Vermillion Reports Third Quarter 2013 Results
AUSTIN, Texas, Nov. 14, 2013
AUSTIN, Texas, Nov. 14, 2013 /PRNewswire/ --Vermillion, Inc. (NASDAQ: VRML),
a multivariate diagnostics company focused on gynecologic cancers and women's
health, reported on its financial results for the third quarter ended
September 30, 2013.
Q3 2013 Financial Results
Total revenue in the third quarter of 2013 was $330,000 compared to $319,000
in the same year-ago quarter. Third quarter 2013 revenue was comprised of
$216,000 in OVA1® product sales and $114,000 in license revenue.
Third quarter of 2013 product revenue was derived from 4,328 OVA1 tests
performed at the fixed $50 per test as reported by Quest Diagnostics. This
represents a 5.6% increase in test volume compared to approximately 4,100 OVA1
tests performed in the year-ago quarter. Although covered lives have decreased
to approximately 67.0 million due to the previously announced BlueCross
BlueShield Technical Evaluation Center position, it did not affect test sale
volumes for the quarter.
The OVA1 product revenue in both periods does not include the additional
royalty component of revenue based on 33% of Quest Diagnostics gross margin.
Vermillion recognizes 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 were $2.6 million in both the third quarter of 2013
and the same year-ago quarter. For the nine months ended September 30, 2013,
total operating expenses were $7.9 million as compared to $9.0 million in the
same year-ago period.
Net loss for the third quarter was $2.3 million or $(0.10) per share, as
compared to a net loss of $2.0 million or $(0.13) per share in the same
year-ago quarter. For the nine months ended September 30, 2013, net loss was
$7.0 million or $(0.36) per share as compared to a net loss of $5.8 million or
$(0.39) per share in the same year-ago period. The prior year included
one-time gains on a sale of an instrument business and a litigation settlement
totaling $2.5 million. As of September 30, 2013, the company had 23.5 million
common shares outstanding.
As of September 30, 2013, cash and equivalents totaled $14.6 million. The
company utilized $1.8 million in cash for operations in the third quarter of
2013, and expects $2.4 million to $2.9 million in cash outlay during the
fourth quarter of 2013 including $0.3 million for the purchase of an IVD
platform for research and development.
Q3 2013 Key Developments
oAdvanced Vermillion's OVA1 platform migration and Next-Generation product
development. The company selected a top-tier IVD instrument for
development as well as expanded its agreement with Johns Hopkins' Center
for Biomarker Discovery and Translation (CBDT). The company will fund $1.6
million to CBDT through June 2015 for assistance with these programs.
oContinued steps to expand the market for OVA1. Vermillion sent Quest
Diagnostics a notice of termination of the Strategic Alliance Agreement on
August 23, 2013, with the proviso that Quest Diagnostics can continue to
provide OVA1 under the existing financial terms while negotiating in good
faith towards an alternative business structure. Quest Diagnostics has
disputed the effectiveness of the termination.
oBroadened Vermillion's sales and reimbursement team by adding an
additional field representative and two managed care directors. The
company now has a total of 10 experienced sales professionals as well as a
team of four reimbursement professionals.
oAppointed Dr. Eric Varma to the board of directors, bringing to the
company significant financial and commercial experience in the Life
Sciences. Dr. Varma is currently a partner at Oracle Investment
Management, Vermillion's largest stockholder.
"We have continued to make progress on the commercialization of OVA1,"
commented Tom McLain, Vermillion's president and CEO. "In sales regions
covered by Vermillion sales reps, test volumes were up more than 15% from the
third quarter of 2012. This reflects the positive impact of the SGO statement
issued in May, new clinical data and our expanded commercial presence.
"In the fourth quarter, our operational focus continues to be on four key
areas: collaborations to develop additional clinical and economic data,
treatment guidelines, favorable coverage decisions and expanding access to our
OVA1 test. We remain confident that the foundation we are building for our
novel diagnostic test will support strong future growth."
