Vermillion Reports First Quarter 2014 Results

                Vermillion Reports First Quarter 2014 Results  PR Newswire  AUSTIN, Texas, May 15, 2014  AUSTIN, Texas, May 15, 2014 /PRNewswire/ -- Vermillion, Inc. (NASDAQ: VRML), a multivariate diagnostics company focused on gynecologic cancers and women's health, reported on its results for the quarter ended March 31, 2014.  Q1 2014 Key Developments    oFormed ASPiRA LABS, Inc., a clinical laboratory which will specialize in     applying biomarker-based technologies that address critical needs in the     management of gynecologic cancers. ASPiRA LABS will provide diagnostic     processing and results using a state-of-the-art biomarker-based diagnostic     algorithm that aids in clinical decision making and advances personalized     treatment plans.   oSubstantially increased U.S. field sales presence in order to increase the     utilization of OVA1® and support the launch of ASPiRA LABS.   oAnnounced the publication by The American Journal of Obstetrics &     Gynecology of a new clinical study titled, "The Effect of Ovarian Imaging     on the Clinical Interpretation of a Multivariate Index Assay," which     addresses the relationship between imaging and OVA1 in assessing risk of     ovarian cancer and provides additional evidence that helps physicians and     health care providers understand the clinical value of OVA1.   oAppointed Vermillion's chairman of the board, James LaFrance, as the     company's president and chief executive officer, effective as of April 23,     2014, as Vermillion transitions to a phase where commercial build out and     execution is of paramount importance. Mr. LaFrance has had a highly     successful track record that spans 30 years of diagnostic experience,     predominantly in sales, marketing and general management.  Management Commentary "During the quarter, we advanced our OVA1 commercialization strategy on multiple fronts," said James LaFrance, Vermillion's chairman, president and CEO. "We formed ASPiRA LABS, our own national CLIA laboratory.  "We believe ASPiRA will enable us to control the entire customer experience and allow us direct access to payers. We believe this new lab, coupled with an increased sales presence in the field, represents a tremendous opportunity to increase adoption and awareness of OVA1.  Q1 2014 Financial Results Total revenue in the first quarter of 2014 was $305,000, as compared to $328,000 in the same year-ago period. First quarter 2014 revenue was comprised of $191,000 in OVA1 product revenue and $114,000 in license revenue.  The product revenue in the first quarter of 2014 was derived from 3,817 OVA1 tests performed at the fixed $50 per test as reported by Quest Diagnostics, which compares to product revenue in the first quarter of 2013 that was derived from 4,274 OVA1 tests. The decrease in test volume was primarily due to Vermillion's reorganization of its sales staff prior to the launch of ASPiRA LABS. The company expects ASPiRA LABS activity to increase product revenue in the second half of 2014 and as supported by an expanded sales team.  OVA1 product revenue in both the first quarter of 2014 and the year-ago period does not include the additional royalty component of revenue based on 33% of Quest Diagnostics gross margin. Vermillion will recognize this portion of revenue when it is reported by Quest Diagnostics in an annual 'true-up' after the end of the calendar year. The true-up is based on reimbursed and unreimbursed tests for which Quest Diagnostics considers the payment status as final.  Total operating expenses in the first quarter of 2014 increased to $4.2 million from $2.9 million in the year-ago quarter. The increase was primarily due to greater research and development headcount and increased collaboration costs with Johns Hopkins University to advance Vermillion's platform migration and next-generation test, as well as costs attributed to the formation and branding of ASPiRA LABS.  Net loss for the first quarter was $4.0 million or $(0.11) per share, as compared to a net loss of $2.6 million or $(0.17) per share in the year-ago quarter.  As of March 31, 2014, cash and equivalents totaled $26.0 million. The company used $3.5 million in cash for operations in the first quarter of 2014, and expects to utilize $3.3 million to $3.8 million in cash in the second quarter of 2014.  Conference Call and Webcast Vermillion will hold a conference call to discuss its first quarter results later today, Thursday, May 15, 2014, at 4:30 p.m. Eastern time. Vermillion's Chairman, President and CEO James LaFrance will host the call, followed by a question and answer period.  Date: Thursday, May 15, 2014 Time: 4:30 p.m. Eastern time (3:30 p.m. Central time) Dial-in number: 1-800-772-3714 International dial-in number: 1-212-231-2920 Conference ID: 21715661 Webcast: http://edge.media-server.com/m/p/4dkdqqv3/lan/en  The conference call will be webcast live and available for replay via the investor section of the company's website at www.vermillion.com.  Please call the conference telephone number five minutes prior to the start time. An operator will register your name and organization. If you have any difficulty connecting with the conference call, please contact Liolios Group at 1-949-574-3860.  A replay of the call will be available approximately two hours after the call until May 29, 2014.  Toll-free replay number: 1-800-633-8284 International replay number: 1-402-977-9140 Replay ID: 21715661  About Vermillion Vermillion, Inc. (NASDAQ: VRML) is dedicated to the discovery, development and commercialization of novel high-value diagnostic tests that help physicians diagnose, treat and improve outcomes for patients. Vermillion, along with its prestigious scientific collaborators, has diagnostic programs in gynecologic oncology and women's health.  The company's lead diagnostic, OVA1®, is a blood test for pre-surgical assessment of ovarian tumors for malignancy, using an innovative algorithmic approach. As the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, OVA1 represents a new class of software-based diagnostics. For additional information, including published clinical trials, visit www.vermillion.com.  Forward-Looking Statements This press release contains forward-looking statements, as that term is defined in the Private Litigation Reform Act of 1995, that involve significant risks and uncertainties, including statements regarding the activities of ASPiRA LABS, Inc., Vermillion's future revenue and Vermillion's expected cash outlay. 