PARSIPPANY, N.J., May 15, 2017 /PRNewswire/ -- Interpace
Diagnostics Group, Inc. (IDXG) ("Interpace" or "the Company"), a
fully integrated commercial company that provides clinically useful
molecular diagnostic tests and pathology services for improved
patient diagnosis and management, today announced financial results
and business progress for the quarter ended March 31, 2017, as well as recent
accomplishments.
"Continued commercial progress while managing costs to
acceptable levels resulted in good financial performance for the
quarter," said Jack Stover,
Interpace's President & CEO. Our restructuring and
recapitalization plans were transformational and included raising
over $14 million in new capital since
late December, completely eliminating over $9.3 million of secured debt, reducing total
liabilities by over $12 million since
year end and adding in excess of $24
million to stockholders' equity at March 31, 2017 while terminating significant
future potential royalties and milestones related to assets
acquired in 2014," noted Stover. "Additionally, gaining
reimbursement for our ThyraMIR assay with UnitedHealthcare, the
largest healthcare insurer in the US, was critically important,"
added Mr. Stover.
Q1 2017 Financial Performance
- Revenue for the three month period ended March 31, 2017 was $3.5
million, an increase of 14% over the same prior year period
and 11% over the last quarter of 2016.
- Income from Continuing Operations grew to $1.9 million in 2017 up from $ (4.0) million in the prior year's quarter due
principally to a $5.8 million
reduction in fair value of contingent consideration as a result of
the reduction of potential royalties and milestones related to
assets acquired in 2014.
- Total Assets grew by $5.2
million while at the same time total liabilities were
reduced by over $12 million compared
to year end.
- Cash balances improved to over $7
million at quarter's end.
- Net cash used in operations for the quarter amounted to
$4.1 million in Q1-2017 as compared
to $4.0 million in 2016. Included in
cash used in the first quarter of 2017 was approximately
$2.5 million of expenditures related
to discontinued operations, transaction fees and payment
obligations carried over from the contract sales organization (CSO)
business we sold in 2015.
- Total stockholders' equity grew by over $18 million since year end 2016.
- Adjusted EBITDA (in the attached schedule), which we believe
is a meaningful supplemental disclosure that may be indicative of
how management and our Board of Directors evaluate Company
performance, adjusts Income or Loss from Continuing Operations for
non-cash charges such as depreciation & amortization, asset
impairment, loss on extinguishment, goodwill impairment and the
change in fair value of contingent consideration. Accordingly, our
Adjusted EBITDA for the three-month periods ended March 31, 2017 and 2016 was $(1.1) million and $(2.6)
million,respectively, demonstrating continued operating
improvement.
First Quarter 2017 and Recent Business Highlights
- Announced that UnitedHealthcare, the largest health plan in
the United States, has agreed to
cover Interpace's ThyraMIR test for all of United's members
nationwide. Interpace's ThyGenX and ThyraMIR thyroid assays
are now covered for approximately 250 million patients
nationwide.
- Entered into an agreement with a major Healthcare system in
Philadelphia for our two molecular
tests for indeterminate thyroid nodules, ThyGenX and ThyraMIR.
- The European Patent Office granted a Patent for use of
microRNAs for distinguishing benign from malignant thyroid
neoplasms. This patent covers the underlying technology of the
Company's ThyraMIR® microRNA Classifier.
- Entered into an exclusive distribution agreement in
Israel with Best Med Opinion Ltd
(Best Med) of Tel Aviv, Israel, a
provider of second opinion and clinical services for physicians and
patients in Israel and several
other countries.
- Announced entrée into expanding our commercial footprint
internationally as a result of the adoption of the ThyGenX test by
Dr. Richard Payne of Montreal, Quebec. This is the Company's
initial step in launching its Thyroid products in Canada.
- Participated in a major awareness campaign on Endocrine Health
published in a "special insert" in in the March 17-19th edition of USA Today.
- Six abstracts were accepted and presented as posters at the
Digestive Disease Week (DDW) meeting being held May 6th-9th, 2017 in Chicago, Illinois. Three of the accepted
abstracts address the clinical utility of PancraGEN™ in assessing
long-term risk of malignancy in pancreatic cystic lesions in
various real-world clinical scenarios and include data from 370
patients who underwent multiple PancraGEN tests over the course of
3 years. Three additional posters describe the expanded use of
PancraGEN as an ancillary test for solid lesions of the pancreas
and bile duct using the Company's unique method for testing
free-DNA obtained from bile duct brushings and fine needle
aspirates. Notably, the abstracts describe results from a registry
study of over 200 patients and a prospective study of 100 patients
who received such testing for solid pancreaticobiliary
lesions.
