UNITED STATES

SECURITIES AND EXCHANGE COMMISSION 

Washington, D.C. 20549

   

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Form 8-K

   

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CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 26, 2020

   

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Vermillion, Inc.

(Exact name of registrant as specified in its charter)

   

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Registrant’s telephone number, including area code:  (512) 519-0400

   

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

   









Securities registered pursuant to Section 12(b) of the Act:





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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).



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.  ☐



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Item 2.02Results of Operations and Financial Condition.

On March 26, 2020, Vermillion, Inc. (the “Company”) issued a press release reporting financial results for the three and twelve months ended December 31, 2019.  A copy of the Company’s press release is attached hereto as Exhibit 99.1.

The information provided in this Current Report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section.  Such information shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any incorporation by reference language in such filing.



Item 9.01Financial Statements and Exhibits. 



 (d)         Exhibits











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SIGNATURE

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 hereunto duly authorized.



























































































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Vermillion Reports Fourth Quarter 2019 Financial Results



March 26, 2020



Conference Call scheduled for today, March 26th at 4:30 p.m. ET



AUSTIN, Texas — March 26, 2020 — Vermillion, Inc. (Nasdaq: VRML), a bio-analytical based women’s health company focused on gynecologic disease, today reported its financial results for the fourth quarter and year ended December 31, 2019.



“We are very pleased with the overall business momentum we created in 2019 and the continued growth into 2020. We have also implemented strategies to help manage the impact on our business of the COVID-19 pandemic and actions taken to contain it,” stated Valerie Palmieri, President and CEO of Vermillion. “Our team is focused on emerging from COVID-19 even stronger, with an increase in the use of virtual sales tools, as well as a deep product pipeline to address the entire patient life cycle, from endometriosis to ovarian cancer risk management. We remain committed to capitalizing on one of the fastest growing sectors today, women’s health.”



Recent Corporate Highlights 



Year over Year Results – Fourth Quarter 2019 versus Fourth Quarter 2018:



Year over Year Results – Twelve Months of 2019 versus Twelve Months of 2018:



Cigna Contract

-We have executed a preferred in-network contract agreement with CIGNA. This in-network agreement adds another 16M lives to our contracted plans, and includes not only OVA1, but also Overa and our ovarian and carrier genetics testing panels. We are pleased with the final agreed prices, which will be effective April 1, 2020.

Medicaid Coverage

-We have made considerable advancements in our state Medicaid coverage. We have added a total of 9 state Medicaid plans to our positive coverage list. Having this coverage in place is

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critical to managing underserved populations, as we believe OVA1 is the only technology available today that has adequate sensitivity for early stage Ovarian cancer detection in African American women.



State of Connecticut Financing

We recently concluded an amendment to our agreement with the State of Connecticut Department of Economic Community Development. We previously announced a $4M loan from Connecticut, $2M of which we received in 2016. We are eligible for the additional $2M based on target revenue and, as of this new amendment, a revised target employment milestone.  We expect to achieve the revised target employment levels in 2020. 



Fourth Quarter Financial Highlights:



















Conference Call and Webcast

Vermillion, Inc. will host a call today at 4:30 p.m. Eastern Daylight Time to discuss results followed by a question and answer period.

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Thursday, March 26th @ 4:30pmET



About Vermillion, Inc.

Vermillion, Inc. is transforming women’s health with the discovery, development and commercialization of innovative testing options and bio-analytical solutions that help physicians assess risk, optimize patient management and improve gynecologic health outcomes for women. OVA1®plus combines our FDA-cleared products OVA1® and OVERA® to detect risk of ovarian malignancy in women with adnexal masses. ASPiRA GenetiXSM testing offers both targeted and comprehensive genetic testing options with a gynecologic focus.  With over 10 years of expertise in ovarian cancer risk assessment Vermillion has expertise in cutting-edge research to inform our next generation of products. Our focus is on delivering products that allow healthcare providers to stratify risk, facilitate early detection and optimize treatment plans.

Visit our website for more information about our products at www.vermillion.com.



Forward-Looking Statements

This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995 including statements regarding expected timing and receipt of proceeds from the State of Connecticut Department of Economic Development loan. These statements involve a number of risks and uncertainties.  All statements other than statements of historical facts contained in this press release are forward-looking statements. Words such as “may,” “expects,” “intends,” “anticipates,” “believes,” “estimates,” “plans,” “seeks,” “could,” “should,” “continue,” “will,” “potential,” “projects” and similar expressions are intended to identify forward-looking statements.  These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including the risks and uncertainties inherent in Vermillion’s business, including those described in the section entitled “Risk Factors” in Vermillion’s Annual Report on Form 10-K for the year ended December 31, 2018, as supplemented by the section entitled “Risk Factors” in Vermillion’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2019. The events and circumstances reflected in Vermillion’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements.  Vermillion expressly disclaims any obligation to update, amend or clarify any forward-looking statements to reflect events, new information or circumstances occurring after the date of this press release, except as required by law.





Investor Relations Contact:

Ashley R. Robinson

LifeSci Advisors, LLC

Tel 617-535-7742

[email protected]m



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Vermillion

Q4 2019 Earnings Highlights

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This presentation contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. 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 of this presentation,  and the Company does not assume any obligation to update, amend or clarify them to reflect events, new  information or circumstances after such date except as required by law. Company estimates set forth in this presentation are based on various sources of information and various assumptions and judgments made by the Company, which Company management believes are reasonable. However, the Company cannot assure you that Company estimates are correct, and actual results may materially differ from Company estimates.

The forward-looking statements reflect the views of the Company as of the date of this presentation and are  subject to certain risks, uncertainties and assumptions, including those described in the section entitled “Risk  Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 and quarterly  report on Form 10-Q for the quarter ended September 30, 2019.

This presentation is © copyright 2020 by Vermillion, Inc. All Rights Reserved.



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Vermillion, Inc. Innovation Pipeline

All release dates based on management estimates

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Patient Lifecycle with OVA Technology – solving diagnostic dilemmas from puberty to cure

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OVA1 Weekly Volumes

Weekly Volume 2019

Note: While we did continue to hit an annualized run rate of 16 to 17k, it was slightly less than we forecasted as the holiday calendar impacted patient visits. We believe many patients took an entire week off and did not schedule doctor appointments.



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Vermillion

Our Mission

Enable Early Ovarian Cancer Detection for All Ages and Ethnicities

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