PR Newswire
PARSIPPANY, N.J., March 29, 2017
PARSIPPANY, N.J., March 29, 2017 /PRNewswire/ -- Interpace Diagnostics Group, Inc. (NASDAQ: 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 and full year ended December 31, 2016 as well as recent accomplishments.
"2016 was a breakout year as we delivered strong revenue growth, significant cost reductions and right sizing as we completed our transition to a fully-integrated, commercially based molecular diagnostics company," said Jack Stover, Interpace's President & CEO. "Since the latter end of December we have raised $14 million in gross equity and restructured over $9.3 million of secured debt to further strengthen our balance sheet," said Stover. "We are confident that we now have a strong basis as well as momentum into 2017 especially with our recent accomplishments, including New York State and AETNA approvals of ThyraMIR®, our microRNA assay, that is complementary to ThyGenX®," said Stover.
Q4 and 2016 Year End Financial Performance
2016 and Recent Business Highlights
Reimbursement:
Commercial Expansion:
Clinical Evidence
Other Business Progress:
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 debt and other obligations, the market's acceptance of its molecular diagnostic tests, 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 our ability to maintain our 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 30, 2016 as amended on April 20. 2016 and June 14, 2016, the Quarterly Report on Form 10-Q filed with the SEC on November 17, 2016, the prospectus supplements and accompanying prospectuses related to our recent public offerings that were filed with the SEC, and the Annual Report on Form 10-K relating to our year ended December 31, 2016 to be filed with the SEC on March 31, 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
[email protected]
INTERPACE DIAGNOSTICS GROUP, INC. | |||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) | |||||||
(in thousands, except per share data) | |||||||
Three Months Ended |
Years Ended | ||||||
December 31, |
December 31, | ||||||
2016 |
2015 |
2016 |
2015 | ||||
Revenue, net |
$ 3,122 |
$ 2,556 |
$ 13,085 |
$ 9,432 | |||
Cost of revenue |
1,774 |
1,686 |
6,641 |
6,910 | |||
Gross Profit |
1,348 |
870 |
6,444 |
2,522 | |||
Sales and marketing |
1,276 |
1,971 |
5,462 |
10,358 | |||
Research and development |
308 |
646 |
1,647 |
2,292 | |||
General and administrative |
2,848 |
6,514 |
10,504 |
16,922 | |||
Acquisition related amortization expense |
862 |
986 |
3,770 |
3,812 | |||
Asset impairment |
- |
- |
3,363 |
- | |||
Loss on extinguishment of debt |
- |
1,873 |
- |
1,873 | |||
Goodwill impairment |
- |
15,666 |
- |
15,666 | |||
Change in fair value of contingent consideration |
(10,686) |
(7,993) |
(11,860) |
(7,993) | |||
Total operating expenses |
(5,392) |
19,663 |
12,886 |
42,930 | |||
Operating income (loss) |
6,740 |
(18,793) |
(6,442) |
(40,408) | |||
Interest expense |
(544) |
(898) |
(2,144) |
(3,705) | |||
Other income (expense), net |
- |
(17) |
14 |
(93) | |||
Loss from continuing operations before tax |
6,196 |
(19,708) |
(8,572) |
(44,206) | |||
Income tax benefit |
(108) |
(449) |
(162) |
(13,136) | |||
Income (loss) from continuing operations |
6,304 |
(19,259) |
(8,410) |
(31,070) | |||
Discontinued Operations |
|||||||
Income (loss) from discontinued operations |
120 |
2,227 |
(886) |
10,341 | |||
Gain on sale of assets |
- |
21,417 |
1,326 |
21,634 | |||
Income from discontinued operations |
120 |
23,644 |
440 |
31,975 | |||
Provision for income tax on discontinued operations |
143 |
- |
362 |
12,261 | |||
Income from discontinued operations, net of tax |
$ (23) |
$ 23,644 |
$ 78 |
$ 19,714 | |||
Net income (loss) |
$ 6,281 |
