights. The 2010 Plan provides for issuance of up to 8,122,983 shares of Vermillion common stock, subject to adjustment as provided in the 2010 Plan. Stock-Based Compensation During the nine months ended September 30, 2017, the Company awarded to Vermillion’s non-employee directors 131,250 shares of restricted stock under the 2010 Plan having a fair value of approximately $281,000 as payment for services to be rendered in 2017. These shares of restricted stock vested 50% on June 1, 2017 and 25% on September 1, 2017, and the remaining 25% will vest on December 1, 2017. The Company also issued to certain consultants 27,878 shares of restricted stock under the 2010 Plan having a fair value of approximately $48,000. During the three months ended September 30, 2017, the Company issued to certain consultants 5,037 shares of restricted stock under the 2010 Plan having a fair value of approximately $9,000. The Company did not make any awards of restricted stock to non-employee directors during the three months ended September 30, 2017.  During the nine months ended September 30, 2017, the Company also granted certain consultants options to purchase 70,000 shares of Vermillion common stock with an exercise price of $2.14 per share.  The Company also granted certain officers and employees options to purchase approximately 916,000 shares of Vermillion common stock with an exercise price of $2.14 per share. In addition, the Company granted certain officers and employees options to purchase 14,500 shares of Vermillion common stock with an exercise price of $1.83 per share. These stock options generally vest 25% on each of the four anniversaries of the grant date.   During the nine months ended September 30, 2017, the Company also granted certain officers and employees options to purchase 250,000 shares of Vermillion common stock with an exercise price of approximately $2.14 per share with performance-based vesting based on certain metrics through December 31, 2017. These options vest 25% on each of the four anniversaries of the grant date if the performance-based metrics are met. During the three months ended September 30, 2017, the Company granted certain officers and employees options to purchase 22,500 shares of Vermillion common stock with an exercise price of $1.32 per share. These stock options vest 25% on each of the four anniversaries of the vesting commencement date for each such stock option.  During the three months ended September 30, 2017, the Company granted certain consultants of the Company options to purchase 120,000 shares of Vermillion common stock with an exercise price of $1.32 per share. These stock options vest in 24 equal monthly installments beginning on the vesting commencement date for each such stock option. The allocation of employee stock-based compensation expense by functional area for the three and nine months ended September 30, 2017 and 2016 was as follows:   <div style="width:100%"><table cellpadding="0" cellspacing="0" style="border-collapse:collapse;width: 100.00%;margin-left:0pt;"> <tr> <td valign="bottom" style="width:38.88%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;"> </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;">   </td> <td valign="bottom" style="width:12.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;">   </td> <td valign="bottom" style="width:11.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;">   </td> <td valign="bottom" style="width:12.70%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;">   </td> <td valign="bottom" style="width:11.04%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;">   </td> </tr> <tr> <td valign="bottom" style="width:38.88%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:24.75pt;padding:0pt;"> </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:24.75pt;padding:0pt;">   </td> <td colspan="5" valign="bottom" style="width:00.02%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:24.75pt;padding:0pt;"> Three Months Ended September 30, </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:24.75pt;padding:0pt;">   </td> <td colspan="5" valign="bottom" style="width:00.02%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:24.75pt;padding:0pt;"> Nine Months Ended September 30, </td> </tr> <tr> <td valign="top" style="width:38.88%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:12.75pt;padding:0pt;"> (in thousands) </td> <td valign="top" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:12.75pt;padding:0pt;">   </td> <td colspan="2" valign="bottom" style="width:00.02%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:12.75pt;padding:0pt;"> 2017 </td> <td valign="bottom" style="width:01.82%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:12.75pt;padding:0pt;">   </td> <td colspan="2" valign="bottom" style="width:00.02%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:12.75pt;padding:0pt;"> 2016 </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:12.75pt;padding:0pt;">   </td> <td colspan="2" valign="bottom" style="width:00.02%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:12.75pt;padding:0pt;"> 2017 </td> <td valign="bottom" style="width:01.82%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:12.75pt;padding:0pt;">   </td> <td colspan="2" valign="bottom" style="width:00.02%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:12.75pt;padding:0pt;"> 2016 </td> </tr> <tr> <td valign="bottom" style="width:38.88%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;"> Cost of revenue </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;"> $ </td> <td valign="bottom" style="width:12.86%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">21  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;"> $ </td> <td valign="bottom" style="width:11.80%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">24  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;"> $ </td> <td valign="bottom" style="width:12.70%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">61  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;"> $ </td> <td valign="bottom" style="width:11.04%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">70  </td> </tr> <tr> <td valign="bottom" style="width:38.88%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;"> Research and development </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:12.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">  — </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:11.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">10  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:12.70%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">5  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:11.04%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">63  </td> </tr> <tr> <td valign="bottom" style="width:38.88%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;"> Sales and marketing </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:12.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">38  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:11.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">10  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:12.70%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">108  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:11.04%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">66  </td> </tr> <tr> <td valign="bottom" style="width:38.88%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;"> General and administrative </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:12.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">216  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:11.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">198  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:12.70%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">630  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:11.04%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">623  </td> </tr> <tr> <td valign="bottom" style="width:38.88%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;"> Total </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;"> $ </td> <td valign="bottom" style="width:12.86%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">275  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;"> $ </td> <td valign="bottom" style="width:11.80%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">242  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;"> $ </td> <td valign="bottom" style="width:12.70%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">804  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;"> $ </td> <td valign="bottom" style="width:11.04%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">822  </td> </tr> <tr> <td valign="bottom" style="width:38.88%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;"> </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:2pt double #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:12.86%;border-top:2pt double #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:2pt double #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:11.80%;border-top:2pt double #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:2pt double #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:12.70%;border-top:2pt double #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:2pt double #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:11.04%;border-top:2pt double #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> </tr> </table></div> </div> </div> 1932000 817000 2200000 779000 1516000 461000 1345000 495000 416000 356000 855000 284000 <div> <div style="margin-left:0pt;margin-right:0pt;"> 2.   AGREEMENTS WITH QUEST DIAGNOSTICS INCORPORATED In March 2015, the Company entered into a commercial agreement with Quest Diagnostics, <a name="_cp_text_1_39"></a>Incorporated (“Quest Diagnostics”). Pursuant to this agreement,  <a name="_cp_text_1_40"></a>all OVA1 U.S. testing services for Quest Diagnostics <a name="_cp_text_1_42"></a>customers were transferred to Vermillion’s wholly-owned subsidiary, ASPiRA LABS, as of August 2015. Pursuant to this agreement, as amended as of March 11, 2017, Quest Diagnostics has agreed to provide blood draw and logistics support by transporting specimens from its clients to ASPiRA LABS for testing through at least March 11, 2018 in exchange for a market value fee. Per the terms of this agreement, the Company will not offer to existing or future Quest Diagnostics customers tests that Quest Diagnostics offers. </div> </div> 4000000 0.02 2026-04-15 P10Y 2000000 62000 523000 599000 -0.23 -0.07 -0.15 -0.06 <div> <div style="margin-left:0pt;margin-right:0pt;"> 5.   LOSS PER SHARE The Company calculates basic loss per share using the weighted average number of shares of Vermillion common stock outstanding during the period. Because the Company is in a net loss position, diluted loss per share is calculated using the weighted average number of shares of Vermillion common stock outstanding and excludes the effects of 7,971,860 and  7,485,632 potential shares of Vermillion common stock as of September 30, 2017 and 2016, respectively, that are anti-dilutive. Potential shares of Vermillion common stock include incremental shares of Vermillion common stock issuable upon the exercise of outstanding warrants, stock options and unvested restricted stock units. </div> </div> -3000 -4000 4645000 1295000 3825000 1177000 -95000 -194000 123000 -80000 -769000 -401000 44000 -54000 62000 5000 62000 -354000 -312000 -16000 -11000 -32000 -10000 24000 36000 93000 155000 2019-01-31 596000 P5Y 4257000 3757000 8019000 9678000 2561000 2229000 1667000 1528000 1877000 8543000 -1240000 -56000 -11199000 -5977000 -12122000 -3476000 -7542000 -2509000 -12122000 -3476000 -8484000 -3451000 <div> <div style="margin-left:0pt;margin-right:0pt;"> Recent Accounting Pronouncements In March 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting (Topic 718), Compensation - Stock Compensation (“ASU 2016-09”). The new guidance simplifies several aspects of the accounting for share-based payments, including immediate recognition of all excess tax benefits and deficiencies in the income statement, changing the threshold to qualify for equity classification up to the employees' maximum statutory tax rates, allowing an entity-wide accounting policy election to either estimate the number of awards that are expected to vest or account for forfeitures as they occur, and clarifying the classification on the statement of cash flows for the excess tax benefit and employee taxes paid when an employer withholds shares for tax-withholding purposes. ASU 2016-09 is effective for annual reporting periods beginning after December 15, 2016 and interim periods within that reporting period. The adoption of this standard is not expected to have a material effect on our financial statements. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”), which removes inconsistencies and weaknesses in revenue requirements, provides a more robust framework for addressing revenue issues, improves comparability of revenue recognition practices across entities, industries, jurisdictions and capital markets, provides more useful information to users of financial statements through improved disclosure requirements and simplifies the preparation of financial statements by reducing the number of requirements to which an entity must refer. This guidance requires that an entity depict the consideration by applying a five-step analysis in determining when and how revenue is recognized. The new model will require revenue recognition to depict the transfer of promised goods or services to customers in an amount that reflects the consideration a company expects to receive in exchange for those goods or services. On April 1, 2015, the FASB voted for a one-year deferral of the effective date of the new revenue recognition standard, ASU No. 2014-09. On July 15, 2015, the FASB affirmed these changes, which requires public entities to apply the amendments in ASU 2014-09 for annual reporting beginning after December 15, 2017. Early adoption is permitted beginning after December 31, 2016, the original effective date in ASU 2014-09. The Company is in the early stages of its analysis of the effect ASU 2014-09 will have on its Service Revenue, but expects to complete its analysis during the fourth quarter of 2017. The Company is also continuing its analysis of the effect ASU 2014-09 will have on its Product Revenue and also expects to complete this analysis in the fourth quarter of 2017. Revenue that is recognized upon the ultimate receipt of cash under the Company’s existing revenue recognition policy will have to be reassessed under the new standard. The Company’s implementation process is to review its patient account population to determine the appropriate distribution of patient accounts by payer  (i.e., Medicare, patient pay, other third-party payer, etc.) into portfolios with similar collection experience that, when evaluated for collectability, will result in a materially consistent revenue amount for such portfolios as if each patient account were evaluated on a contract-by-contract basis. The Company has not yet determined if it plans to utilize the full retrospective or modified retrospective method of adoption, but anticipates adopting the new standard in the first quarter of 2018. </div> </div> 16000 -9000 12027000 3271000 7624000 2419000 -12122000 -3465000 -7501000 -2499000 175000 71000 189000 66000 <div> <div style="margin-left:0pt;margin-right:0pt;"> 1.   ORGANIZATION, BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING AND REPORTING POLICIES Organization Vermillion, Inc. (“Vermillion”; Vermillion and its wholly-owned subsidiaries are collectively referred to as the “Company<a name="_cp_text_1_15"></a>,” “we” or “our”) is incorporated in the state of Delaware, and is engaged in the business of developing and commercializing diagnostic tests for gynecologic disease. The Company sells OVA1™ and Overa™ risk of malignancy tests for ovarian cancer (“OVA1” and “Overa,” respectively) through Vermillion’s wholly-owned Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) certified clinical laboratory, ASPiRA LABS, Inc. (“ASPiRA LABS”). The Company also offers in-vitro diagnostic (“IVD”) trial services to third-party customers through its wholly-owned subsidiary, ASPiRA IVD, Inc. (“ASPiRA IVD”), which commenced operations in June 2016. ASPiRA IVD is a specialized, CLIA certified, laboratory provider dedicated to meeting the unique testing needs of IVD manufacturers seeking to commercialize high-complexity assays. Going Concern The Company has incurred significant net losses and negative cash flows from operations since inception, and as a result has an accumulated deficit of approximately $393,098,000 at September 30, 2017. The Company also expects to incur a net loss and negative cash flows from operations for the remainder of 2017 and the foreseeable future. The Company’s management believes that successful achievement of the Company’s business objectives will require additional financing. Given these conditions, there is substantial doubt about the Company’s ability to continue as a going concern. The condensed consolidated financial statements have been prepared on a going concern basis and do not include any adjustments that might result from these uncertainties. The Company expects to raise capital through a variety of sources, which may include the exercise of common stock warrants, equity offerings, debt financing, collaborations, licensing arrangements, grants and government funding and strategic alliances. However, additional funding may not be available when needed or on terms acceptable to the Company. If the Company is unable to obtain additional capital, it may not be able to continue sales and marketing, research and development, or other operations on the scope or scale of current activity and that could have a material adverse effect on the Company’s business, results of operations and financial condition. As discussed in Note 4, on August 31, 2017, certain investors exercised outstanding warrants for common stock for net proceeds of approximately $3,577,000 after deducting offering expenses. As discussed in Note 4, on February 17, 2017, the Company completed a private placement pursuant to which certain investors purchased Vermillion common stock and warrants to purchase shares of Vermillion common stock for net proceeds of approximately $5,127,000 after deducting offering expenses. As discussed in Note 3, in March 2016, the Company entered into an agreement (the “Loan Agreement”) pursuant to which it may borrow up to $4,000,000 from the State of Connecticut Department of Economic and Community Development (the “DECD”). An initial disbursement of $2,000,000 was made to the Company in April 2016 under the Loan Agreement. The Loan Agreement provides that the remaining $2,000,000 will be disbursed if and when the Company achieves certain future milestones.  Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8-03 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management of the Company, all adjustments, consisting of normal recurring adjustments necessary for the fair statement of results for the periods presented, have been included. The results of operations of any interim period are not necessarily indicative of the results of operations for the full year or any other interim period. The unaudited condensed consolidated financial statements and related disclosures have been prepared with the presumption that users of the interim unaudited condensed consolidated financial statements have read or have access to the audited consolidated financial statements for the preceding fiscal year. The condensed consolidated balance sheet at December 31, 2016 included in this report has been derived from the audited consolidated financial statements at that date but does not include all the information and footnotes required by GAAP. Accordingly, these unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2016 included in Vermillion’s Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on March 31, 2017 (the “2016 Annual Report”). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimated results.  