PARSIPPANY, N.J., Nov. 18, 2016 /PRNewswire/ -- Interpace
Diagnostics Group (NASDAQ: IDXG), a company that provides
clinically useful molecular diagnostic tests and pathology services
for evaluating risk of cancer by leveraging the latest technology
in personalized medicine for better patient diagnosis and
management, today reported financial and operational results for
the third quarter ended September 30,
2016.
Operational and Cash Update:
- The company has been reducing operational costs and working
to restructure obligations incurred related to the sale of the
majority of the CSO business in December
2015 as well as obligations related to the acquisition of
RedPath. Quarterly installment payments due on the $10.7 million secured note payable to the RedPath
shareholders, originally due beginning October 1, 2016, have been extended to begin on
December 31, 2016.
- The company had cash balances of $1.7
million on September 30, 2016
and has negotiated a line of credit of up to $1.2 million and has not drawn down on the
facility to date.
Recent Business Updates Include:
- Evidence supporting Interpace Diagnostics' PanDNA product
presented at the American College of Gastroentrerology Annual
Meeting by Dr. James Farrell,
Director of the Yale Center for Pancreatic Diseases, described when
and how PanDNA can help assess long term risk of pancreatic cancer
in patients with pancreatic cyst lesions.
- Completed the validation and launch of two new thyroid
services designed to assist physicians and clinics that prefer
to have the initial Fine Needle Aspirate (FNA) biopsy assessed by
an independent third party.
- Announced New York State
approval of ThyGenX™ for indeterminate thyroid nodules
in October enabling us to now market both ThyGenX and ThyraMir in
the state, which is known to account for approximately 5% of the
600,000 FNA biopsies in the US annually.
"During the third quarter, our team continued to perform.
Significant new product extensions are being brought to market
which, we believe, will keep us on track to meeting our revenue
goals. While Q-3 revenues were slightly less than anticipated, we
are seeing strong performance in the first month of the fourth
quarter," said Jack E. Stover,
President & CEO. "We are hopeful that further
restructurings can be accomplished in a timely manner and
accordingly we are continuing to aggressively seek and evaluate
strategic alternatives."
Financial Update:
Interpace's net revenue for the third quarter of 2016 was
$3.3 million, an increase of 32%
compared to $2.5 million in the third
quarter of 2015 and down 8% from the second quarter of 2016. Gross
profit for the period was $1.5
million, or 44.0% of net revenue, as compared to
$0.7 million, or 28% of net revenue
in the prior year period. Total operating expenses for the period
increased to $8.0 million from
$7.4 million for the same period in
2015. Included in operating expenses in the third quarter of 2016
was a $3.4 million non cash asset
impairment charge. The loss from continuing operations, before tax
for the third quarter of 2016, was $7.0
million, compared to the $7.6 million loss in the third
quarter of 2015. The net loss for the third quarter of 2016 was
$7.5 million, as compared to a net
loss of $4.9 million for the
comparable period of 2015, which included $2.6 million of income from discontinued
operations in 2015. Net cash used in operating activities for the
nine months ended September 30, 2016
was $6.6 million of which
$5.1 million was from continuing
operations, a substantial improvement as compared to $13.5 million for the prior year period.
About Interpace Diagnostics Group, Inc.
Interpace Diagnostics provides clinically useful molecular
diagnostic tests and pathology services for evaluating risk of
cancer by leveraging the latest technology in personalized medicine
for better patient diagnosis and management. The Company currently
has three commercialized molecular tests: PancraGen® for the
evaluation of pancreatic cysts and assessment of risk of
concomitant or subsequent cancer; ThyGenX®, for the diagnosis
of thyroid cancer from thyroid nodules utilizing a next generation
sequencing assay; and ThyraMIR®, for the diagnosis of thyroid
cancer from thyroid nodules utilizing a proprietary gene expression
assay. Interpace Diagnostics mission is to provide personalized
medicine through molecular diagnostics and innovation to advance
patient care based on rigorous science.
ThyGenX® Oncogene Panel
ThyGenX® is used to improve risk
stratification and surgical decision-making when standard
cytopathology does not provide a clear diagnosis of thyroid cancer.