$ 4,385 |
$ (8,332) |
$ (11,356) | |||
Basic income (loss) per share of common stock: |
|||||||
From continuing operations |
$ 3.40 |
$ (12.04) |
$ (4.63) |
$ (20.07) | |||
From discontinued operations |
(0.01) |
14.79 |
0.04 |
12.74 | |||
Net Income (loss) per basic share of common stock |
$ 3.39 |
$ 2.74 |
$ (4.59) |
$ (7.34) | |||
Diluted income (loss) per share of common stock: |
|||||||
From continuing operations |
$ 3.25 |
$ (12.04) |
$ (4.63) |
$ (20.07) | |||
From discontinued operations |
(0.01) |
14.79 |
0.04 |
12.74 | |||
Net income (loss) per diluted share of common stock |
$ 3.24 |
$ 2.74 |
$ (4.59) |
$ (7.34) | |||
Weighted average number of common shares and |
|||||||
common share equivalents outstanding: |
|||||||
Basic |
1,855 |
1,599 |
1,816 |
1,548 | |||
Diluted |
1,941 |
1,599 |
1,816 |
1,548 | |||
Selected Balance Sheet Data (Unaudited) | |||
($ in thousands) | |||
December 31, |
December 31, | ||
2016 |
2015 | ||
Cash and cash equivalents |
$ 602 |
$ 8,310 | |
Total current assets |
4,240 |
19,165 | |
Total current liabilities |
16,241 |
23,373 | |
Total assets |
41,778 |
67,712 | |
Total liabilities |
35,247 |
54,674 | |
Total stockholders equity |
6,531 |
13,038 | |
Selected Cash Flow Data (Unaudited) | |||
($ in thousands) | |||
For the Years Ended | |||
December 31, | |||
2016 |
2015 | ||
Net loss |
$ (8,332) |
$ (11,356) | |
Net cash used in operations |
$ (8,940) |
$ (19,842) | |
Net cash provided by investing activities |
- |
26,398 | |
Net cash provided by (used in) financing activities |
1,232 |
(21,357) | |
Change in cash and cash equivalents |
(7,708) |
(14,801) | |
Cash and equivalents, Beginning |
8,310 |
23,111 | |
Cash and equivalents, Ending |
$ 602 |
$ 8,310 | |
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.
Reconciliation of Adjusted EBITDA (Unaudited) | |||||||||
($ in thousands) | |||||||||
Quarters Ended |
Years Ended | ||||||||
December 31, |
December 31, | ||||||||
2016 |
2015 |
2016 |
2015 | ||||||
Income (loss) from continuing operations |
$ 6,304 |
$ (19,259) |
$ (8,410) |
$ (31,070) | |||||
Depreciation and amortization- continuing operations |
992 |
1,136 |
4,292 |
4,470 | |||||
Stock-based compensation - continuing operations |
23 |
2,138 |
131 |
3,128 | |||||
Taxes |
(108) |
# |
(449) |
(162) |
# |
(13,136) | |||
Interest expense |
544 |
898 |
2,144 |
3,705 | |||||
Asset impairment |
- |
- |
3,363 |
- | |||||
Loss on extinguishment of debt |
- |
1,873 |
- |
1,873 | |||||
Goodwill impairment |
- |
15,666 |
- |
15,666 | |||||
Change in fair value of contingent consideration |
(10,686) |
(7,993) |
(11,860) |
(7,993) | |||||
Adjusted EBITDA |
$ (2,931) |
$ (5,990) |
$ (10,502) |
$ (23,357) | |||||
Conference Call
As previously announced, Interpace will hold a conference call Wednesday, March 29, 2017 at 4:30 PM (ET) to discuss financial and operational results for the fourth quarter and the year ended December 31, 2016. Details as follows:
Time: 4:30 PM (ET)
Dial-in numbers: toll free: 1-877-397-0272 toll/international 1-719-325-4751
Conference ID#: 6214396
Replay Dial In of the Call will be available for two weeks from 7:30 PM (ET) on March 29, 2017, until 11:59 PM ET on April 12, 2017. The number for the replay is (844) 512-2921 or (412) 317-6671 for International calls; the passcode for the replay is 6214396. The audio recording of the call will also be available on the Company's website within 24 hours of the call.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/interpace-diagnostics-group-reports-fourth-quarter-and-full-year-2016-financial-results-business-progress-against-plan-and-recent-accomplishments-300431364.html
SOURCE IDXG
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