Significant Accounting and Reporting Policies <p style="margin:0pt 0pt 2.25pt 10pt;line-height:normal;text-indent: -10pt;text-align:justify;text-justify:inter-ideograph;border-top:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;font-family:Arial Unicode MS;font-size: 10pt"> Revenue Recognition <p style="margin:0pt 0pt 2.25pt 10pt;line-height:normal;text-indent: -10pt;text-align:justify;text-justify:inter-ideograph;border-top:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;font-family:Arial Unicode MS;font-size: 10pt"> <p style="margin:0pt 0pt 2.25pt 10pt;line-height:normal;text-indent: -10pt;text-align:justify;text-justify:inter-ideograph;border-top:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;font-family:Arial Unicode MS;font-size: 10pt"> Product Revenue <p style="margin:0pt 0pt 2.25pt 10pt;line-height:normal;text-indent: -10pt;text-align:justify;text-justify:inter-ideograph;border-top:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;font-family:Arial Unicode MS;font-size: 8pt">         <font style="display: inline;font-family:Times New Roman;color:#000000;font-size:10pt;background-color: #FFFFFF;;font-size: 10pt;font-family:Arial Unicode MS;text-indent:0pt;margin-left:0pt;padding:0pt 36pt 0pt 0pt;">The Company has adopted ASC 954-605, Health Care Entities—Revenue Recognition, as revenue from laboratory services has become significant to the Company. The Company's product revenue is generated by performing diagnostic services using its OVA1 and Overa tests, and the service is completed upon the delivery of test results to the prescribing physician. The Company recognizes revenue related to billings for Medicare and commercial payers on an accrual basis, net of contractual and other adjustments, when amounts that will ultimately be realized can be estimated. Until a contract has been negotiated with a commercial payer or governmental program, the OVA1 and Overa tests may or may not be covered by these entities' existing reimbursement policies. In addition, patients do not enter into direct agreements with the Company that commit them to pay any portion of the cost of the tests in the event that their insurance declines to reimburse the Company. In the absence of an agreement with the patient or other clearly enforceable legal right to demand payment from the patient, the related revenue is only recognized upon cash receipt. Estimates of amounts that the Company will ultimately realize require significant judgment by management. Some patients have out-of-pocket costs for amounts not covered by their insurance carrier, and the Company may bill the patient directly for these amounts in the form of co-payments and co-insurance in accordance with the patient’s health plan. Some payers may not cover the OVA1 and Overa tests as ordered by the prescribing physician under their reimbursement policies. The Company pursues reimbursement from such patients on a case-by-case basis. In the absence of contracted reimbursement coverage or the ability to estimate the amount that will ultimately be realized for the Company's services, revenue is recognized when cash is received. See discussion of ASU No. 2014-09 (defined below) included in Recent Accounting Pronouncements below. <p style="margin:0pt 0pt 2.25pt;line-height:normal;text-align:justify;text-justify:inter-ideograph;border-top:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;font-family:Arial Unicode MS;font-size: 10pt"> Service Revenue The Company’s service revenue is generated by performing IVD trial services for third-party customers. In accordance with SAB Topic 13, service revenue is recognized when the following revenue recognition criteria are met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the fee is fixed or determinable; and (4) collectability is reasonably assured.  See discussion of ASU No. 2014-09 included in Recent Accounting Pronouncements below. The Company has made no other significant changes in its critical accounting policies and estimates from those disclosed in the 2016 Annual Report.  Recent Accounting Pronouncements In March 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting (Topic 718), Compensation - Stock Compensation (“ASU 2016-09”). The new guidance simplifies several aspects of the accounting for share-based payments, including immediate recognition of all excess tax benefits and deficiencies in the income statement, changing the threshold to qualify for equity classification up to the employees' maximum statutory tax rates, allowing an entity-wide accounting policy election to either estimate the number of awards that are expected to vest or account for forfeitures as they occur, and clarifying the classification on the statement of cash flows for the excess tax benefit and employee taxes paid when an employer withholds shares for tax-withholding purposes. ASU 2016-09 is effective for annual reporting periods beginning after December 15, 2016 and interim periods within that reporting period. The adoption of this standard is not expected to have a material effect on our financial statements. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”), which removes inconsistencies and weaknesses in revenue requirements, provides a more robust framework for addressing revenue issues, improves comparability of revenue recognition practices across entities, industries, jurisdictions and capital markets, provides more useful information to users of financial statements through improved disclosure requirements and simplifies the preparation of financial statements by reducing the number of requirements to which an entity must refer. This guidance requires that an entity depict the consideration by applying a five-step analysis in determining when and how revenue is recognized. The new model will require revenue recognition to depict the transfer of promised goods or services to customers in an amount that reflects the consideration a company expects to receive in exchange for those goods or services. On April 1, 2015, the FASB voted for a one-year deferral of the effective date of the new revenue recognition standard, ASU No. 2014-09. On July 15, 2015, the FASB affirmed these changes, which requires public entities to apply the amendments in ASU 2014-09 for annual reporting beginning after December 15, 2017. Early adoption is permitted beginning after December 31, 2016, the original effective date in ASU 2014-09. The Company is in the early stages of its analysis of the effect ASU 2014-09 will have on its Service Revenue, but expects to complete its analysis during the fourth quarter of 2017. The Company is also continuing its analysis of the effect ASU 2014-09 will have on its Product Revenue and also expects to complete this analysis in the fourth quarter of 2017. Revenue that is recognized upon the ultimate receipt of cash under the Company’s existing revenue recognition policy will have to be reassessed under the new standard. The Company’s implementation process is to review its patient account population to determine the appropriate distribution of patient accounts by payer  (i.e., Medicare, patient pay, other third-party payer, etc.) into portfolios with similar collection experience that, when evaluated for collectability, will result in a materially consistent revenue amount for such portfolios as if each patient account were evaluated on a contract-by-contract basis. The Company has not yet determined if it plans to utilize the full retrospective or modified retrospective method of adoption, but anticipates adopting the new standard in the first quarter of 2018. </div> </div> 11000 34000 32000 29000 32000 85000 57500 125000 1240000 56000 498000 175000 1967000 2000000 5127000 5127000 3577000 3577000 3577000 5000 135000 1911000 1364000 58000 73000 136000 22000 25000 1868000 370000 685000 192000 -385556000 -393098000 <div> <div style="margin-left:0pt;margin-right:0pt;"> Revenue Recognition <p style="margin:0pt 0pt 2.25pt 10pt;line-height:normal;text-indent: -10pt;text-align:justify;text-justify:inter-ideograph;border-top:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;font-family:Arial Unicode MS;font-size: 10pt"> <p style="margin:0pt 0pt 2.25pt 10pt;line-height:normal;text-indent: -10pt;text-align:justify;text-justify:inter-ideograph;border-top:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;font-family:Arial Unicode MS;font-size: 10pt"> Product Revenue <p style="margin:0pt 0pt 2.25pt 10pt;line-height:normal;text-indent: -10pt;text-align:justify;text-justify:inter-ideograph;border-top:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;font-family:Arial Unicode MS;font-size: 8pt">         <font style="display: inline;font-family:Times New Roman;color:#000000;font-size:10pt;background-color: #FFFFFF;;font-size: 10pt;font-family:Arial Unicode MS;text-indent:0pt;margin-left:0pt;padding:0pt 36pt 0pt 0pt;">The Company has adopted ASC 954-605, Health Care Entities—Revenue Recognition, as revenue from laboratory services has become significant to the Company. The Company's product revenue is generated by performing diagnostic services using its OVA1 and Overa tests, and the service is completed upon the delivery of test results to the prescribing physician. The Company recognizes revenue related to billings for Medicare and commercial payers on an accrual basis, net of contractual and other adjustments, when amounts that will ultimately be realized can be estimated. Until a contract has been negotiated with a commercial payer or governmental program, the OVA1 and Overa tests may or may not be covered by these entities' existing reimbursement policies. In addition, patients do not enter into direct agreements with the Company that commit them to pay any portion of the cost of the tests in the event that their insurance declines to reimburse the Company. In the absence of an agreement with the patient or other clearly enforceable legal right to demand payment from the patient, the related revenue is only recognized upon cash receipt. Estimates of amounts that the Company will ultimately realize require significant judgment by management. Some patients have out-of-pocket costs for amounts not covered by their insurance carrier, and the Company may bill the patient directly for these amounts in the form of co-payments and co-insurance in accordance with the patient’s health plan. Some payers may not cover the OVA1 and Overa tests as ordered by the prescribing physician under their reimbursement policies. The Company pursues reimbursement from such patients on a case-by-case basis. In the absence of contracted reimbursement coverage or the ability to estimate the amount that will ultimately be realized for the Company's services, revenue is recognized when cash is received. See discussion of ASU No. 2014-09 (defined below) included in Recent Accounting Pronouncements below. <p style="margin:0pt 0pt 2.25pt;line-height:normal;text-align:justify;text-justify:inter-ideograph;border-top:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;font-family:Arial Unicode MS;font-size: 10pt"> Service Revenue The Company’s service revenue is generated by performing IVD trial services for third-party customers. In accordance with SAB Topic 13, service revenue is recognized when the following revenue recognition criteria are met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the fee is fixed or determinable; and (4) collectability is reasonably assured.  See discussion of ASU No. 2014-09 included in Recent Accounting Pronouncements below. The Company has made no other significant changes in its critical accounting policies and estimates from those disclosed in the 2016 Annual Report.  </div> </div> 1837000 623000 2323000 699000 66000 24000 94000 30000 1640000 581000 2195000 657000 197000 42000 128000 42000 <div> <div style="margin-left:0pt;margin-right:0pt;"> <div style="width:100%"><table cellpadding="0" cellspacing="0" style="border-collapse:collapse;width: 100.00%;margin-left:0pt;"> <tr> <td valign="bottom" style="width:38.88%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;"> </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;">   </td> <td valign="bottom" style="width:12.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;">   </td> <td valign="bottom" style="width:11.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;">   </td> <td valign="bottom" style="width:12.70%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;">   </td> <td valign="bottom" style="width:11.04%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:1.00pt;padding:0pt;">   </td> </tr> <tr> <td valign="bottom" style="width:38.88%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:24.75pt;padding:0pt;"> </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:24.75pt;padding:0pt;">   </td> <td colspan="5" valign="bottom" style="width:00.02%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:24.75pt;padding:0pt;"> Three Months Ended September 30, </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:24.75pt;padding:0pt;">   </td> <td colspan="5" valign="bottom" style="width:00.02%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:24.75pt;padding:0pt;"> Nine Months Ended September 30, </td> </tr> <tr> <td valign="top" style="width:38.88%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:12.75pt;padding:0pt;"> (in thousands) </td> <td valign="top" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:12.75pt;padding:0pt;">   </td> <td colspan="2" valign="bottom" style="width:00.02%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:12.75pt;padding:0pt;"> 2017 </td> <td valign="bottom" style="width:01.82%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:12.75pt;padding:0pt;">   </td> <td colspan="2" valign="bottom" style="width:00.02%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:12.75pt;padding:0pt;"> 2016 </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:12.75pt;padding:0pt;">   </td> <td colspan="2" valign="bottom" style="width:00.02%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:12.75pt;padding:0pt;"> 2017 </td> <td valign="bottom" style="width:01.82%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:12.75pt;padding:0pt;">   </td> <td colspan="2" valign="bottom" style="width:00.02%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;background-color: #auto;height:12.75pt;padding:0pt;"> 2016 </td> </tr> <tr> <td valign="bottom" style="width:38.88%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;"> Cost of revenue </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;"> $ </td> <td valign="bottom" style="width:12.86%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">21  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;"> $ </td> <td valign="bottom" style="width:11.80%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">24  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;"> $ </td> <td valign="bottom" style="width:12.70%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">61  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;"> $ </td> <td valign="bottom" style="width:11.04%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">70  </td> </tr> <tr> <td valign="bottom" style="width:38.88%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;"> Research and development </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:12.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">  — </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:11.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">10  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:12.70%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">5  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:11.04%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">63  </td> </tr> <tr> <td valign="bottom" style="width:38.88%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;"> Sales and marketing </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:12.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">38  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:11.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">10  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:12.70%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">108  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:11.04%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">66  </td> </tr> <tr> <td valign="bottom" style="width:38.88%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;"> General and administrative </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:12.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">216  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:11.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">198  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:12.70%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">630  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:11.04%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">623  </td> </tr> <tr> <td valign="bottom" style="width:38.88%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;"> Total </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;"> $ </td> <td valign="bottom" style="width:12.86%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">275  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;"> $ </td> <td valign="bottom" style="width:11.80%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">242  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;"> $ </td> <td valign="bottom" style="width:12.70%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">804  </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;padding:0pt;"> $ </td> <td valign="bottom" style="width:11.04%;border-top:1pt solid #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;background-color: #CCEEFF;height:12.75pt;color:#000000;font-family:Times New Roman;font-size:10pt;text-align:right;" nowrap="nowrap">822  </td> </tr> <tr> <td valign="bottom" style="width:38.88%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;"> </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:2pt double #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:12.86%;border-top:2pt double #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:2pt double #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:11.80%;border-top:2pt double #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:2pt double #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:12.70%;border-top:2pt double #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.82%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:01.36%;border-top:2pt double #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> <td valign="bottom" style="width:11.04%;border-top:2pt double #000000 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt none #D9D9D9 ;border-right:1pt none #D9D9D9 ;height:12.75pt;padding:0pt;">   </td> </tr> </table></div> </div> </div> 5514000 1606000 3114000 1050000 861000 997000 0.25 0.25 0.5 0.25 0.25 0.25 0.24 0.25 27878 1.32 2.14 2.14 1.32 1.83 2.14 131250 5037 0 8122983 70000 916000 14500 250000 120000 22500 182000 191000 3762000 5921000 48000 942000 942000 942000 52167543 52237287 55909788 57455786 3796818 2000000 0.05 40 P2Y 942000 804000 <div> <div style="margin-left:0pt;margin-right:0pt;"> Going Concern The Company has incurred significant net losses and negative cash flows from operations since inception, and as a result has an accumulated deficit of approximately $393,098,000 at September 30, 2017. The Company also expects to incur a net loss and negative cash flows from operations for the remainder of 2017 and the foreseeable future. The Company’s management believes that successful achievement of the Company’s business objectives will require additional financing. Given these conditions, there is substantial doubt about the Company’s ability to continue as a going concern. The condensed consolidated financial statements have been prepared on a going concern basis and do not include any adjustments that might result from these uncertainties. The Company expects to raise capital through a variety of sources, which may include the exercise of common stock warrants, equity offerings, debt financing, collaborations, licensing arrangements, grants and government funding and strategic alliances. However, additional funding may not be available when needed or on terms acceptable to the Company. If the Company is unable to obtain additional capital, it may not be able to continue sales and marketing, research and development, or other operations on the scope or scale of current activity and that could have a material adverse effect on the Company’s business, results of operations and financial condition. As discussed in Note 4, on August 31, 2017, certain investors exercised outstanding warrants for common stock for net proceeds of approximately $3,577,000 after deducting offering expenses. As discussed in Note 4, on February 17, 2017, the Company completed a private placement pursuant to which certain investors purchased Vermillion common stock and warrants to purchase shares of Vermillion common stock for net proceeds of approximately $5,127,000 after deducting offering expenses. As discussed in Note 3, in March 2016, the Company entered into an agreement (the “Loan Agreement”) pursuant to which it may borrow up to $4,000,000 from the State of Connecticut Department of Economic and Community Development (the “DECD”). An initial disbursement of $2,000,000 was made to the Company in April 2016 under the Loan Agreement. The Loan Agreement provides that the remaining $2,000,000 will be disbursed if and when the Company achieves certain future milestones.  </div> </div> 3796818 P5M P36M 1 95000 46000 <div> <div style="margin-left:0pt;margin-right:0pt;"> Organization Vermillion, Inc. (“Vermillion”; Vermillion and its wholly-owned subsidiaries are collectively referred to as the “Company<a name="_cp_text_1_15"></a>,” “we” or “our”) is incorporated in the state of Delaware, and is engaged in the business of developing and commercializing diagnostic tests for gynecologic disease. The Company sells OVA1™ and Overa™ risk of malignancy tests for ovarian cancer (“OVA1” and “Overa,” respectively) through Vermillion’s wholly-owned Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) certified clinical laboratory, ASPiRA LABS, Inc. (“ASPiRA LABS”). The Company also offers in-vitro diagnostic (“IVD”) trial services to third-party customers through its wholly-owned subsidiary, ASPiRA IVD, Inc. (“ASPiRA IVD”), which commenced operations in June 2016. ASPiRA IVD is a specialized, CLIA certified, laboratory provider dedicated to meeting the unique testing needs of IVD manufacturers seeking to commercialize high-complexity assays. </div> </div> 0.04 0.125 281000 9000 <div> <div style="margin-left:0pt;margin-right:0pt;"> Significant Accounting and Reporting Policies </div> </div> 4166659 Cost of revenue $29, $27, $108, $73 General and administrative $257, $210, $767, $655 Research and development $2, $10, $7, $63 Sales and marketing $38, $14, $115, $70 EX-101.SCH 7 vrml-20170930.xsd EX-101.SCH 00100 - Statement - Condensed Consolidated Balance Sheets link:presentationLink link:calculationLink link:definitionLink 00200 - Statement - Condensed Consolidated Statements Of Operations link:presentationLink link:calculationLink link:definitionLink 00400 - Statement - Condensed Consolidated Statements Of Cash Flows link:presentationLink link:calculationLink link:definitionLink 00090 - Document - Document and Entity Information link:presentationLink link:calculationLink link:definitionLink 00105 - 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Document and Entity Information - shares
9 Months Ended