Accordingly, ThyGenX® assists physicians in
distinguishing between benign and malignant genotypes in
indeterminate thyroid nodules by utilizing state-of-the-art
next-generation sequencing (NGS) to identify more than 100 genetic
alterations associated with papillary and follicular thyroid
carcinomas, the two most common forms of thyroid malignancies. The
ThyGenX® panel design is based on the
miRInform® test, whose high predictive value
has been validated in a recent prospective clinical study involving
over 600 patients. Interpace Diagnostics acquired the
miRInform test from Asuragen in 2014, and the test has
subsequently been upgraded to an NGS platform, providing greater
genomic insights and increased panel content.
ThyraMIR® Micro RNA
Classifier
ThyraMIR® miRNA Classifier is the first gene
expression classifier. MicroRNAs are small, non-coding RNAs
that bind to messenger RNA and regulate expression of genes
involved in human cancers, including every subtype of thyroid
cancer. ThyraMIR® measures the expression of 10
microRNAs and, when used in combination with
ThyGenX®, yields high negative predictive value
and high positive predictive value. This results in improved
molecular classification of both benign and malignant thyroid
nodules independent of thyroid cancer prevalence in the clinical
setting.
About PancraGEN®
PancraGEN® is a pancreatic cyst molecular test
that, by using a small sample of pancreatic cyst fluid, can aid in
pancreatic cancer risk assessment. PancraGEN® is
90% accurate, according to clinical studies, enabling effective
risk stratification of patients. Pancreatic cancer is often
difficult to diagnose in early stages and typically spreads rapidly
with signs and symptoms appearing when the cancer is significantly
advanced. Because of this, and that complete surgical removal of
the pancreas is not possible, pancreatic cancer is considered a
leading cause of cancer deaths.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, Section
21E of the Securities Exchange Act of 1934 and the Private
Securities Litigation Reform Act of 1995, relating to our future
financial and operating performance. The company has attempted to
identify forward looking statements by terminology including
"believes," "estimates," "anticipates," "expects," "plans,"
"projects," "intends," "potential," "may," "could," "might,"
"will," "should," "approximately" or other words that convey
uncertainty of future events or outcomes to identify these
forward-looking statements. These statements are based on
current expectations, assumptions and uncertainties involving
judgments about, among other things, future economic, competitive
and market conditions and future business decisions, all of which
are difficult or impossible to predict accurately and many of which
are beyond company's control. These statements also involve known
and unknown risks, uncertainties and other factors that may cause
company's actual results to be materially different from those
expressed or implied by any forward-looking statement. Known and
unknown risks, uncertainties and other factors include, but are not
limited to, our ability to adequately finance the business, our
ability to restructure our debt and other obligations, our ability
to find a buyer of our assets, the market's acceptance of our
molecular diagnostic tests, our ability to secure additional
business and generate higher profit margins through sales of our
molecular diagnostic tests, in-licensing or other means,
projections of future revenues, growth, gross profit and
anticipated internal rate of return on investments. Additionally,
all forward-looking statements are subject to the risk factors
detailed from time to time in the company's periodic filings with
the Securities and Exchange Commission (SEC), including without
limitation, the Annual Report on Form 10-K filed with the SEC on
March 30, 2016, as amended on
April 29, 2016 and June 14, 2016. Because of these and other
risks, uncertainties and assumptions, undue reliance should not be
placed on these forward-looking statements. In addition, these
statements speak only as of the date of this press release and,
except as may be required by law, the Company undertakes no
obligation to revise or update publicly any forward-looking
statements for any reason.
CONTACTS:
Interpace Diagnostics
Investor Relations:
Victor Roberts
RedChip Companies, Inc.
