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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Interpace Biosciences Inc | NASDAQ:IDXG | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 3.92 | 3.90 | 4.01 | 0 | 01:00:00 |
Revenue for the Quarter Grew 40% over the Comparable Prior Year Quarter and 21% for the Full Year, Raising $30 Million in Equity and Significantly Improving Balance Sheet and Cash Position, Reimbursement Continued to Grow Especially for ThyGenX® and ThyraMIR® Conference Call Thursday March 15, 2018 at 4:30 p.m. ET
“2017 definitively positioned IDXG as a force in the growing molecular diagnostics and bioinformatics sector as we delivered strong, sequential revenue growth, improved margins, and greatly improved liquidity during a period characterized by enhanced reimbursement and volume growth in our endocrine or (thyroid) franchise as well as growth in our gastrointestinal or (pancreas) franchise,” said Jack Stover, Interpace’s President and CEO. “During the year we raised approximately $30 million in capital and eliminated over $9 million of secured debt and royalties to further strengthen our balance sheet, providing the capital needed to keep us on a sustainable path during 2017 and 2018,” said Stover.
Q4 and 2017 Year End Financial Results and Performance
2017 and Recent Business Highlights
Reimbursement:
Commercial Expansion:
Clinical Evidence
Three posters supporting the clinical utility of PancraGEN® in assessing long-term risk of malignancy in pancreatic cystic lesions and three posters supporting the clinical utility of PancraGEN as an ancillary test for solid lesions of the pancreas and bile duct.
“Based on our accomplishments in 2017 and progress to date in scaling operations, gaining additional reimbursement and expanding our commercial activities, we are pleased with our performance in 2017 and we are looking forward to 2018,” concluded Stover.
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 PancraGEN
PancraGEN® is a molecular test that stratifies the risk of progression to pancreatic cancer from pancreatic cysts and solid masses by incorporating endoscopic ultrasound images, cytology, first-line chemistry testing like CEA and Amylase, and molecular markers into one of four risk categories ranging from Benign to Aggressive. 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.
About RespriDx
RespriDx™ is a molecular test that differentiates between new primary lung tumors and metastasis by identifying the unique molecular fingerprint of a tumor using a series of tumor markers and loss of heterozygosity (LOH). Discerning whether a lung neoplasm is the result of a newly formed tumor or metastasis is useful in determining what course of action physicians should take, e.g. surgery, chemotherapy, etc.
About Interpace Diagnostics Group, Inc.
Interpace is a fully integrated commercial and bioinformatics 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 four commercialized molecular tests and one test in a clinical evaluation process (CEP); PancraGEN® for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; ThyGenX® for the diagnosis of thyroid cancer from thyroid nodules utilizing a next generation sequencing assay; ThyraMIR® for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay; and RespriDX™ that differentiates lung cancer of primary vs. metastatic origin. BarreGEN® for Barrett's Esophagus, is currently being “soft launched” with key opinion leaders as we continue to gather data on this assay that will assist us in seeking favorable reimbursement as well as important clinical information. [Barrett's Esophagus is a rapidly growing diagnosis that affects over three million people in the US and over time can progress to esophageal cancer.] The Company’s data base includes data from over 45,000 patients who have been tested using the Company’s current products, including over 15,000 molecular tests for thyroid nodules. Interpace has been designated as one of the top 20 companies for providing bioinformatics solutions. Interpace’s mission is to provide personalized medicine through molecular diagnostics, innovation and data to advance patient care based on rigorous science. For more information, please visit Interpace’s website at www.interpacediagnostics.com
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, 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 history of losses, the Company's ability to adequately finance the business, 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 SEC filings, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2017 to be filed, Quarterly Reports on Form 10-Q and other SEC filings. 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 Group, Inc.Investor Relations:Paul Kuntz – Redchippaul@redchip.com
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, | |||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||
Revenue, net | $ | 4,370 | $ | 3,122 | $ | 15,897 | $ | 13,085 | ||||||||
Cost of revenue | 1,639 | 1,774 | 7,358 | 6,641 | ||||||||||||
Gross Profit | 2,731 | 1,348 | 8,539 | 6,444 | ||||||||||||
Sales and marketing | 2,060 | 1,276 | 6,567 | 5,462 | ||||||||||||
Research and development | 259 | 308 | 1,461 | 1,647 | ||||||||||||
General and administrative | 2,723 | 2,848 | 9,153 | 10,504 | ||||||||||||
Acquisition related amortization expense | 813 | 862 | 3,253 | 3,770 | ||||||||||||