About Interpace Diagnostics Group, Inc.
Interpace is a fully integrated commercial 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 improved 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's mission is to
provide personalized medicine through molecular diagnostics and
innovation to advance patient care based on rigorous science. For
more information, please visit Interpace Diagnostics' website at
www.interpacediagnostics.com
About Thyroid Nodules, ThyGenX and ThyraMIR
testing
According to the American Thyroid Association,
approximately 15% to 30% of the 525,000 thyroid fine needle
aspirations (FNAs) performed on an annual basis in the U.S. are
indeterminate for malignancy based on standard cytological
evaluation, and thus are candidates for ThyGenX and ThyraMIR.
ThyGenX and ThyraMIR reflex testing yields high predictive value
in determining the presence and absence of cancer in thyroid
nodules. The combination of both tests can improve risk
stratification and surgical decision-making when standard
cytopathology does not provide a clear diagnosis for the presence
of cancer.
ThyGenX utilizes 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 cancer. ThyraMIR is the first microRNA 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.
Both ThyGenX and ThyraMIR are covered by both Medicare and
Commercial insurers.
About Pancreatic Cysts and 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 the Company's
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 the Company's control. These statements also involve known
and unknown risks, uncertainties and other factors that may cause
the 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, the Company's ability to adequately finance the
business, its ability to restructure its liabilities and other
obligations, the market's acceptance of its molecular diagnostic
tests, its ability to retain or secure reimbursement, its ability
to secure additional business and generate higher profit margins
through sales of its molecular diagnostic tests, in-licensing or
other means, projections of future revenues, growth, gross profit
and anticipated internal rate of return on investments and its
ability to maintain its NASDAQ listing. Additionally, all
forward-looking statements are subject to the risk factors detailed
from time to time in the Company's filings with the SEC, including
without limitation, the Annual Report on Form 10-K filed with the
SEC on March 31, 2017 and the
Company's 10Q for the quarter ended March
31, 2017 filed with the SEC on May
12, 2017. 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:
Paul Kuntz
Redchip
Paul@Redchip.com
Non-GAAP Financial Measures
In addition to the United
States generally accepted accounting principles, or GAAP,
results provided throughout this document, Interpace has provided
certain non-GAAP financial measures to help evaluate the results of
its performance. We believe that these non-GAAP financial measures,
when presented in conjunction with comparable GAAP financial
measures, are useful to both management and investors in analyzing
the Company's ongoing business and operating performance. We
believe that providing the non-GAAP information to investors, in
addition to the GAAP presentation, allows investors to view the
Company's financial results in the way that management views
financial results.
In this document, we discuss Adjusted EBITDA, a non-GAAP
financial measure. Adjusted EBITDA is a metric used by management
to measure cash flow of the ongoing business. Adjusted EBITDA is
defined as income or loss from continuing operations, plus
depreciation and amortization, non cash stock based compensation,
interest and taxes, and other non-cash expenses including asset
impairment costs, loss on extinguishment of debt, goodwill
impairment and change in fair value of contingent consideration.
The table below includes a reconciliation of this non-GAAP
financial measure to the most directly comparable GAAP financial
measure.
Conference Call
As previously announced, Interpace will hold a conference call
Monday, May 15, 2017 at 4:30 p.m. (ET) to discuss financial and
operational results for the first quarter ended March 31, 2017. Details as follows:
The live webcast and subsequent replay may be accessed by
visiting Interpace's website www.interpacediagnostics.com.
Alternatively, please call 1-877-718-5104 (U.S.) or 1-719-325-4838
(international). The conference ID number is 4151283. The webcast
replay will be available on the company's website approximately two
hours following completion of the call and archived on the
company's website for 90 days.