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Oct. 31, 2017

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Document Period End Date Sep. 30, 2017

Document Fiscal Year Focus 2017

Document Fiscal Period Focus Q3

Entity Registrant Name VERMILLION, INC.

Entity Central Index Key 0000926617

Current Fiscal Year End Date --12-31

Entity Filer Category Smaller Reporting Company

Entity Common Stock, Shares Outstanding 59,998,748

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Condensed Consolidated Balance Sheets - USD ($)

Sep. 30, 2017

Dec. 31, 2016

Current assets:

Cash and cash equivalents $ 7,752,000 $ 5,242,000

Accounts receivable 221,000 275,000

Prepaid expenses and other current assets 175,000 498,000

Inventories 155,000 93,000

Total current assets 8,303,000 6,108,000

Property and equipment, net 1,364,000 1,911,000

Other assets 11,000

Total assets 9,678,000 8,019,000

Current liabilities:

Accounts payable 514,000 881,000

Accrued liabilities 1,430,000 1,464,000

Deferred revenue 62,000

Short-term debt 191,000 182,000

Other current liabilities 32,000 34,000

Total current liabilities 2,229,000 2,561,000

Non-current liabilities:

Long-term debt 1,528,000 1,667,000

Other non-current liabilities 29,000

Total liabilities 3,757,000 4,257,000

Commitments and contingencies (Note 3)

Stockholders' equity:

Common stock, par value $0.001 per share, 150,000,000 shares authorized at September 30, 2017 and December 31, 2016; 59,998,748 and 52,328,492 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively 60,000 52,000

Additional paid-in capital 398,959,000 389,266,000

Accumulated deficit (393,098,000) (385,556,000)

Total stockholders' equity 5,921,000 3,762,000

Total liabilities and stockholders' equity $ 9,678,000 $ 8,019,000

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Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares

Sep. 30, 2017

Dec. 31, 2016

Condensed Consolidated Balance Sheets [Abstract]

Common stock, par value $ 0.001 $ 0.001

Common stock, shares authorized 150,000,000 150,000,000

Common stock, shares issued 59,998,748 52,328,492

Common stock, shares outstanding 59,998,748 52,328,492

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Condensed Consolidated Statements Of Operations - USD ($)
3 Months Ended 9 Months Ended

Sep. 30, 2017

Sep. 30, 2016

Sep. 30, 2017

Sep. 30, 2016

Revenue:

Product $ 657,000 $ 581,000 $ 2,195,000 $ 1,640,000

Service 42,000 42,000 128,000 197,000

Total revenue 699,000 623,000 2,323,000 1,837,000

Cost of revenue:

Product ^[1] 495,000 461,000 1,345,000 1,516,000

Service ^[1] 284,000 356,000 855,000 416,000

Total cost of revenue ^[1] 779,000 817,000 2,200,000 1,932,000

Gross profit (loss) (80,000) (194,000) 123,000 (95,000)

Operating expenses:

Research and development ^[2] 192,000 370,000 685,000 1,868,000

Sales and marketing ^[3] 1,050,000 1,606,000 3,114,000 5,514,000

General and administrative ^[4] 1,177,000 1,295,000 3,825,000 4,645,000

Total operating expenses 2,419,000 3,271,000 7,624,000 12,027,000

Loss from operations (2,499,000) (3,465,000) (7,501,000) (12,122,000)

Interest income (expense), net (10,000) (11,000) (32,000) (16,000)

Other income (expense), net (9,000) 16,000

Net loss (2,509,000) (3,476,000) (7,542,000) (12,122,000)

Deemed dividend on warrant repricing (942,000) (942,000)

Net loss attributable to common stockholders $ (3,451,000) $ (3,476,000) $ (8,484,000) $ (12,122,000)

Net loss per share attributable to common stockholders - basic and diluted $ (0.06) $ (0.07) $ (0.15) $ (0.23)

Weighted average common shares used to compute basic and diluted net loss per common share 57,455,786 52,237,287 55,909,788 52,167,543

[1] Cost of revenue $29, $27, $108, $73

[2] Research and development $2, $10, $7, $63

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Organization, Basis Of Presentation And Significant Accounting And Reporting Policies
9 Months Ended

Sep. 30, 2017

Organization, Basis Of Presentation And Significant Accounting And Reporting Policies [Abstract]

Organization, Basis Of Presentation And Significant Accounting And Reporting Policies

1. ORGANIZATION, BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING AND REPORTING POLICIES

Organization

Vermillion, Inc. (“Vermillion”; Vermillion and its wholly-owned subsidiaries are collectively referred to as the “Company,” “we” or “our”) is incorporated in the state of Delaware, and is engaged in the business of developing and commercializing diagnostic tests for gynecologic disease. The Company sells OVA1™ and Overa™ risk of malignancy tests for ovarian cancer (“OVA1” and “Overa,” respectively) through Vermillion’s wholly-owned Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) certified clinical laboratory, ASPiRA LABS, Inc. (“ASPiRA LABS”).