Conference Call and Webcast
Vermillion will hold a conference call to discuss its third quarter results
later today, Thursday, November 14, 2013, at 4:30 p.m. Eastern time.
Vermillion's President and CEO Thomas McLain will host the call, followed by a
question and answer period.
Date: Thursday, November 14, 2013
Time: 4:30 p.m. Eastern time (3:30 p.m. Central time)
Dial-in number: 1-800-734-8507
International dial-in number: 1-212-231-2918
Conference ID: 21676489
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 5-10 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
A replay of the call will be available approximately two hours after the call
through November 28, 2013.
Toll-free replay number: 1-800-633-8284
International replay number: 1-402-977-9140
Replay ID: 21676489
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,
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 Vermillion's expected
cash outlay and Vermillion's ability to regain traction in reimbursement.
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; (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 whether the trading in Vermillion's stock will become
significantly less liquid; and (7) other factors that are described in
Vermillion's Form 10-Q for the quarter ended March 31, 2013, filed with the
Securities and Exchange Commission. 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.
Consolidated Balance Sheets
(Amounts in Thousands, Except Share and Par Value Amounts)
September 30, December 31,
Cash and cash equivalents $ 14,604 $ 8,007
Accounts receivable 166 137
Prepaid expenses and other current assets 227 348
Total current assets 14,997 8,492
Property and equipment, net 87 142
Total assets $ 15,084 $ 8,634
Liabilities and Stockholders' Equity
Accounts payable $ 422 $ 525
Accrued liabilities 1,485 1,074
Short-term debt 1,106 1,106
Deferred revenue 1,397 492
Total current liabilities 4,410 3,197
Deferred revenue 429 770
Total liabilities 4,839 3,967
Commitments and contingencies
Preferred stock, $0.001 par value, 5,000,000
shares authorized, none issued and outstanding at
September 30, 2013 and December31, 2012, — —
Common stock, $0.001 par value, 150,000,000 shares
authorized at September 30, 2013 and December31,
2012; 23,487,927 and 15,200,079 shares issued and
outstanding at September 30, 2013 and December 31, 23 15
Additional paid-in capital 340,669 328,097
Accumulated deficit (330,447) (323,445)
Total stockholders' equity 10,245 4,667
Total liabilities and stockholders' equity $ 15,084 $ 8,634
Consolidated Statements of Operations and Comprehensive Loss
(Amounts in Thousands, Except Share and Per Share Amounts)
Three Months Ended September Nine Months Ended
30, September 30,
2013 2012 2013 2012
Product $ 216 $ 205 $ 640 $ 611
License 114 114 341 341
Total revenue 330 319 981 952
Cost of revenue:
Product 25 33 96 99
Total cost of revenue 25 33 96 99
Gross profit 305 286 885 853
Research and 553 429 1,591 1,883
Sales and 1,180 1,082 3,172 3,722
General and 889 1,073 3,160 3,381
Total operating 2,622 2,584 7,923 8,986
Loss from operations (2,317) (2,298) (7,038) (8,133)
Interest income 7 7 15 23
Interest expense — (66) — (197)
Gain on sale of — 50 — 1,830
Gain on litigation — 331 — 710
Reorganization items — — — 88
Other income (4) (45) 21 (92)
Loss before income (2,314) (2,021) (7,002) (5,771)
Income tax benefit — — — —
Net loss $ (2,314) $ (2,021) $ (7,002) $ (5,771)
Net loss per share - $ (0.10) $ (0.13) $ (0.36) $ (0.39)
basic and diluted
common shares used to
compute 23,486,496 15,057,027 19,472,105 14,972,877
basic and diluted
net loss per common
Net loss (2,314) (2,021) (7,002) (5,771)
translation — — — (1)
Comprehensive Loss $ (2,314) $ (2,021) $ (7,002) $ (5,772)
(1) Research and $ 12 $ 25 $ 44 $ 99
(2) Sales and 32 55 118 148
(3) General and 22 168 143 552
SOURCE Vermillion, Inc.
Press spacebar to pause and continue. Press esc to stop.