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From the Wires
Vermillion Announces Third Quarter 2008 Financial Results and Business Progress
By: PR Newswire
Nov. 14, 2008 09:00 AM
Third Quarter 2008 Financial Results Total operating expenses decreased in the third quarter of 2008 to The Company's net loss for the third quarter of 2008 was At 2008 Third Quarter Highlights and Accomplishments Vermillion is pleased to report the following developments in its clinical and commercialization diagnostic programs:
-- Ovarian Cancer Diagnostic Program:
-- Vermillion's OVA1(TM) 510(k) pre-market notification application
for its ovarian tumor triage test is currently pending before the
FDA. The OVA1 clinical trial was one of the largest ovarian cancer
studies ever conducted and assessed more than 550 women across 27
clinical sites in the United States.
-- Dr. Zhen Zhang, Associate Professor of Pathology at Johns Hopkins
University School of Medicine presented preliminary data from
Vermillion's OVA1 prospective clinical trial at the International
Gynecologic Cancer Society's 12th Biennial meeting in Bangkok,
Thailand, on October 27, 2008.
-- PAD Diagnostic Program:
-- Vermillion and Stanford Scientists received the "Best Clinical
Research Award" from the PAD Coalition for their discovery of
novel biomarkers for peripheral artery disease ("PAD") at its
Annual Meeting in Washington DC on September 8, 2008.
-- Results from Vermillion's 540-subject validation study were
published in the peer-reviewed journal, Vascular Medicine, in
August 2008.
-- Corporate Developments:
-- Vermillion extended the base term of its strategic alliance
agreement with Quest Diagnostics through September 2009. This
extension allows both parties to continue focusing on the market
launch of Vermillion's two lead products -- OVA1 "the ovarian
cancer test" and VASCLIR "the PAD test."
-- Vermillion retained an Interim Chief Financial Officer and an
Interim Vice President of Sales & Marketing.
"We continue to diligently manage expenses and cash utilization while
focusing on our OVA1 clinical trial submission. With the renewal of our
strategic alliance, we look forward to working with Quest Diagnostics to bring
both OVA1 and VASCLIR to the market," said About Vermillion Vermillion, Inc. 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 oncology,
hematology, cardiology and women's health. Vermillion is based in Forward-Looking Statements This news release contains forward-looking statements that involve significant risks and uncertainties, including statements regarding Vermillion's plans, objectives, expectations and intentions. These forward-looking statements are based on Vermillion's current expectations. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for such forward-looking statements. In order to comply with the terms of the safe harbor, Vermillion notes that 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. There are no guarantees that Vermillion will succeed in its efforts to commercialize ovarian cancer or PAD diagnostics products in 2008 or during any other period of time. Factors that could cause actual results to materially differ include but are not limited to: (1) uncertainty in obtaining intellectual property protection for inventions made by Vermillion; (2) unproven ability of Vermillion to discover, develop, and commercialize ovarian cancer or PAD diagnostic products based on findings from its disease association studies; (3) unproven ability of Vermillion to discover or identify new protein biomarkers and use such information to develop ovarian cancer or PAD diagnostic products; (4) uncertainty as to whether Vermillion will be able to obtain any required regulatory approval of its ovarian cancer or PAD diagnostic products; (5) uncertainty of market acceptance of its ovarian cancer or PAD 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 payors such as private insurance companies and government insurance plans; and (6) other factors that might be described from time to time in Vermillion's filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Vermillion expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in Vermillion's expectations or any change in events, conditions or circumstances on which any such statement is based, unless required by law.
- Financial statements follow -
Vermillion, Inc. and Subsidiaries
Consolidated Balance Sheets
(Amounts in Thousands, Except Share and Par Value Amounts)
(Unaudited)
September 30, December 31,
2008 2007
Assets
Current assets:
Cash and cash equivalents $1,877 $7,617
Short-term investments, at fair value - 8,875
Accounts receivable 31 19
Prepaid expenses and other current assets 814 1,064
Total current assets 2,722 17,575
Property, plant and equipment, net 742 1,938
Long-term investments, at fair value 3,552 3,902
Other assets 134 638
Total assets $7,150 $24,053
Liabilities and Stockholders' Deficit
Current liabilities:
Accounts payable $1,126 $2,975
Accrued liabilities 2,056 3,595
Current portion of convertible senior notes,
net of discount 2,500 2,471
Total current liabilities 5,682 9,041
Long-term debt owed to related party 10,000 10,000
Convertible senior notes, net of discount 16,333 16,196
Other liabilities - 278
Total liabilities 32,015 35,515
Stockholders' deficit:
Common stock 6 6
Additional paid-in capital 228,402 227,895
Accumulated deficit (253,193) (239,142)
Accumulated other comprehensive loss (80) (221)
Total stockholders' deficit (24,865) (11,462)
Total liabilities and stockholders' deficit $7,150 $24,053
(1) The condensed consolidated balance sheet at December 31, 2007, has
been derived from the audited consolidated financial statements at
that date included in the Company's Annual Report on Form 10-K for
the fiscal year ended December 31, 2007.
Vermillion, Inc. and Subsidiaries
Consolidated Statements of Operations
(Amounts in Thousands, Except Share and Per Share Amounts)
(Unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2008 2007 2008 2007
Revenue:
Products $5 $- $10 $-
Services 66 - 114 21
Total revenue 71 - 124 21
Cost of revenue:
Products 2 - 4 -
Services - - 20 15
Total cost of revenue 2 - 24 15
Gross profit 69 - 100 6
Operating expenses:
Research and development 1,135 2,181 4,262 6,390
Sales and marketing 388 517 1,784 1,347
General and administrative 1,581 2,090 5,062 8,626
Total operating expenses 3,104 4,788 11,108 16,363
Loss on sale of instrument
business - - - (382)
Loss from operations (3,035) (4,788) (11,008) (16,739)
Interest income 79 169 360 458
Interest expense (508) (596) (1,561) (1,727)
Loss on investments in
auction rate securities (1,124) - (1,748) -
Other income (expense), net (142) 95 (128) 17
Loss before income taxes (4,730) (5,120) (14,085) (17,991)
Income tax benefit (expense) (14) 3 34 1
Net loss $(4,744) $(5,117) $(14,051) $(17,990)
Loss per share
- basic and diluted (1) $(0.74) $(1.06) $(2.20) $(4.26)
Shares used to compute
basic and diluted loss
per common share (1) 6,382,166 4,805,658 6,381,290 4,221,424
(1) Adjusted for March 4, 2008, 1 for 10 reverse stock split.
SOURCE Vermillion, Inc. Latest Cloud Developer Stories
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