The Company also offers in-vitro diagnostic (“IVD”) trial services to third-party customers through its wholly-owned subsidiary, ASPiRA IVD, Inc. (“ASPiRA IVD”), which commenced operations in June 2016. ASPiRA IVD is a specialized, CLIA certified, laboratory provider dedicated to meeting the unique testing needs of IVD manufacturers seeking to commercialize high-complexity assays.

Going Concern

The Company has incurred significant net losses and negative cash flows from operations since inception, and as a result has an accumulated deficit of approximately $393,098,000 at September 30, 2017. The Company also expects to incur a net loss and negative cash flows from operations for the remainder of 2017 and the foreseeable future. The Company’s management believes that successful achievement of the Company’s business objectives will require additional financing. Given these conditions, there is substantial doubt about the Company’s ability to continue as a going concern. The condensed consolidated financial statements have been prepared on a going concern basis and do not include any adjustments that might result from these uncertainties.

The Company expects to raise capital through a variety of sources, which may include the exercise of common stock warrants, equity offerings, debt financing, collaborations, licensing arrangements, grants and government funding and strategic alliances. However, additional funding may not be available when needed or on terms acceptable to the Company. If the Company is unable to obtain additional capital, it may not be able to continue sales and marketing, research and development, or other operations on the scope or scale of current activity and that could have a material adverse effect on the Company’s business, results of operations and financial condition.

As discussed in Note 4, on August 31, 2017, certain investors exercised outstanding warrants for common stock for net proceeds of approximately $3,577,000 after deducting offering expenses.

As discussed in Note 4, on February 17, 2017, the Company completed a private placement pursuant to which certain investors purchased Vermillion common stock and warrants to purchase shares of Vermillion common stock for net proceeds of approximately $5,127,000 after deducting offering expenses.

As discussed in Note 3, in March 2016, the Company entered into an agreement (the “Loan Agreement”) pursuant to which it may borrow up to $4,000,000 from the State of Connecticut Department of Economic and Community Development (the “DECD”). An initial disbursement of $2,000,000 was made to the Company in April 2016 under the Loan Agreement. The Loan Agreement provides that the remaining $2,000,000 will be disbursed if and when the Company achieves certain future milestones.

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8-03 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management of the Company, all adjustments, consisting of normal recurring adjustments necessary for the fair statement of results for the periods presented, have been included. The results of operations of any interim period are not necessarily indicative of the results of operations for the full year or any other interim period.

The unaudited condensed consolidated financial statements and related disclosures have been prepared with the presumption that users of the interim unaudited condensed consolidated financial statements have read or have access to the audited consolidated financial statements for the preceding fiscal year. The condensed consolidated balance sheet at December 31, 2016 included in this report has been derived from the audited consolidated financial statements at that date but does not include all the information and footnotes required by GAAP. Accordingly, these unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2016 included in Vermillion’s Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on March 31, 2017 (the “2016 Annual Report”).

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimated results.

Significant Accounting and Reporting Policies

Revenue Recognition

Product Revenue

 The Company has adopted ASC 954-605, Health Care Entities—Revenue Recognition, as revenue from laboratory services has become significant to the Company. The Company's product revenue is generated by performing diagnostic services using its OVA1 and Overa tests, and the service is completed upon the delivery of test results to the prescribing physician. The Company recognizes revenue related to billings for Medicare and commercial payers on an accrual basis, net of contractual and other adjustments, when amounts that will ultimately be realized can be estimated. Until a contract has been negotiated with a commercial payer or governmental program, the OVA1 and Overa tests may or may not be covered by these entities' existing reimbursement policies. In addition, patients do not enter into direct agreements with the Company that commit them to pay any portion of the cost of the tests in the event that their insurance declines to reimburse the Company. In the absence of an agreement with the patient or other clearly enforceable legal right to demand payment from the patient, the related revenue is only recognized upon cash receipt.

Estimates of amounts that the Company will ultimately realize require significant judgment by management. Some patients have out-of-pocket costs for amounts not covered by their insurance carrier, and the Company may bill the patient directly for these amounts in the form of co-payments and co-insurance in accordance with the patient’s health plan. Some payers may not cover the OVA1 and Overa tests as ordered by the prescribing physician under their reimbursement policies. The Company pursues reimbursement from such patients on a case-by-case basis. In the absence of contracted reimbursement coverage or the ability to estimate the amount that will ultimately be realized for the Company's services, revenue is recognized when cash is received.

See discussion of ASU No. 2014-09 (defined below) included in Recent Accounting Pronouncements below.

Service Revenue

The Company’s service revenue is generated by performing IVD trial services for third-party customers. In accordance with SAB Topic 13, service revenue is recognized when the following revenue recognition criteria are met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the fee is fixed or determinable; and (4) collectability is reasonably assured.

See discussion of ASU No. 2014-09 included in Recent Accounting Pronouncements below.

The Company has made no other significant changes in its critical accounting policies and estimates from those disclosed in the 2016 Annual Report.

Recent Accounting Pronouncements

In March 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting (Topic 718), Compensation - Stock Compensation (“ASU 2016-09”). The new guidance simplifies several aspects of the accounting for share-based payments, including immediate recognition of all excess tax benefits and deficiencies in the income statement, changing the threshold to qualify for equity classification up to the employees' maximum statutory tax rates, allowing an entity-wide accounting policy election to either estimate the number of awards that are expected to vest or account for forfeitures as they occur, and clarifying the classification on the statement of cash flows for the excess tax benefit and employee taxes paid when an employer withholds shares for tax-withholding purposes. ASU 2016-09 is effective for annual reporting periods beginning after December 15, 2016 and interim periods within that reporting period. The adoption of this standard is not expected to have a material effect on our financial statements.

In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”), which removes inconsistencies and weaknesses in revenue requirements, provides a more robust framework for addressing revenue issues, improves comparability of revenue recognition practices across entities, industries, jurisdictions and capital markets, provides more useful information to users of financial statements through improved disclosure requirements and simplifies the preparation of financial statements by reducing the number of requirements to which an entity must refer. This guidance requires that an entity depict the consideration by applying a five-step analysis in determining when and how revenue is recognized. The new model will require revenue recognition to depict the transfer of promised goods or services to customers in an amount that reflects the consideration a company expects to receive in exchange for those goods or services. On April 1, 2015, the FASB voted for a one-year deferral of the effective date of the new revenue recognition standard, ASU No. 2014-09. On July 15, 2015, the FASB affirmed these changes, which requires public entities to apply the amendments in ASU 2014-09 for annual reporting beginning after December 15, 2017. Early adoption is permitted beginning after December 31, 2016, the original effective date in ASU 2014-09.

The Company is in the early stages of its analysis of the effect ASU 2014-09 will have on its Service Revenue, but expects to complete its analysis during the fourth quarter of 2017.

The Company is also continuing its analysis of the effect ASU 2014-09 will have on its Product Revenue and also expects to complete this analysis in the fourth quarter of 2017. Revenue that is recognized upon the ultimate receipt of cash under the Company’s existing revenue recognition policy will have to be reassessed under the new standard. The Company’s implementation process is to review its patient account population to determine the appropriate distribution of patient accounts by payer (i.e., Medicare, patient pay, other third-party payer, etc.) into portfolios with similar collection experience that, when evaluated for collectability, will result in a materially consistent revenue amount for such portfolios as if each patient account were evaluated on a contract-by-contract basis.

The Company has not yet determined if it plans to utilize the full retrospective or modified retrospective method of adoption, but anticipates adopting the new standard in the first quarter of 2018.

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Agreements With Quest Diagnostics Incorporated
9 Months Ended

Sep. 30, 2017

Agreements With Quest Diagnostics Incorporated [Abstract]

Agreements With Quest Diagnostics Incorporated

2. AGREEMENTS WITH QUEST DIAGNOSTICS INCORPORATED

In March 2015, the Company entered into a commercial agreement with Quest Diagnostics, Incorporated (“Quest Diagnostics”). Pursuant to this agreement, all OVA1 U.S. testing services for Quest Diagnostics customers were transferred to Vermillion’s wholly-owned subsidiary, ASPiRA LABS, as of August 2015. Pursuant to this agreement, as amended as of March 11, 2017, Quest Diagnostics has agreed to provide blood draw and logistics support by transporting specimens from its clients to ASPiRA LABS for testing through at least March 11, 2018 in exchange for a market value fee. Per the terms of this agreement, the Company will not offer to existing or future Quest Diagnostics customers tests that Quest Diagnostics offers.

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Commitments And Contingencies
9 Months Ended

Sep. 30, 2017

Commitments And Contingencies [Abstract]

Commitments And Contingencies

3. COMMITMENTS AND CONTINGENCIES

Development Loan

On March 22, 2016, the Company entered into the Loan Agreement, pursuant to which the Company may borrow up to $4,000,000 from the DECD. Proceeds from the $2,000,000 April 2016 initial disbursement under the Loan Agreement were utilized primarily to fund the build-out, information technology infrastructure and other costs related to the Company’s Trumbull, Connecticut facility and operations. The loan bears interest at a fixed rate of 2.0% per annum and requires equal monthly payments of principal and interest until maturity, which occurs on April 15, 2026. As security for the loan, the Company has granted the DECD a blanket security interest in the Company’s personal and intellectual property. The DECD’s security interest in the Company’s intellectual property may be subordinated to a qualified institutional lender. Under the terms of the Loan Agreement, the Company may be eligible for forgiveness of up to $2,000,000 of the principal amount of the loan if the Company achieves certain job creation and retention milestones by March 1, 2018. Conversely, if the Company is unable to meet these job creation milestones, namely, hiring 40 full-time employees with a specified average annual salary within the allotted timeframe and retaining those employees for a two-year period or does not maintain the Company’s Connecticut operations for a period of 10 years, the DECD may require early repayment of a portion or all of the loan plus a penalty of 5%.

As discussed above, an initial disbursement of $2,000,000 was made to the Company on April 15, 2016 under the Loan Agreement. The Loan Agreement provides that the remaining $2,000,000 will be disbursed if and when the Company achieves certain future milestones. The loan may be prepaid at any time without premium or penalty .

Operating Leases

The Company leases facilities to support its business of discovering, developing and commercializing diagnostic tests in the fields of gynecologic disease. The Company’s principal facility, including the CLIA laboratory used by ASPiRA LABS, is located in Austin, Texas, and the CLIA laboratory used by ASPiRA IVD is located in Trumbull, Connecticut. The Austin, Texas lease includes an aggregate annual base rent of $85,000 and annual estimated common area charges, taxes and insurance of $46,000 and expires on January 31, 2019.

In October 2015, the Company entered into a lease agreement for a facility in Trumbull, Connecticut. The lease required initial payments for the buildout of leasehold improvements to the office space, which were approximately $596,000. The term of the lease is five years beginning after the initial date of occupancy in January 2016 and a rent abatement period of five months. The lease includes an aggregate annual base rent of $32,000 and annual estimated common area charges, taxes and insurance of $95,000.