Interpace
Diagnostics Group, Inc.
|
CONDENSED
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(LOSS)
|
|
(in thousands,
except per share data)
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
March
31,
|
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
|
|
|
|
Revenue,
net
|
$
3,470
|
|
$
3,035
|
|
Cost of
revenue
|
1,771
|
|
1,179
|
|
Gross
profit
|
1,699
|
|
1,856
|
|
Operating
expenses:
|
|
|
|
|
Sales and
marketing
|
1,136
|
|
1,547
|
|
Research and
development
|
306
|
|
323
|
|
General and
administrative
|
1,522
|
|
2,816
|
|
Acquisition related
amortization expense
|
813
|
|
970
|
|
Change in fair value
of contingent consideration
|
(5,776)
|
|
-
|
|
Total operating
expenses
|
(1,999)
|
|
5,656
|
|
|
|
|
|
|
Operating income
(loss)
|
3,698
|
|
(3,800)
|
|
Interest
expense
|
(254)
|
|
(203)
|
|
Loss on
extinguishment of note
|
(1,547)
|
|
-
|
|
Other (loss) income ,
net
|
(36)
|
|
6
|
|
Income (loss) from
continuing operations before tax
|
1,861
|
|
(3,997)
|
|
Provision for income
taxes
|
3
|
|
9
|
|
Income (loss) from
continuing operations
|
1,858
|
|
(4,006)
|
|
Income (loss) from
discontinued operations, net of tax
|
556
|
|
(780)
|
|
Net income
(loss)
|
$
2,414
|
|
$
(4,786)
|
|
|
|
|
|
|
Basic income (loss)
per share of common stock:
|
|
|
|
|
From continuing
operations
|
$
0.43
|
|
$
(2.26)
|
|
From discontinued
operations
|
0.13
|
|
(0.44)
|
|
Net income (loss) per
basic share of common stock
|
$
0.56
|
|
$
(2.69)
|
|
|
|
|
|
|
Diluted income (loss)
per share of common stock:
|
|
|
|
|
From continuing
operations
|
$
0.42
|
|
$
(2.26)
|
|
From discontinued
operations
|
0.13
|
|
(0.44)
|
|
Net income (loss) per
diluted share of common stock
|
$
0.55
|
|
$
(2.69)
|
|
Weighted average
number of common shares and
|
|
|
|
|
common share
equivalents outstanding:
|
|
|
|
|
Basic
|
4,294
|
|
1,776
|
|
Diluted
|
4,384
|
|
1,776
|
|
Selected Balance
Sheet Data
|
($ in
thousands)
|
|
|
|
|
|
March
31
|
|
December
31,
|
|
2017
|
|
2016
|
Cash and cash
equivalents
|
$
7,126
|
|
$
602
|
|
|
|
|
Total current
assets
|
10,659
|
|
4,240
|
Total current
liabilities
|
13,024
|
|
16,241
|
|
|
|
|
Total
assets
|
46,975
|
|
41,778
|
Total
liabilities
|
22,406
|
|
35,247
|
Total stockholders'
(deficit) equity
|
24,569
|
|
6,531
|
Selected Cash Flow
Data
|
($ in
thousands)
|
|
|
|
For the Three
Months Ended
|
|
March
31,
|
|
2017
|
|
2016
|
Net income
(loss)
|
$
2,414
|
|
$
(4,786)
|
|
|
|
|
Net cash used in
operating activities
|
$
(4,149)
|
|
$
(3,970)
|
Net cash used in
investing activities
|
-
|
|
-
|
Net cash provided by
financing activities
|
10,673
|
|
-
|
Change in cash and
cash equivalents
|
6,524
|
|
(3,970)
|
Cash and equivalents,
beginning
|
602
|
|
8,310
|
Cash and equivalents,
ending
|
$
7,126
|
|
$
4,340
|
Reconciliation of
Adjusted EBITDA (Unaudited)
|
($ in
thousands)
|
|
|
|
|
|
|
|
|
|
|
Quarters
Ended
|
|
|
|
|
March
31,
|
|
|
|
|
2017
|
|
2016
|
|
Income (loss) from
continuing operations
|
$
1,858
|
|
$
(4,006)
|
|
Depreciation and
amortization- continuing operations
|
972
|
|
1,100
|
|
Stock-based
compensation - continuing operations
|
58
|
|
67
|
|
Taxes
|
|
|
3
|
|
9
|
|
Interest
expense
|
|
|
254
|
|
203
|
|
Loss on
extinguishment of note
|
|
1,547
|
|
-
|
|
Change in fair value
of contingent consideration
|
(5,776)
|
|
-
|
|
Adjusted
EBITDA
|
|
|
$
(1,084)
|
|
$
(2,627)
|
|
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SOURCE Interpace Diagnostics Group, Inc.