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AUSTIN, Texas, March 28, 2019 (GLOBE NEWSWIRE) -- Vermillion, Inc. (NASDAQ: VRML), a bioanalytical-based women’s health company focused on gynecologic disease, today reported its financial results for the fourth quarter and year ended December 31, 2018.
“We are very pleased by the reception of our new generation of technology, OVA1+, since its launch in Q4. This offering has cured the gap of the first generation of technology launched in 2010,” stated Valerie Palmieri, President and CEO of Vermillion. “The feedback from providers and patients has been tremendous, and we believe that our risk assessment offerings have the potential to change the paradigm in ovarian cancer risk management.
“2019 will be a transformative year for Vermillion as we continue to roll-out our new generation of technology, new platform, CA125 ethnic disparity gap awareness, and full commercial strategy. We have strategically expanded our commercialization team and the number of lives under coverage with two national carriers. We believe we are well positioned to continue build on the positive momentum and it is time that all women of every socioeconomic background receive the best care possible and we are proud and excited to make that happen.”
Recent Corporate Developments Highlights
Fourth Quarter Financial Highlights
Year-End 2018 Financial Highlights
Conference Call and Webcast
Vermillion’s President and CEO, Valerie Palmieri, will host a call today to discuss results followed by a question and answer period at 4:30 p.m. Eastern Time.
Thursday, March 28th @ 4:30pm Eastern Time
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.
This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. 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 September 30, 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
Consolidated Balance Sheets
(Amounts in Thousands, Except Share and Par Value Amounts)
|Cash and cash equivalents||$||9,360||$||5,539|
|Prepaid expenses and other current assets||550||459|
|Total current assets||10,788||6,305|
|Property and equipment, net||608||1,181|
|Liabilities and Stockholders’ Equity|
|Other current liabilities||-||29|
|Total current liabilities||2,964||2,609|
|Other non-current liabilities||-||-|
|Commitments and contingencies|
|Preferred stock, $0.001 par value, 5,000,000 shares authorized, none issued and outstanding at December 31, 2018 and 2017||-||-|
|Common stock, $0.001 par value, 150,000,000 shares authorized; 75,501,394 and 60,036,017 shares issued and outstanding at December 31, 2018 and 2017, respectively||75||60|
|Additional paid-in capital||414,001||399,400|
|Total stockholders’ equity||7,152||3,407|
|Total liabilities and stockholders’ equity||$||11,408||$||7,497|
Consolidated Statements of Operations
(Amounts in Thousands, Except Share and Per Share Amounts)
|Three Months Ended December 31,||Year Ended December 31,|
|Cost of revenue:(1)|
|Total cost of revenue||753||714||3,142||2,914|
|Gross profit (loss)||169||84||(89||)||207|
|Research and development(2)||125||152||550||837|
|Sales and marketing(3)||1,596||1,154||5,642||4,268|
|General and administrative(4)||1,272||1,718||5,052||5,543|
|Total operating expenses||2,993||3,024||11,244||10,648|
|Loss from operations||(2,824||)||(2,940||)||(11,333||)||(10,441||)|
|Interest income (expense), net||3||(10||)||(22||)||(42||)|
|Other income (expense), net||1||(7||)||(16||)||(14||)|
|Loss before income taxes||(2,820||)||(2,957||)||(11,371||)||(10,497||)|
|Deemed dividend on warrant repricing||-||-||-||(942||)|
|Net loss attributable to common stockholders||$||(2,820||)||$||(2,957||)||$||(11,371||)||$||(11,439||)|
|Net loss per share attributable to common stockholders - basic and diluted||$||(0.04||)||$||(0.05||)||$||(0.16||)||$||(0.20||)|
|Weighted average common shares used to compute basic and diluted net loss per common share||75,420,104||60,011,306||70,085,842||56,943,596|
|Non-cash stock-based compensation expense included in expenses:|
|(1) Cost of revenue||$||31||$||28||$||124||$||136|
|(2) Research and development||2||2||6||9|
|(3) Sales and marketing||17||45||102||160|
|(4) General and administrative||212||367||869||1,134|