Building rent for the three months ended September 30, 2017 and 2016 totaled $66,000 and $71,000, respectively. Building rent for the nine months ended September 30, 2017 and 2016 totaled $189,000 and $175,000, respectively.

Capital Lease

In April 2015, the Company leased a laboratory instrument for a total initial payment of $125,000 and ongoing payments of approximately $3,500 per month for 36 months after delivery. The agreement also requires minimum annual purchases of reagents from the manufacturer of the equipment. The laboratory instrument was placed into service on July 1, 2015.

The accumulated amortization of assets under capital lease obligations was $174,000 and $97,000 as of September 30, 2017 and 2016, respectively. The net book value of assets under capital lease obligations was $58,000 and $135,000 as of September 30, 2017 and 2016, respectively.

Non-cancelable Royalty Obligations

The Company is a party to an amended research collaboration agreement with The Johns Hopkins University School of Medicine under which the Company licenses certain of its intellectual property. Under the terms of the amended research collaboration agreement, Vermillion is required to pay the greater of 4% royalties on net sales of diagnostic tests using the assigned patents or annual minimum royalties of $57,500. Royalty expense for the three months ended September 30, 2017 and 2016 totalled $30,000 and $24,000, respectively. Royalty expense for the nine months ended September 30, 2017 and 2016 totalled $94,000 and $66,000, respectively.



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Stockholders' Equity
9 Months Ended

Sep. 30, 2017

Stockholders' Equity [Abstract]

Stockholders' Equity

4. STOCKHOLDERS’ EQUITY

2017 Warrant Repricing and Exercise

In December 2014, the Company issued warrants to purchase up to an aggregate of 4,166,659 shares of Vermillion common stock at an exercise price of $2.00 per share in conjunction with a December 2014 private placement of Vermillion common stock. The warrants expire by their original terms on December 23, 2017.

On August 31, 2017, certain holders exercised warrants to purchase 3,796,818 shares of Vermillion common stock in consideration for the Company agreeing to reduce the exercise price to $1.00 per share of Vermillion common stock.

The Company issued 3,796,818 shares of Vermillion common stock and received $3,796,818 in aggregate gross proceeds (approximately $3,577,000 net of transaction costs). The incremental non-cash fair value of approximately $942,000 from the modification of the warrants was calculated using the Black-Scholes model and recorded as a deemed dividend to the warrant holders within stockholders’ equity.

2017 Private Placement

On February 17, 2017, the Company completed a private placement pursuant to which certain investors purchased 3,747,125 shares of Vermillion common stock at a price of $1.40 per share. Vermillion also issued warrants to purchase shares of Vermillion common stock at a price of $0.125 per warrant share in the private placement. Net proceeds of the private placement were approximately $5,127,000 after deducting offering expenses. The warrants are exercisable for 2,810,338 shares of Vermillion common stock at $1.80 per share. The warrants expire on the fifth anniversary of the date of issuance or, if earlier, five business days after Vermillion delivers notice that the closing price per share of its common stock exceeded the exercise price for 20 consecutive trading days during the exercise period.

The sale of common stock and issuance of warrants qualified for equity treatment under GAAP. The respective values of the warrants and common stock were calculated using their relative fair values and classified under common stock and additional paid-in capital. The value ascribed to the warrants is $804,000 and to the common stock is approximately $4,296,000.

2010 Stock Incentive Plan

The Company’s employees, directors, and consultants are eligible to receive awards under the Vermillion, Inc. Second Amended and Restated 2010 Stock Incentive Plan (the “2010 Plan”). The 2010 Plan permits the granting of a variety of awards, including stock options, share appreciation rights, restricted shares, restricted share units, unrestricted shares, deferred share units, performance and cash-settled awards, and dividend equivalent rights. The 2010 Plan provides for issuance of up to 8,122,983 shares of Vermillion common stock, subject to adjustment as provided in the 2010 Plan.

Stock-Based Compensation

During the nine months ended September 30, 2017, the Company awarded to Vermillion’s non-employee directors 131,250 shares of restricted stock under the 2010 Plan having a fair value of approximately $281,000 as payment for services to be rendered in 2017. These shares of restricted stock vested 50% on June 1, 2017 and 25% on September 1, 2017, and the remaining 25% will vest on December 1, 2017. The Company also issued to certain consultants 27,878 shares of restricted stock under the 2010 Plan having a fair value of approximately $48,000.

During the three months ended September 30, 2017, the Company issued to certain consultants 5,037 shares of restricted stock under the 2010 Plan having a fair value of approximately $9,000. The Company did not make any awards of restricted stock to non-employee directors during the three months ended September 30, 2017.

During the nine months ended September 30, 2017, the Company also granted certain consultants options to purchase 70,000 shares of Vermillion common stock with an exercise price of $2.14 per share. The Company also granted certain officers and employees options to purchase approximately 916,000 shares of Vermillion common stock with an exercise price of $2.14 per share. In addition, the Company granted certain officers and employees options to purchase 14,500 shares of Vermillion common stock with an exercise price of $1.83 per share. These stock options generally vest 25% on each of the four anniversaries of the grant date.

During the nine months ended September 30, 2017, the Company also granted certain officers and employees options to purchase 250,000 shares of Vermillion common stock with an exercise price of approximately $2.14 per share with performance-based vesting based on certain metrics through December 31, 2017. These options vest 25% on each of the four anniversaries of the grant date if the performance-based metrics are met.

During the three months ended September 30, 2017, the Company granted certain officers and employees options to purchase 22,500 shares of Vermillion common stock with an exercise price of $1.32 per share. These stock options vest 25% on each of the four anniversaries of the vesting commencement date for each such stock option.

During the three months ended September 30, 2017, the Company granted certain consultants of the Company options to purchase 120,000 shares of Vermillion common stock with an exercise price of $1.32 per share. These stock options vest in 24 equal monthly installments beginning on the vesting commencement date for each such stock option.

The allocation of employee stock-based compensation expense by functional area for the three and nine months ended September 30, 2017 and 2016 was as follows:

Three Months Ended September 30,

Nine Months Ended September 30,

(in thousands)

2017

2016

2017

2016

Cost of revenue

$
21

$
24

$
61

$
70

Research and development

—

10

5

63

Sales and marketing

38

10

108

66

General and administrative

216

198

630

623

Total

$
275

$
242

$
804

$
822

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Loss Per Share
9 Months Ended

Sep. 30, 2017

Loss Per Share [Abstract]

Loss Per Share

5. LOSS PER SHARE

The Company calculates basic loss per share using the weighted average number of shares of Vermillion common stock outstanding during the period. Because the Company is in a net loss position, diluted loss per share is calculated using the weighted average number of shares of Vermillion common stock outstanding and excludes the effects of 7,971,860 and 7,485,632 potential shares of Vermillion common stock as of September 30, 2017 and 2016, respectively, that are anti-dilutive. Potential shares of Vermillion common stock include incremental shares of Vermillion common stock issuable upon the exercise of outstanding warrants, stock options and unvested restricted stock units.

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Organization, Basis Of Presentation And Significant Accounting And Reporting Policies (Policy)
9 Months Ended

Sep. 30, 2017

Organization, Basis Of Presentation And Significant Accounting And Reporting Policies [Abstract]

Organization

Organization

Vermillion, Inc. (“Vermillion”; Vermillion and its wholly-owned subsidiaries are collectively referred to as the “Company,” “we” or “our”) is incorporated in the state of Delaware, and is engaged in the business of developing and commercializing diagnostic tests for gynecologic disease. The Company sells OVA1™ and Overa™ risk of malignancy tests for ovarian cancer (“OVA1” and “Overa,” respectively) through Vermillion’s wholly-owned Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) certified clinical laboratory, ASPiRA LABS, Inc. (“ASPiRA LABS”).

The Company also offers in-vitro diagnostic (“IVD”) trial services to third-party customers through its wholly-owned subsidiary, ASPiRA IVD, Inc. (“ASPiRA IVD”), which commenced operations in June 2016. ASPiRA IVD is a specialized, CLIA certified, laboratory provider dedicated to meeting the unique testing needs of IVD manufacturers seeking to commercialize high-complexity assays.

Going Concern

Going Concern

The Company has incurred significant net losses and negative cash flows from operations since inception, and as a result has an accumulated deficit of approximately $393,098,000 at September 30, 2017. The Company also expects to incur a net loss and negative cash flows from operations for the remainder of 2017 and the foreseeable future. The Company’s management believes that successful achievement of the Company’s business objectives will require additional financing. Given these conditions, there is substantial doubt about the Company’s ability to continue as a going concern. The condensed consolidated financial statements have been prepared on a going concern basis and do not include any adjustments that might result from these uncertainties.

The Company expects to raise capital through a variety of sources, which may include the exercise of common stock warrants, equity offerings, debt financing, collaborations, licensing arrangements, grants and government funding and strategic alliances. However, additional funding may not be available when needed or on terms acceptable to the Company. If the Company is unable to obtain additional capital, it may not be able to continue sales and marketing, research and development, or other operations on the scope or scale of current activity and that could have a material adverse effect on the Company’s business, results of operations and financial condition.

As discussed in Note 4, on August 31, 2017, certain investors exercised outstanding warrants for common stock for net proceeds of approximately $3,577,000 after deducting offering expenses.

As discussed in Note 4, on February 17, 2017, the Company completed a private placement pursuant to which certain investors purchased Vermillion common stock and warrants to purchase shares of Vermillion common stock for net proceeds of approximately $5,127,000 after deducting offering expenses.

As discussed in Note 3, in March 2016, the Company entered into an agreement (the “Loan Agreement”) pursuant to which it may borrow up to $4,000,000 from the State of Connecticut Department of Economic and Community Development (the “DECD”). An initial disbursement of $2,000,000 was made to the Company in April 2016 under the Loan Agreement. The Loan Agreement provides that the remaining $2,000,000 will be disbursed if and when the Company achieves certain future milestones.

Basis of Presentation

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8-03 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management of the Company, all adjustments, consisting of normal recurring adjustments necessary for the fair statement of results for the periods presented, have been included. The results of operations of any interim period are not necessarily indicative of the results of operations for the full year or any other interim period.

The unaudited condensed consolidated financial statements and related disclosures have been prepared with the presumption that users of the interim unaudited condensed consolidated financial statements have read or have access to the audited consolidated financial statements for the preceding fiscal year. The condensed consolidated balance sheet at December 31, 2016 included in this report has been derived from the audited consolidated financial statements at that date but does not include all the information and footnotes required by GAAP. Accordingly, these unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2016 included in Vermillion’s Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on March 31, 2017 (the “2016 Annual Report”).

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimated results.

Significant Accounting and Reporting Policies

Significant Accounting and Reporting Policies

Revenue Recognition

Revenue Recognition

Product Revenue

 The Company has adopted ASC 954-605, Health Care Entities—Revenue Recognition, as revenue from laboratory services has become significant to the Company. The Company's product revenue is generated by performing diagnostic services using its OVA1 and Overa tests, and the service is completed upon the delivery of test results to the prescribing physician. The Company recognizes revenue related to billings for Medicare and commercial payers on an accrual basis, net of contractual and other adjustments, when amounts that will ultimately be realized can be estimated. Until a contract has been negotiated with a commercial payer or governmental program, the OVA1 and Overa tests may or may not be covered by these entities' existing reimbursement policies. In addition, patients do not enter into direct agreements with the Company that commit them to pay any portion of the cost of the tests in the event that their insurance declines to reimburse the Company. In the absence of an agreement with the patient or other clearly enforceable legal right to demand payment from the patient, the related revenue is only recognized upon cash receipt.

Estimates of amounts that the Company will ultimately realize require significant judgment by management. Some patients have out-of-pocket costs for amounts not covered by their insurance carrier, and the Company may bill the patient directly for these amounts in the form of co-payments and co-insurance in accordance with the patient’s health plan. Some payers may not cover the OVA1 and Overa tests as ordered by the prescribing physician under their reimbursement policies. The Company pursues reimbursement from such patients on a case-by-case basis. In the absence of contracted reimbursement coverage or the ability to estimate the amount that will ultimately be realized for the Company's services, revenue is recognized when cash is received.