(407) 644-4256
victor@RedChip.com
Interpace
Diagnostics Group, Inc.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(in thousands,
except per share data)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
September
30,
|
|
September
30,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
Revenue,
net
|
$
3,316
|
|
$
2,506
|
|
$
9,963
|
|
$
6,876
|
Cost of
revenue
|
1,846
|
|
1,799
|
|
4,866
|
|
5,224
|
Gross
Profit
|
1,470
|
|
707
|
|
5,097
|
|
1,652
|
|
|
|
|
|
|
|
|
Sales and
marketing
|
1,282
|
|
2,876
|
|
4,186
|
|
8,387
|
Research and
development
|
659
|
|
1,000
|
|
1,339
|
|
1,646
|
General and
administrative
|
2,858
|
|
2,498
|
|
7,655
|
|
8,909
|
Acquisition related
amortization expense
|
970
|
|
986
|
|
2,909
|
|
2,825
|
Asset
impairment
|
3,363
|
|
-
|
|
3,363
|
|
-
|
Change in fair value
of contingent consideration
|
(1,174)
|
|
-
|
|
(1,174)
|
|
-
|
Total operating
expenses
|
7,958
|
|
7,360
|
|
18,278
|
|
21,767
|
|
|
|
|
|
|
|
|
Operating
loss
|
(6,488)
|
|
(6,653)
|
|
(13,181)
|
|
(20,115)
|
Interest
expense
|
(539)
|
|
(884)
|
|
(1,601)
|
|
(2,616)
|
Other income
(expense), net
|
4
|
|
(112)
|
|
14
|
|
(268)
|
Loss from continuing
operations before tax
|
(7,023)
|
|
(7,649)
|
|
(14,768)
|
|
(22,999)
|
Income tax expense
(benefit)
|
173
|
|
(180)
|
|
(54)
|
|
(430)
|
Loss from continuing
operations
|
(7,196)
|
|
(7,469)
|
|
(14,714)
|
|
(22,569)
|
(Loss) income from
discontinued operations, net of tax
|
(297)
|
|
2,574
|
|
101
|
|
6,828
|
Net loss
|
$
(7,493)
|
|
$
(4,895)
|
|
$
(14,613)
|
|
$
(15,741)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
income (loss) per share of common stock:
|
|
|
|
|
|
|
|
From continuing
operations
|
$
(0.40)
|
|
$
(0.48)
|
|
$
(0.82)
|
|
$
(1.48)
|
From discontinued
operations
|
(0.02)
|
|
0.16
|
|
0.01
|
|
0.45
|
Net loss per basic
and diluted share of common stock
|
$
(0.41)
|
|
$
(0.31)
|
|
$
(0.81)
|
|
$
(1.03)
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares and
|
|
|
|
|
|
|
|
common share
equivalents outstanding:
|
|
|
|
|
|
|
|
Basic and
Diluted
|
18,163
|
|
15,654
|
|
18,029
|
|
15,301
|
Selected Balance
Sheet Data
|
($ in
thousands)
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
2016
|
|
2015
|
Cash and cash
equivalents
|
$
1,693
|
|
$
8,310
|
|
|
|
|
Total current
assets
|
6,683
|
|
19,165
|
Total current
liabilities
|
19,870
|
|
23,373
|
|
|
|
|
Total
assets
|
45,964
|
|
67,712
|
Total
liabilities
|
47,443
|
|
54,674
|
Total stockholders'
(deficit) equity
|
(1,479)
|
|
13,038
|
|
|
|
|
|
|
|
|
Selected Cash Flow
Data
|
($ in
thousands)
|
|
|
|
For the Nine
Months Ended
|
|
September
30,
|
|
2016
|
|
2015
|
Net loss
|
$
(14,613)
|
|
$
(15,741)
|
|
|
|
|
Net cash used in
operations
|
$
(6,617)
|
|
$
(13,536)
|
Net cash used in
investing activities
|
-
|
|
(583)
|
Net cash used in
financing activities
|
-
|
|
(37)
|
Change in cash and
cash equivalents
|
(6,617)
|
|
(14,156)
|
Cash and equivalents,
Beginning
|
8,310
|
|
23,111
|
Cash and equivalents,
Ending
|
$
1,693
|
|
$
8,955
|
|
|
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/interpace-diagnostics-reports-third-quarter-2016-results-of-operations-300365905.html
SOURCE Interpace Diagnostics Group