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. The forward-looking statements contained in this press release are based on Vermillion's expectations as of the date of this press release. A variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. Factors that could cause actual results to materially differ from those projected in such forward-looking statements include but are not limited to: (1) uncertainty as to Vermillion's ability to protect and promote its proprietary technology; (2) Vermillion's lack of a lengthy track record successfully developing and commercializing diagnostic products; (3) uncertainty as to whether Vermillion will be able to obtain any required regulatory approval of its future diagnostic products or otherwise comply with applicable laws and regulations; (4) uncertainty of the size of market for its existing diagnostic tests or future diagnostic products, including the risk that its products will not be competitive with products offered by other companies, or that users will not be entitled to receive adequate reimbursement for its products from third-party payers such as private insurance companies and government insurance plans; (5) uncertainty that Vermillion has sufficient cash resources to fully commercialize its tests and continue as a going concern; (6) uncertainty regarding Vermillion's ability to generate sufficient demand for ASPiRA LABS' services to cover the laboratory's operating costs; (7) uncertainty whether the trading in Vermillion's stock will become significantly less liquid; and (8) other factors that are described in Vermillion's Form 10-K for the year ended December 31, 2013 and Vermillion's Form 10-Q for the quarter ended March 31, 2014 filed with the Securities and Exchange Commission (the "SEC"). 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.  This release should be read in conjunction with the consolidated financial statements and notes thereto included in our most recent reports on Form 10-K and Form 10-Q. Copies are available through the SEC's Electronic Data Gathering Analysis and Retrieval system (EDGAR) at www.sec.gov.  Investor Relations Contact: Liolios Group, Inc. Ron Both Tel 1-949-574-3860 VRML@liolios.com    Vermillion, Inc.  Consolidated Balance Sheets  (Amounts in Thousands, Except Share and Par Value Amounts)  (Unaudited)                                                      March 31,   December 31,                                                      2014         2013 Assets Current assets: Cash and cash equivalents                           $ 25,991     $  29,504 Accounts receivable                                   169           373 Prepaid expenses and other current assets             728           372 Total current assets                                  26,888        30,249 Property and equipment, net                           384           391 Total assets                                         $ 27,272     $  30,640 Liabilities and Stockholders' Equity Current liabilities: Accounts payable                                    $ 620        $  541 Accrued liabilities                                   1,523         1,283 Short-term debt                                        1,106         1,106 Deferred revenue                                       897           628 Total current liabilities                             4,146         3,558 Deferred revenue                                       202           316 Total liabilities                                     4,348         3,874 Commitments and contingencies Stockholders' equity: Preferred stock, $0.001 par value, 5,000,000 shares authorized, none issued and outstanding at March 31,   —             — 2014 and December31, 2013, respectively Common stock, $0.001 par value, 150,000,000 shares authorized at March 31, 2014 and December31, 2013; 35,831,776 and 35,825,673 shares issued andoutstanding at March 31, 2014 and December 31,     36            36 2013, respectively Additional paid-in capital                            359,139       358,994 Accumulated deficit                                   (336,251)     (332,264) Total stockholders' equity                             22,924        26,766 Total liabilities and stockholders' equity           $ 27,272     $  30,640      Vermillion, Inc.  Consolidated Statements of Operations and Comprehensive Loss  (Amounts in Thousands, Except Share and Per Share Amounts)  (Unaudited)                                                   Three Months Ended March 31,                                                   2014            2013 Revenue: Product                                           $  191          $ 214 License                                              114            114 Total revenue                                        305            328 Cost of revenue: Product                                              55             37 Gross profit                                         250            291 Operating expenses: Research and development^(1)                         1,153          484 Sales and marketing^(2)                              2,104          1,072 General and administrative^(3)                       988            1,337 Total operating expenses                             4,245          2,893 Loss from operations                                 (3,995)        (2,602) Interest income                                      14             2 Other income (expense), net                          (6)            29 Loss before income taxes                             (3,987)        (2,571) Income tax benefit (expense)                         —              — Net loss                                          $  (3,987)      $ (2,571) Net loss per share - basic and diluted            $  (0.11)       $ (0.17) Weighted average common shares used to compute       35,827,886     15,201,616 basic and diluted net loss per common share Non-cash stock-based compensation expense included in operating expenses: (1) Research and development                     $  40           $ 20 (2) Sales and marketing                             25             54 (3) General and administrative                      69             107    SOURCE Vermillion, Inc.  Website: http://www.vermillion.com  
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