See discussion of ASU No. 2014-09 (defined below) included in Recent Accounting Pronouncements below.

Service Revenue

The Company’s service revenue is generated by performing IVD trial services for third-party customers. In accordance with SAB Topic 13, service revenue is recognized when the following revenue recognition criteria are met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the fee is fixed or determinable; and (4) collectability is reasonably assured.

See discussion of ASU No. 2014-09 included in Recent Accounting Pronouncements below.

The Company has made no other significant changes in its critical accounting policies and estimates from those disclosed in the 2016 Annual Report.

Recent Accounting Pronouncements

Recent Accounting Pronouncements

In March 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting (Topic 718), Compensation - Stock Compensation (“ASU 2016-09”). The new guidance simplifies several aspects of the accounting for share-based payments, including immediate recognition of all excess tax benefits and deficiencies in the income statement, changing the threshold to qualify for equity classification up to the employees' maximum statutory tax rates, allowing an entity-wide accounting policy election to either estimate the number of awards that are expected to vest or account for forfeitures as they occur, and clarifying the classification on the statement of cash flows for the excess tax benefit and employee taxes paid when an employer withholds shares for tax-withholding purposes. ASU 2016-09 is effective for annual reporting periods beginning after December 15, 2016 and interim periods within that reporting period. The adoption of this standard is not expected to have a material effect on our financial statements.

In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”), which removes inconsistencies and weaknesses in revenue requirements, provides a more robust framework for addressing revenue issues, improves comparability of revenue recognition practices across entities, industries, jurisdictions and capital markets, provides more useful information to users of financial statements through improved disclosure requirements and simplifies the preparation of financial statements by reducing the number of requirements to which an entity must refer. This guidance requires that an entity depict the consideration by applying a five-step analysis in determining when and how revenue is recognized. The new model will require revenue recognition to depict the transfer of promised goods or services to customers in an amount that reflects the consideration a company expects to receive in exchange for those goods or services. On April 1, 2015, the FASB voted for a one-year deferral of the effective date of the new revenue recognition standard, ASU No. 2014-09. On July 15, 2015, the FASB affirmed these changes, which requires public entities to apply the amendments in ASU 2014-09 for annual reporting beginning after December 15, 2017. Early adoption is permitted beginning after December 31, 2016, the original effective date in ASU 2014-09.

The Company is in the early stages of its analysis of the effect ASU 2014-09 will have on its Service Revenue, but expects to complete its analysis during the fourth quarter of 2017.

The Company is also continuing its analysis of the effect ASU 2014-09 will have on its Product Revenue and also expects to complete this analysis in the fourth quarter of 2017. Revenue that is recognized upon the ultimate receipt of cash under the Company’s existing revenue recognition policy will have to be reassessed under the new standard. The Company’s implementation process is to review its patient account population to determine the appropriate distribution of patient accounts by payer (i.e., Medicare, patient pay, other third-party payer, etc.) into portfolios with similar collection experience that, when evaluated for collectability, will result in a materially consistent revenue amount for such portfolios as if each patient account were evaluated on a contract-by-contract basis.

The Company has not yet determined if it plans to utilize the full retrospective or modified retrospective method of adoption, but anticipates adopting the new standard in the first quarter of 2018.

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Stockholders' Equity (Tables)
9 Months Ended

Sep. 30, 2017

Stockholders' Equity [Abstract]

Allocation of Stock-Based Compensation Expense by Functional Area

Three Months Ended September 30,

Nine Months Ended September 30,

(in thousands)

2017

2016

2017

2016

Cost of revenue

$
21

$
24

$
61

$
70

Research and development

—

10

5

63

Sales and marketing

38

10

108

66

General and administrative

216

198

630

623

Total

$
275

$
242

$
804

$
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Organization, Basis Of Presentation And Significant Accounting And Reporting Policies (Details) - USD ($)
9 Months Ended

Aug. 31, 2017

Aug. 04, 2017

Feb. 17, 2017

Apr. 15, 2016

Sep. 30, 2017

Sep. 30, 2016

Dec. 31, 2016

Mar. 22, 2016

Organization Consolidation And Summary Of Significant Accounting Policies [Line Items]

Accumulated deficit $ (393,098,000) $ (385,556,000)

Proceeds from exercise of common stock warrants, net of issuance costs $ 3,577,000 3,577,000

Proceeds from issuance of private placement $ 3,577,000 $ 5,127,000 $ 5,127,000

Initial proceeds from loan $ 1,967,000

DECD [Member]

Organization Consolidation And Summary Of Significant Accounting Policies [Line Items]

Total borrowing amount $ 4,000,000

Initial proceeds from loan $ 2,000,000

Remaining loan amount $ 2,000,000

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Commitments And Contingencies (Details)
1 Months Ended 3 Months Ended 9 Months Ended

Apr. 15, 2016

USD ($)

Oct. 31, 2015

USD ($)

Apr. 30, 2015

USD ($)

item

Sep. 30, 2017

USD ($)

Sep. 30, 2016

USD ($)

Sep. 30, 2017

USD ($)

employee

Sep. 30, 2016

USD ($)

Dec. 31, 2016

USD ($)

Mar. 22, 2016

USD ($)

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Initial proceeds from loan $ 1,967,000

Operating leases rental expense $ 66,000 $ 71,000 $ 189,000 175,000

Net book value 1,364,000 $ 1,364,000 $ 1,911,000

Percent of royalty paid 4.00%

Minimum royalty payment $ 57,500

Royalty expense 30,000 24,000 94,000 66,000

Austin, Texas facility [Member]

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Annual base rent 85,000

Annual estimated common area charges, taxes and insurance $ 46,000

Lease expiration date Jan. 31, 2019

Trumbull, Connecticut Facility [Member]

Commitments And Contingencies [Line Items]

Annual base rent $ 32,000

Annual estimated common area charges, taxes and insurance 95,000

Leasehold improvements $ 596,000

Lease term 5 years

Rent abatement period 5 months

DECD [Member]

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Total borrowing amount $ 4,000,000

Fixed rate per annum 2.00%

Maturity date Apr. 15, 2026

Amount eligible for forgiveness $ 2,000,000

Job creation, number of employees | employee 40

Job creation, term 2 years

Debt, maturity term 10 years

Debt penalty 5.00%

Initial proceeds from loan $ 2,000,000

Remaining loan amount $ 2,000,000

Assets Under Capital Leases [Member]

Commitments And Contingencies [Line Items]

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Initial payment of laboratory equipment $ 125,000

Monthly payment for acquisition for equipment $ 3,500

Number of payments for purchase production of assets 36 months

Accumulated amortization 174,000 97,000 $ 174,000 97,000

Net book value $ 58,000 $ 135,000 $ 58,000 $ 135,000

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Stockholders' Equity (Narrative) (Details) - USD ($)
1 Months Ended 3 Months Ended 9 Months Ended

Aug. 31, 2017

Feb. 17, 2017

Dec. 31, 2014

Sep. 30, 2017

Sep. 30, 2017

Dec. 31, 2016

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Common stock, shares issued 3,796,818 3,747,125 59,998,748 59,998,748 52,328,492

Warrants issued in connection with private placement 4,166,659

Warrants exercised 3,796,818

Price per share $ 1.40 $ 0.001 $ 0.001 $ 0.001

Issued a warrant to purchase common stock with a cost $ 0.125

Proceeds from issuance of private placement $ 3,577,000 $ 5,127,000 $ 5,127,000

Incremental non-cash fair value of warrants $ 942,000 $ 942,000 942,000

Warrants outstanding to purchase shares 2,810,338

Exercise price of warrants $ 1.00 $ 1.80 $ 2.00

Fair value of warrants issued $ 804,000

Common stock value $ 4,296,000 $ 60,000 $ 60,000 $ 52,000

Gross proceeds from issuance of private placement $ 3,796,818

2010 Stock Incentive Plan [Member]

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Shares available for grant 8,122,983 8,122,983

2010 Stock Incentive Plan [Member] | Non-Employee Directors [Member] | Restricted Stock [Member]

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Restricted shares awarded 0 131,250

Fair value of restricted shares awarded $ 281,000

2010 Stock Incentive Plan [Member] | Non-Employee Directors [Member] | Restricted Stock [Member] | June 1, 2017 [Member]

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Vesting percentage 50.00%

2010 Stock Incentive Plan [Member] | Non-Employee Directors [Member] | Restricted Stock [Member] | September 1, 2017 [Member]

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Vesting percentage 25.00%

2010 Stock Incentive Plan [Member] | Non-Employee Directors [Member] | Restricted Stock [Member] | December 1, 2017 [Member]

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Vesting percentage 25.00%

2010 Stock Incentive Plan [Member] | Certain Consultants [Member] | Restricted Stock [Member]

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Restricted shares awarded 5,037

Fair value of restricted shares awarded $ 9,000

Restricted share units granted 27,878

Fair value of restricted share units $ 48,000

2010 Stock Incentive Plan [Member] | Certain Consultants [Member] | $2.14 [Member] | Stock Option [Member]

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Stock options granted 70,000

Stock options granted, average exercise price $ 2.14 $ 2.14

2010 Stock Incentive Plan [Member] | Certain Consultants [Member] | $1.32 [Member] | Stock Option [Member]

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Stock options granted 120,000

Stock options granted, average exercise price $ 1.32 $ 1.32

2010 Stock Incentive Plan [Member] | Certain Consultants [Member] | $1.32 [Member] | Stock Option [Member] | Share-based Compensation Award, Tranche One [Member]

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Vesting percentage 24.00%

2010 Stock Incentive Plan [Member] | Certain Officers And Employees [Member] | $2.14 [Member] | Stock Option [Member]

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Stock options granted 916,000

Stock options granted, average exercise price $ 2.14 $ 2.14

2010 Stock Incentive Plan [Member] | Certain Officers And Employees [Member] | $2.14 [Member] | Stock Option [Member] | Share-based Compensation Award, Tranche One [Member]

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Vesting percentage 25.00%

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Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2017	Oct. 31, 2017
Document And Entity Information [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Sep. 30, 2017
Document Fiscal Year Focus	2017
Document Fiscal Period Focus	Q3
Entity Registrant Name	VERMILLION, INC.
Entity Central Index Key	0000926617
Current Fiscal Year End Date	--12-31
Entity Filer Category	Smaller Reporting Company
Entity Common Stock, Shares Outstanding		59,998,748

Condensed Consolidated Balance Sheets - USD ($)	Sep. 30, 2017	Dec. 31, 2016
Current assets:
Cash and cash equivalents	$ 7,752,000	$ 5,242,000
Accounts receivable	221,000	275,000
Prepaid expenses and other current assets	175,000	498,000
Inventories	155,000	93,000
Total current assets	8,303,000	6,108,000
Property and equipment, net	1,364,000	1,911,000
Other assets	11,000
Total assets	9,678,000	8,019,000
Current liabilities:
Accounts payable	514,000	881,000
Accrued liabilities	1,430,000	1,464,000
Deferred revenue	62,000
Short-term debt	191,000	182,000
Other current liabilities	32,000	34,000
Total current liabilities	2,229,000	2,561,000
Non-current liabilities:
Long-term debt	1,528,000	1,667,000
Other non-current liabilities		29,000
Total liabilities	3,757,000	4,257,000
Commitments and contingencies (Note 3)
Stockholders' equity:
Common stock, par value $0.001 per share, 150,000,000 shares authorized at September 30, 2017 and December 31, 2016; 59,998,748 and 52,328,492 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively	60,000	52,000
Additional paid-in capital	398,959,000	389,266,000
Accumulated deficit	(393,098,000)	(385,556,000)
Total stockholders' equity	5,921,000	3,762,000
Total liabilities and stockholders' equity	$ 9,678,000	$ 8,019,000

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2017	Dec. 31, 2016
Condensed Consolidated Balance Sheets [Abstract]
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	150,000,000	150,000,000
Common stock, shares issued	59,998,748	52,328,492
Common stock, shares outstanding	59,998,748	52,328,492

