AUSTIN, Texas, Aug. 08, 2019 (GLOBE NEWSWIRE) -- Vermillion, Inc. (Nasdaq: VRML), a bio-analytical based women’s health company focused on gynecologic disease, today reported its financial results for the second quarter ended June 30, 2019.

“We are very pleased by the continued positive momentum for OVA1Plus.  The growth in product volume and revenue are a reflection of their efficacy compared to the current standard of care in ovarian cancer risk management,” stated Valerie Palmieri, President and CEO of Vermillion. “We continue to focus on maximizing commercialization efforts and payer penetration to become the one and only choice for pelvic mass risk management.”

Recent Corporate Highlights 

Year over Year Results - Second Quarter 2019 versus Second Quarter 2018:

Year over Year Results - First Half 2019 versus First Half 2018

New Health Plan Contracts
Expanded preferred coverage of OVA1 ovarian cancer risk assessment test with the addition of two new health plan in network contract agreements.  BlueCross BlueShield of Texas and Blue Cross Blue Shield of Arizona will now provide in network coverage to nearly 6 million additional lives.

Clinical Study Publications
June 2019- Announced the acceptance and recent publication of the first of several studies demonstrating that OVA1 (Multivariate Index Assay, MIA) improves ovarian cancer detection in African American women.
Biomarkers in Cancer Publication - A study of 1029 patients; 853 Caucasian with 250 malignancies, and 153 African American with 24 malignancies. The study demonstrated that OVA1 demonstrated a sensitivity of 79.1%, compared to 54.5% with HE4 + CA125 (ROMA). Demonstrating a 45% improvement in sensitivity.

July 2019- Advances in Therapy Publication - A study of 993 patients, comparing Overa™, Vermillion’s 2nd Generation multivariate index assay, vs ROMA vs CA125.  Overa™ had the highest performance in early stage ovarian cancer risk detection with 90.5 % sensitivity compared to ROMA at 76.2% sensitivity and CA125 at 63.1% sensitivity, based on ACOG guidance cutoff of 200 U/ml.

July 2019- Journal of Surgical Oncology- Accepted for publication. A study of 878 patients comparing current standard of care imaging tools (ultrasound and CT scan) compared to Overa™ and its ability to vastly improve the ovarian cancer risk assessment care pathway, when used in clinical workup for adnexal masses. 

July 2019- Abstract acceptance of our poster, Ovarian Malignancy Risk Stratification Using a Third-Generation Multivariate Index Assay, at the European Society of Gynecologic Oncology to be presented in November 2019.

Financials:

Conference Call and Webcast
Vermillion’s President and CEO, Valerie Palmieri, will host a call today at 4:30 p.m. Eastern Daylight Time to discuss results followed by a question and answer period.

Thursday, August 8th @ 4:30pm Eastern Time
855-327-6837 - Domestic Investors
631-891-4304 - International Investors Dial
10007441 - Conference ID

About Vermillion, Inc.
Vermillion, Inc. is dedicated to the discovery, development and commercialization of novel high-value diagnostic and bio-analytical solutions that help physicians diagnose, treat and improve gynecologic health outcomes for women. Vermillion, along with its prestigious scientific collaborators, discovers, develops, and delivers innovative diagnostic and technology tools that help women with serious diseases.  The company’s initial in vitro diagnostic test, OVA1® (MIA), was the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, and represented a new class of software-based liquid biopsy in vitro diagnostics. In March 2016, Vermillion received FDA clearance for Overa™, a Multivariate Index Assay 2nd Generation (MIA2G) test with significantly improved specificity and ease of use. For additional information, including published clinical trials, visit www.vermillion.com.

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 revenue, test volumes and gross profits. 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. 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
Arr@LifeSciAdvisors.com

Media Contact:
Srijan Sen
RXMD
Tel 212-537-9495
ssen@rxmedyn.com


Vermillion, Inc.
Consolidated Balance Sheets
(Amounts in Thousands, Except Share and Par Value Amounts)
(Unaudited)

      
      
 June 30, December 31,
 2019
 2018 
Assets     
Current assets:     
Cash and cash equivalents$16,179  $9,360 
Accounts receivable, net 800   786 
Prepaid expenses and other current assets 496   550 
Inventories 90   92 
Total current assets 17,565   10,788 
Property and equipment, net 472   608 
Other assets 115   12 
Total assets$18,152  $11,408 
      
Liabilities and Stockholders’ Equity     
Current liabilities:     
Accounts payable$811  $950 
Accrued liabilities 2,473   1,825 
Short-term debt 191   189 
Other current liabilities 86   - 
Total current liabilities 3,561   2,964 
Non-current liabilities:     
Long-term debt 1,196   1,292 
Other non-current liabilities 29   - 
Total liabilities 4,786   4,256 
Commitments and contingencies     
Stockholders’ equity:     
Preferred stock, $0.001 par value, 5,000,000 shares authorized, none issued and outstanding at June 30, 2019 and December 31, 2018 -   - 
Common stock, par value $0.001 per share, 150,000,000 shares authorized at June 30, 2019 and December 31, 2018; 94,378,200 and 75,501,394 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively 94   75 
Additional paid-in capital 428,226   414,001 
Accumulated deficit (414,954)  (406,924)
Total stockholders’ equity 13,366   7,152 
Total liabilities and stockholders’ equity$18,152  $11,408 


Vermillion, Inc.
Consolidated Statements of Operations
(Amounts in Thousands, Except Share and Per Share Amounts)
(Unaudited)

            
            
 Three Months Ended June 30,  Six Months Ended June 30,
 2019  2018  2019  2018 
Revenue:           
Product$1,100  $627  $1,879  $1,240 
Service 42   81   66   117 
Total revenue 1,142   708   1,945   1,357 
Cost of revenue:(1)           
Product 698   528   1,214   1,061 
Service 210   280   388   550 
Total cost of revenue 908   808   1,602   1,611 
Gross profit (loss) 234   (100)  343   (254)
Operating expenses:           
Research and development(2) 225   154   434   296 
Sales and marketing(3) 2,780   1,478   5,144   2,703 
General and administrative(4) 1,534   1,299   2,789   2,613 
Total operating expenses 4,539   2,931   8,367   5,612 
Loss from operations (4,305)  (3,031)  (8,024)  (5,866)
Interest income (expense), net (2)  (7)  5   (19)
Other income (expense), net (7)  (11)  (11)  (14)
Net loss$(4,314) $(3,049) $(8,030) $(5,899)
Net loss per share - basic and diluted$(0.06) $(0.04) $(0.11) $(0.09)
Weighted average common shares used to compute basic and diluted net loss per common share 76,205,894   69,353,622   75,860,411   64,721,128 
Non-cash stock-based compensation expense included in cost of revenue and operating expenses:           
(1)  Cost of revenue$21  $28  $37  $58 
(2)  Research and development 2   1   4   2 
(3)  Sales and marketing 39   28   61   71 
(4)  General and administrative 351   304   495   412