Asset impairment | - | - | - | 3,363 | ||||||||||||
Change in fair value of contingent consideration | 174 | (10,686 | ) | (5,602 | ) | (11,860 | ) | |||||||||
Total operating expenses | 6,029 | (5,392 | ) | 14,832 | 12,886 | |||||||||||
Operating (loss) income | (3,298 | ) | 6,740 | (6,293 | ) | (6,442 | ) | |||||||||
Interest expense | - | (544 | ) | (433 | ) | (2,144 | ) | |||||||||
Loss on extinguishment of debt | - | - | (4,278 | ) | - | |||||||||||
Other (expense) income, net | (1,713 | ) | - | (2,128 | ) | 14 | ||||||||||
Loss from continuing operations before tax | (5,011 | ) | 6,196 | (13,132 | ) | (8,572 | ) | |||||||||
Income tax benefit | (55 | ) | (108 | ) | (395 | ) | (162 | ) | ||||||||
(Loss) income from continuing operations | (4,956 | ) | 6,304 | (12,737 | ) | (8,410 | ) | |||||||||
Discontinued Operations | ||||||||||||||||
Income (loss) from discontinued operations | 43 | 120 | 1,124 | (886 | ) | |||||||||||
Gain on sale of assets | - | - | - | 1,326 | ||||||||||||
Income from discontinued operations | 43 | 120 | 1,124 | 440 | ||||||||||||
Provision for income tax on discontinued operations | 94 | 143 | 603 | 362 | ||||||||||||
Income from discontinued operations, net of tax | $ | (51 | ) | $ | (23 | ) | $ | 521 | $ | 78 | ||||||
Net (loss) income | $ | (5,007 | ) | $ | 6,281 | $ | (12,216 | ) | $ | (8,332 | ) | |||||
Basic (loss) income per share of common stock: | ||||||||||||||||
From continuing operations | $ | (0.18 | ) | $ | 3.40 | $ | (0.81 | ) | $ | (4.63 | ) | |||||
From discontinued operations | (0.00 | ) | (0.01 | ) | 0.03 | 0.04 | ||||||||||
Net (loss) income per basic share of common stock | $ | (0.19 | ) | $ | 3.39 | $ | (0.77 | ) | $ | (4.59 | ) | |||||
Diluted (loss) income per share of common stock: | ||||||||||||||||
From continuing operations | $ | (0.18 | ) | $ | 3.25 | $ | (0.81 | ) | $ | (4.63 | ) | |||||
From discontinued operations | (0.00 | ) | (0.01 | ) | 0.03 | 0.04 | ||||||||||
Net (loss) income per diluted share of common stock | $ | (0.19 | ) | $ | 3.24 | $ | (0.77 | ) | $ | (4.59 | ) | |||||
Weighted average number of common shares and | ||||||||||||||||
common share equivalents outstanding: | ||||||||||||||||
Basic | 26,874 | 1,855 | 15,766 | 1,816 | ||||||||||||
Diluted | 26,874 | 1,941 | 15,766 | 1,816 | ||||||||||||
Selected Balance Sheet Data (Unaudited) | ||||||||||||||||
($ in thousands) | ||||||||||||||||
December 31, | December 31, | |||||||||||||||
2017 | 2016 | |||||||||||||||
Cash and cash equivalents | $ | 15,199 | $ | 602 | ||||||||||||
Total current assets | 19,808 | 4,240 | ||||||||||||||
Total current liabilities | 7,991 | 16,241 | ||||||||||||||
Total assets | 53,598 | 41,778 | ||||||||||||||
Total liabilities | 13,629 | 35,247 | ||||||||||||||
Total stockholders equity | 39,969 | 6,531 | ||||||||||||||
Selected Cash Flow Data (Unaudited) | ||||||||||||||||
($ in thousands) | ||||||||||||||||
For the Years Ended | ||||||||||||||||
December 31, | ||||||||||||||||
2017 | 2016 | |||||||||||||||
Net loss | $ | (12,216 | ) | $ | (8,332 | ) | ||||||||||
Net cash used in operations | $ | (15,263 | ) | $ | (7,607 | ) | ||||||||||
Net cash used in investing activities | (29 | ) | - | |||||||||||||
Net cash provided by (used in) financing activities | 29,889 | (101 | ) | |||||||||||||
Change in cash and cash equivalents | 14,597 | (7,708 | ) | |||||||||||||
Cash and equivalents, Beginning | 602 | 8,310 | ||||||||||||||
Cash and equivalents, Ending | $ | 15,199 | $ | 602 | ||||||||||||
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 both our contingent consideration and certain warrant liabilities. 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, | ||||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||||
(Loss) income from continuing operations | $ | (4,956 | ) | $ | 6,304 | $ | (12,737 | ) | $ | (8,410 | ) | ||||||
Depreciation and amortization- continuing operations | 876 | 992 | 3,690 | 4,292 | |||||||||||||
Stock-based compensation - continuing operations | 583 | 23 | 1,060 | 131 | |||||||||||||
Taxes | (55 | ) | (108 | ) | (395 | ) | (162 | ) | |||||||||
Interest expense | - | 544 | 433 | 2,144 | |||||||||||||
Mark to market on warrant liability | (260 | ) | - | 141 | - | ||||||||||||
Warrant expense | 2,016 | - | 2,016 | - | |||||||||||||
Asset impairment | - | - | - | 3,363 | |||||||||||||
Loss on extinguishment of debt | - | - | 4,278 | - | |||||||||||||
Change in fair value of contingent consideration | 174 | (10,686 | ) | (5,602 | ) | (11,860 | ) | ||||||||||
Adjusted EBITDA | $ | (1,622 | ) | $ | (2,931 | ) | $ | (7,116 | ) | $ | (10,502 | ) | |||||
Conference Call
As previously announced, Interpace will hold a conference call today Thursday, March 15, 2018 at 4:30 PM (ET) to discuss financial and operational results for the fourth quarter and the year ended December 31, 2017. Details as follows:
Time: 4:30 PM (ET)Dial-in numbers: toll free: 1-888-394-8218 (US) toll/international 1-323-701-0225 Conference ID#: 5146319
The live webcast and subsequent replay may be accessed by visiting Interpace’s website: www.interpacediagnostics.com. The webcast replay will be available on the company’s website within 24 hours following completion of the call and archived on the company’s website for 90 days.
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