Condensed Consolidated Statements Of Operations (Parenthetical) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016
Cost Of Revenue [Member]
Stock-based compensation expense	$ 29	$ 27	$ 108	$ 73
Research And Development [Member]
Stock-based compensation expense	2	10	7	63
Sales And Marketing [Member]
Stock-based compensation expense	38	14	115	70
General And Administrative [Member]
Stock-based compensation expense	$ 257	$ 210	$ 767	$ 655

Condensed Consolidated Statements Of Cash Flows - USD ($)	9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016
Cash flows from operating activities:
Net loss	$ (7,542,000)	$ (12,122,000)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	599,000	523,000
Stock-based compensation expense	997,000	861,000
Loss on sale and disposal of property and equipment	4,000	3,000
Changes in operating assets and liabilities:
Accounts receivable	54,000	(44,000)
Prepaid expenses and other assets	312,000	354,000
Inventories	(62,000)	(5,000)
Accounts payable, accrued liabilities and other liabilities	(401,000)	(769,000)
Deferred revenue	62,000
Net cash used in operating activities	(5,977,000)	(11,199,000)
Cash flows from investing activities:
Purchase of property and equipment	(56,000)	(1,240,000)
Net cash used in investing activities	(56,000)	(1,240,000)
Cash flows from financing activities:
Proceeds from private placement offering of common stock, net of issuance costs	5,127,000
Proceeds from exercise of common stock warrants, net of issuance costs	3,577,000
Proceeds from issuance of DECD loan, net of issuance costs		1,967,000
Principal repayment of DECD loan	(136,000)	(73,000)
Repayment of capital lease obligations	(25,000)	(22,000)
Proceeds from issuance of common stock from exercise of stock options		5,000
Net cash provided by financing activities	8,543,000	1,877,000
Net increase (decrease) in cash and cash equivalents	2,510,000	(10,562,000)
Cash and cash equivalents, beginning of year	5,242,000	18,642,000
Cash and cash equivalents, end of year	7,752,000	8,080,000
Supplemental disclosure of cash flow information:
Cash paid during the period for interest	36,000	$ 24,000
Supplemental disclosure of non-cash investing and financing activities:
Deemed dividend on warrant repricing	$ 942,000

Organization, Basis Of Presentation And Significant Accounting And Reporting Policies	9 Months Ended
	Sep. 30, 2017
Organization, Basis Of Presentation And Significant Accounting And Reporting Policies [Abstract]
Organization, Basis Of Presentation And Significant Accounting And Reporting Policies	1. ORGANIZATION, BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING AND REPORTING POLICIES Organization Vermillion, Inc. (“Vermillion”; Vermillion and its wholly-owned subsidiaries are collectively referred to as the “Company,” “we” or “our”) is incorporated in the state of Delaware, and is engaged in the business of developing and commercializing diagnostic tests for gynecologic disease. The Company sells OVA1™ and Overa™ risk of malignancy tests for ovarian cancer (“OVA1” and “Overa,” respectively) through Vermillion’s wholly-owned Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) certified clinical laboratory, ASPiRA LABS, Inc. (“ASPiRA LABS”). The Company also offers in-vitro diagnostic (“IVD”) trial services to third-party customers through its wholly-owned subsidiary, ASPiRA IVD, Inc. (“ASPiRA IVD”), which commenced operations in June 2016. ASPiRA IVD is a specialized, CLIA certified, laboratory provider dedicated to meeting the unique testing needs of IVD manufacturers seeking to commercialize high-complexity assays. Going Concern The Company has incurred significant net losses and negative cash flows from operations since inception, and as a result has an accumulated deficit of approximately $393,098,000 at September 30, 2017. The Company also expects to incur a net loss and negative cash flows from operations for the remainder of 2017 and the foreseeable future. The Company’s management believes that successful achievement of the Company’s business objectives will require additional financing. Given these conditions, there is substantial doubt about the Company’s ability to continue as a going concern. The condensed consolidated financial statements have been prepared on a going concern basis and do not include any adjustments that might result from these uncertainties. The Company expects to raise capital through a variety of sources, which may include the exercise of common stock warrants, equity offerings, debt financing, collaborations, licensing arrangements, grants and government funding and strategic alliances. However, additional funding may not be available when needed or on terms acceptable to the Company. If the Company is unable to obtain additional capital, it may not be able to continue sales and marketing, research and development, or other operations on the scope or scale of current activity and that could have a material adverse effect on the Company’s business, results of operations and financial condition. As discussed in Note 4, on August 31, 2017, certain investors exercised outstanding warrants for common stock for net proceeds of approximately $3,577,000 after deducting offering expenses. As discussed in Note 4, on February 17, 2017, the Company completed a private placement pursuant to which certain investors purchased Vermillion common stock and warrants to purchase shares of Vermillion common stock for net proceeds of approximately $5,127,000 after deducting offering expenses. As discussed in Note 3, in March 2016, the Company entered into an agreement (the “Loan Agreement”) pursuant to which it may borrow up to $4,000,000 from the State of Connecticut Department of Economic and Community Development (the “DECD”). An initial disbursement of $2,000,000 was made to the Company in April 2016 under the Loan Agreement. The Loan Agreement provides that the remaining $2,000,000 will be disbursed if and when the Company achieves certain future milestones. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8-03 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management of the Company, all adjustments, consisting of normal recurring adjustments necessary for the fair statement of results for the periods presented, have been included. The results of operations of any interim period are not necessarily indicative of the results of operations for the full year or any other interim period. The unaudited condensed consolidated financial statements and related disclosures have been prepared with the presumption that users of the interim unaudited condensed consolidated financial statements have read or have access to the audited consolidated financial statements for the preceding fiscal year. The condensed consolidated balance sheet at December 31, 2016 included in this report has been derived from the audited consolidated financial statements at that date but does not include all the information and footnotes required by GAAP. Accordingly, these unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2016 included in Vermillion’s Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on March 31, 2017 (the “2016 Annual Report”). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimated results. Significant Accounting and Reporting Policies Revenue Recognition Product Revenue The Company has adopted ASC 954-605, Health Care Entities—Revenue Recognition, as revenue from laboratory services has become significant to the Company. The Company's product revenue is generated by performing diagnostic services using its OVA1 and Overa tests, and the service is completed upon the delivery of test results to the prescribing physician. The Company recognizes revenue related to billings for Medicare and commercial payers on an accrual basis, net of contractual and other adjustments, when amounts that will ultimately be realized can be estimated. Until a contract has been negotiated with a commercial payer or governmental program, the OVA1 and Overa tests may or may not be covered by these entities' existing reimbursement policies. In addition, patients do not enter into direct agreements with the Company that commit them to pay any portion of the cost of the tests in the event that their insurance declines to reimburse the Company. In the absence of an agreement with the patient or other clearly enforceable legal right to demand payment from the patient, the related revenue is only recognized upon cash receipt. Estimates of amounts that the Company will ultimately realize require significant judgment by management. Some patients have out-of-pocket costs for amounts not covered by their insurance carrier, and the Company may bill the patient directly for these amounts in the form of co-payments and co-insurance in accordance with the patient’s health plan. Some payers may not cover the OVA1 and Overa tests as ordered by the prescribing physician under their reimbursement policies. The Company pursues reimbursement from such patients on a case-by-case basis. In the absence of contracted reimbursement coverage or the ability to estimate the amount that will ultimately be realized for the Company's services, revenue is recognized when cash is received. See discussion of ASU No. 2014-09 (defined below) included in Recent Accounting Pronouncements below. Service Revenue The Company’s service revenue is generated by performing IVD trial services for third-party customers. In accordance with SAB Topic 13, service revenue is recognized when the following revenue recognition criteria are met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the fee is fixed or determinable; and (4) collectability is reasonably assured. See discussion of ASU No. 2014-09 included in Recent Accounting Pronouncements below. The Company has made no other significant changes in its critical accounting policies and estimates from those disclosed in the 2016 Annual Report. Recent Accounting Pronouncements In March 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting (Topic 718), Compensation - Stock Compensation (“ASU 2016-09”). The new guidance simplifies several aspects of the accounting for share-based payments, including immediate recognition of all excess tax benefits and deficiencies in the income statement, changing the threshold to qualify for equity classification up to the employees' maximum statutory tax rates, allowing an entity-wide accounting policy election to either estimate the number of awards that are expected to vest or account for forfeitures as they occur, and clarifying the classification on the statement of cash flows for the excess tax benefit and employee taxes paid when an employer withholds shares for tax-withholding purposes. ASU 2016-09 is effective for annual reporting periods beginning after December 15, 2016 and interim periods within that reporting period. The adoption of this standard is not expected to have a material effect on our financial statements. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”), which removes inconsistencies and weaknesses in revenue requirements, provides a more robust framework for addressing revenue issues, improves comparability of revenue recognition practices across entities, industries, jurisdictions and capital markets, provides more useful information to users of financial statements through improved disclosure requirements and simplifies the preparation of financial statements by reducing the number of requirements to which an entity must refer. This guidance requires that an entity depict the consideration by applying a five-step analysis in determining when and how revenue is recognized. The new model will require revenue recognition to depict the transfer of promised goods or services to customers in an amount that reflects the consideration a company expects to receive in exchange for those goods or services. On April 1, 2015, the FASB voted for a one-year deferral of the effective date of the new revenue recognition standard, ASU No. 2014-09. On July 15, 2015, the FASB affirmed these changes, which requires public entities to apply the amendments in ASU 2014-09 for annual reporting beginning after December 15, 2017. Early adoption is permitted beginning after December 31, 2016, the original effective date in ASU 2014-09. The Company is in the early stages of its analysis of the effect ASU 2014-09 will have on its Service Revenue, but expects to complete its analysis during the fourth quarter of 2017. The Company is also continuing its analysis of the effect ASU 2014-09 will have on its Product Revenue and also expects to complete this analysis in the fourth quarter of 2017. Revenue that is recognized upon the ultimate receipt of cash under the Company’s existing revenue recognition policy will have to be reassessed under the new standard. The Company’s implementation process is to review its patient account population to determine the appropriate distribution of patient accounts by payer (i.e., Medicare, patient pay, other third-party payer, etc.) into portfolios with similar collection experience that, when evaluated for collectability, will result in a materially consistent revenue amount for such portfolios as if each patient account were evaluated on a contract-by-contract basis. The Company has not yet determined if it plans to utilize the full retrospective or modified retrospective method of adoption, but anticipates adopting the new standard in the first quarter of 2018.

Agreements With Quest Diagnostics Incorporated	9 Months Ended
Agreements With Quest Diagnostics Incorporated	Sep. 30, 2017
Agreements With Quest Diagnostics Incorporated [Abstract]
Agreements With Quest Diagnostics Incorporated	2. AGREEMENTS WITH QUEST DIAGNOSTICS INCORPORATED In March 2015, the Company entered into a commercial agreement with Quest Diagnostics, Incorporated (“Quest Diagnostics”). Pursuant to this agreement, all OVA1 U.S. testing services for Quest Diagnostics customers were transferred to Vermillion’s wholly-owned subsidiary, ASPiRA LABS, as of August 2015. Pursuant to this agreement, as amended as of March 11, 2017, Quest Diagnostics has agreed to provide blood draw and logistics support by transporting specimens from its clients to ASPiRA LABS for testing through at least March 11, 2018 in exchange for a market value fee. Per the terms of this agreement, the Company will not offer to existing or future Quest Diagnostics customers tests that Quest Diagnostics offers.

Commitments And Contingencies	9 Months Ended
Commitments And Contingencies	Sep. 30, 2017
Commitments And Contingencies [Abstract]
Commitments And Contingencies	3. COMMITMENTS AND CONTINGENCIES Development Loan On March 22, 2016, the Company entered into the Loan Agreement, pursuant to which the Company may borrow up to $4,000,000 from the DECD. Proceeds from the $2,000,000 April 2016 initial disbursement under the Loan Agreement were utilized primarily to fund the build-out, information technology infrastructure and other costs related to the Company’s Trumbull, Connecticut facility and operations. The loan bears interest at a fixed rate of 2.0% per annum and requires equal monthly payments of principal and interest until maturity, which occurs on April 15, 2026. As security for the loan, the Company has granted the DECD a blanket security interest in the Company’s personal and intellectual property. The DECD’s security interest in the Company’s intellectual property may be subordinated to a qualified institutional lender. Under the terms of the Loan Agreement, the Company may be eligible for forgiveness of up to $2,000,000 of the principal amount of the loan if the Company achieves certain job creation and retention milestones by March 1, 2018. Conversely, if the Company is unable to meet these job creation milestones, namely, hiring 40 full-time employees with a specified average annual salary within the allotted timeframe and retaining those employees for a two-year period or does not maintain the Company’s Connecticut operations for a period of 10 years, the DECD may require early repayment of a portion or all of the loan plus a penalty of 5%. As discussed above, an initial disbursement of $2,000,000 was made to the Company on April 15, 2016 under the Loan Agreement. The Loan Agreement provides that the remaining $2,000,000 will be disbursed if and when the Company achieves certain future milestones. The loan may be prepaid at any time without premium or penalty . Operating Leases The Company leases facilities to support its business of discovering, developing and commercializing diagnostic tests in the fields of gynecologic disease. The Company’s principal facility, including the CLIA laboratory used by ASPiRA LABS, is located in Austin, Texas, and the CLIA laboratory used by ASPiRA IVD is located in Trumbull, Connecticut. The Austin, Texas lease includes an aggregate annual base rent of $85,000 and annual estimated common area charges, taxes and insurance of $46,000 and expires on January 31, 2019. In October 2015, the Company entered into a lease agreement for a facility in Trumbull, Connecticut. The lease required initial payments for the buildout of leasehold improvements to the office space, which were approximately $596,000. The term of the lease is five years beginning after the initial date of occupancy in January 2016 and a rent abatement period of five months. The lease includes an aggregate annual base rent of $32,000 and annual estimated common area charges, taxes and insurance of $95,000. Building rent for the three months ended September 30, 2017 and 2016 totaled $66,000 and $71,000, respectively. Building rent for the nine months ended September 30, 2017 and 2016 totaled $189,000 and $175,000, respectively. Capital Lease In April 2015, the Company leased a laboratory instrument for a total initial payment of $125,000 and ongoing payments of approximately $3,500 per month for 36 months after delivery. The agreement also requires minimum annual purchases of reagents from the manufacturer of the equipment. The laboratory instrument was placed into service on July 1, 2015. The accumulated amortization of assets under capital lease obligations was $174,000 and $97,000 as of September 30, 2017 and 2016, respectively. The net book value of assets under capital lease obligations was $58,000 and $135,000 as of September 30, 2017 and 2016, respectively. Non-cancelable Royalty Obligations The Company is a party to an amended research collaboration agreement with The Johns Hopkins University School of Medicine under which the Company licenses certain of its intellectual property. Under the terms of the amended research collaboration agreement, Vermillion is required to pay the greater of 4% royalties on net sales of diagnostic tests using the assigned patents or annual minimum royalties of $57,500. Royalty expense for the three months ended September 30, 2017 and 2016 totalled $30,000 and $24,000, respectively. Royalty expense for the nine months ended September 30, 2017 and 2016 totalled $94,000 and $66,000, respectively.

Loss Per Share	9 Months Ended
Loss Per Share	Sep. 30, 2017
Loss Per Share [Abstract]
Loss Per Share	5. LOSS PER SHARE The Company calculates basic loss per share using the weighted average number of shares of Vermillion common stock outstanding during the period. Because the Company is in a net loss position, diluted loss per share is calculated using the weighted average number of shares of Vermillion common stock outstanding and excludes the effects of 7,971,860 and 7,485,632 potential shares of Vermillion common stock as of September 30, 2017 and 2016, respectively, that are anti-dilutive. Potential shares of Vermillion common stock include incremental shares of Vermillion common stock issuable upon the exercise of outstanding warrants, stock options and unvested restricted stock units.

Organization, Basis Of Presentation And Significant Accounting And Reporting Policies (Details) - USD ($)					9 Months Ended
	Aug. 31, 2017	Aug. 04, 2017	Feb. 17, 2017	Apr. 15, 2016	Sep. 30, 2017	Sep. 30, 2016	Dec. 31, 2016	Mar. 22, 2016
Organization Consolidation And Summary Of Significant Accounting Policies [Line Items]
Accumulated deficit					$ (393,098,000)		$ (385,556,000)
Proceeds from exercise of common stock warrants, net of issuance costs		$ 3,577,000			3,577,000
Proceeds from issuance of private placement	$ 3,577,000		$ 5,127,000		$ 5,127,000
Initial proceeds from loan						$ 1,967,000
DECD [Member]
Organization Consolidation And Summary Of Significant Accounting Policies [Line Items]
Total borrowing amount								$ 4,000,000
Initial proceeds from loan				$ 2,000,000
Remaining loan amount								$ 2,000,000

Commitments And Contingencies (Details)		1 Months Ended		3 Months Ended		9 Months Ended
Commitments And Contingencies (Details)	Apr. 15, 2016 USD ($)	Oct. 31, 2015 USD ($)	Apr. 30, 2015 USD ($) item	Sep. 30, 2017 USD ($)	Sep. 30, 2016 USD ($)	Sep. 30, 2017 USD ($) employee	Sep. 30, 2016 USD ($)	Dec. 31, 2016 USD ($)	Mar. 22, 2016 USD ($)
Commitments And Contingencies [Line Items]
Initial proceeds from loan							$ 1,967,000
Operating leases rental expense				$ 66,000	$ 71,000	$ 189,000	175,000
Net book value				1,364,000		$ 1,364,000		$ 1,911,000
Percent of royalty paid						4.00%
Minimum royalty payment						$ 57,500
Royalty expense				30,000	24,000	94,000	66,000
Austin, Texas facility [Member]
Commitments And Contingencies [Line Items]
Annual base rent						85,000
Annual estimated common area charges, taxes and insurance						$ 46,000
Lease expiration date						Jan. 31, 2019
Trumbull, Connecticut Facility [Member]
Commitments And Contingencies [Line Items]
Annual base rent		$ 32,000
Annual estimated common area charges, taxes and insurance		95,000
Leasehold improvements		$ 596,000
Lease term						5 years
Rent abatement period						5 months
DECD [Member]
Commitments And Contingencies [Line Items]
Total borrowing amount									$ 4,000,000
Fixed rate per annum									2.00%
Maturity date						Apr. 15, 2026
Amount eligible for forgiveness									$ 2,000,000
Job creation, number of employees \| employee						40
Job creation, term						2 years
Debt, maturity term						10 years
Debt penalty						5.00%
Initial proceeds from loan	$ 2,000,000
Remaining loan amount									$ 2,000,000
Assets Under Capital Leases [Member]
Commitments And Contingencies [Line Items]
Number of purchased laboratory instruments \| item			1
Initial payment of laboratory equipment			$ 125,000
Monthly payment for acquisition for equipment			$ 3,500
Number of payments for purchase production of assets						36 months
Accumulated amortization				174,000	97,000	$ 174,000	97,000
Net book value				$ 58,000	$ 135,000	$ 58,000	$ 135,000

Stockholders' Equity (Narrative) (Details) - USD ($)			1 Months Ended	3 Months Ended	9 Months Ended
Stockholders' Equity (Narrative) (Details) - USD ($)	Aug. 31, 2017	Feb. 17, 2017	Dec. 31, 2014	Sep. 30, 2017	Sep. 30, 2017	Dec. 31, 2016
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock, shares issued	3,796,818	3,747,125		59,998,748	59,998,748	52,328,492
Warrants issued in connection with private placement			4,166,659
Warrants exercised	3,796,818
Price per share		$ 1.40		$ 0.001	$ 0.001	$ 0.001
Issued a warrant to purchase common stock with a cost		$ 0.125
Proceeds from issuance of private placement	$ 3,577,000	$ 5,127,000			$ 5,127,000
Incremental non-cash fair value of warrants	$ 942,000			$ 942,000	942,000
Warrants outstanding to purchase shares		2,810,338
Exercise price of warrants	$ 1.00	$ 1.80	$ 2.00
Fair value of warrants issued		$ 804,000
Common stock value		$ 4,296,000		$ 60,000	$ 60,000	$ 52,000
Gross proceeds from issuance of private placement	$ 3,796,818
2010 Stock Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Shares available for grant				8,122,983	8,122,983
2010 Stock Incentive Plan [Member] \| Non-Employee Directors [Member] \| Restricted Stock [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Restricted shares awarded				0	131,250
Fair value of restricted shares awarded					$ 281,000
2010 Stock Incentive Plan [Member] \| Non-Employee Directors [Member] \| Restricted Stock [Member] \| June 1, 2017 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting percentage					50.00%
2010 Stock Incentive Plan [Member] \| Non-Employee Directors [Member] \| Restricted Stock [Member] \| September 1, 2017 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting percentage					25.00%
2010 Stock Incentive Plan [Member] \| Non-Employee Directors [Member] \| Restricted Stock [Member] \| December 1, 2017 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting percentage					25.00%
2010 Stock Incentive Plan [Member] \| Certain Consultants [Member] \| Restricted Stock [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Restricted shares awarded				5,037
Fair value of restricted shares awarded				$ 9,000
Restricted share units granted					27,878
Fair value of restricted share units					$ 48,000
2010 Stock Incentive Plan [Member] \| Certain Consultants [Member] \| $2.14 [Member] \| Stock Option [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock options granted					70,000
Stock options granted, average exercise price				$ 2.14	$ 2.14
2010 Stock Incentive Plan [Member] \| Certain Consultants [Member] \| $1.32 [Member] \| Stock Option [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock options granted				120,000
Stock options granted, average exercise price				$ 1.32	$ 1.32
2010 Stock Incentive Plan [Member] \| Certain Consultants [Member] \| $1.32 [Member] \| Stock Option [Member] \| Share-based Compensation Award, Tranche One [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting percentage				24.00%
2010 Stock Incentive Plan [Member] \| Certain Officers And Employees [Member] \| $2.14 [Member] \| Stock Option [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock options granted					916,000
Stock options granted, average exercise price				$ 2.14	$ 2.14
2010 Stock Incentive Plan [Member] \| Certain Officers And Employees [Member] \| $2.14 [Member] \| Stock Option [Member] \| Share-based Compensation Award, Tranche One [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting percentage					25.00%
2010 Stock Incentive Plan [Member] \| Certain Officers And Employees [Member] \| $2.14 [Member] \| Stock Option [Member] \| Share-based Compensation Award, Tranche One [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting percentage					25.00%
2010 Stock Incentive Plan [Member] \| Certain Officers And Employees [Member] \| $2.14 [Member] \| Performance Shares [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock options granted					250,000
Stock options granted, average exercise price				$ 2.14	$ 2.14
2010 Stock Incentive Plan [Member] \| Certain Officers And Employees [Member] \| $1.32 [Member] \| Stock Option [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock options granted				22,500
Stock options granted, average exercise price				$ 1.32	$ 1.32
2010 Stock Incentive Plan [Member] \| Certain Officers And Employees [Member] \| $1.32 [Member] \| Stock Option [Member] \| Share-based Compensation Award, Tranche One [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting percentage				25.00%
2010 Stock Incentive Plan [Member] \| Certain Officers And Employees [Member] \| $1.83 [Member] \| Stock Option [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock options granted					14,500
Stock options granted, average exercise price				$ 1.83	$ 1.83
2010 Stock Incentive Plan [Member] \| Certain Officers And Employees [Member] \| $1.83 [Member] \| Stock Option [Member] \| Share-based Compensation Award, Tranche One [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting percentage					25.00%

Loss Per Share (Details) - shares	9 Months Ended
Loss Per Share (Details) - shares	Sep. 30, 2017	Sep. 30, 2016
Loss Per Share [Abstract]
Antidilutive securities excluded from computation of earnings per share	7,971,860	7,485,632