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Interpace Diagnostics Group, Inc. (NASDAQ: IDXG) Interpace Diagnostics Group, Inc. (NASDAQ: IDXG) is a fully integrated commercial company that provides clinically useful molecular diagnostic tests and pathology services. It was incorporated in 1986 and is headquartered in Parsippany, New Jersey. The Company currently has three commercialized molecular tests: PancraGEN®, ThyGenX®, and ThyraMIR®.

IDXG recently announced financial results and business progress for the quarter and full year ended December 31, 2016.

 

Revenue for the three- and twelve-month periods ended December 31, 2016 was $3.1 million and $13.1 million, respectively, an increase of 22% and 39% over the prior year periods. Net Income for the three- and twelve-month periods ended December 31, 2016 was $6.3 million and $(8.3) million, respectively, as against $4.4 million and $(11.4) for the same periods of the prior year.

2016 has proven to be a breakout year for IDXG, including strong revenue growth & significant cost reductions. From a balance sheet perspective, the company raised $14 million in gross equity and restructured over $9.3 million of secured debt, thereby partially improving its liquidity. The company’s liquidity has deteriorated in the past as negative profitability coincided with high payment obligations. However, recent restructuring is expected to lend substantial comfort to IDXG’s overall financial flexibility.

 

Over the last year, IDXG has transitioned into a fully integrated, commercially based molecular diagnostics entity. The company could have a strong base, as well as momentum into 2017, especially with its recent accomplishments, including New York State and AETNA approvals of ThyraMIR®, its microRNA assay, that is complementary to ThyGenX®.

 

To share more details on its present pipeline and outlook over the near to medium term, the company will be presenting at this year’s MicroCap Conference on April 4th in New York City. The company’s stock is on a modest growth path after these positive developments over the past few months based on its prospects.

 

About the Company:

 

IDXG 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.

 

Present Pipeline: The Company currently has three commercialized molecular tests:

 

 

• PancraGEN®, for the evaluation of pancreatic cysts and assessment of risk of subsequent cancer. 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.

 

• ThyGenX®, for the diagnosis of thyroid cancer from thyroid nodules. 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®, 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. 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.

 

Potential market:

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.

 

Recent announcements and momentum drivers:

• Announced that Aetna, the third largest health plan in the United States, has agreed to cover Interpace’s ThyraMIR test for all of Aetna’s 46 million members nationwide.  Interpace’s ThyGenX and ThyraMIR thyroid assays are now covered for approximately 200 million patients nationwide.
• Signed an agreement with America’s Choice Provider Network (ACPN), a national provider network with over 1,700 payers to provide coverage for all Interpace’s molecular tests including PancraGEN® for the diagnosis of pancreatic cancer from cysts and ThyGenX/ThyraMIR
• Announced Novitas approval to cover ThyraMir for microRNA gene expression in indeterminate biopsies for thyroid cancer.
• Signed an agreement with Galaxy Health Network, a national managed care provider with over 3.5 million covered lives, to provide coverage for all Interpace’s molecular pathology tests and services including PancraGEN, ThyraMir and ThyGenX.
• Announced that Geisinger Health Plan, which is part of one of the Nation’s largest and most innovative delivery systems in the US, has added ThyGenX and ThyraMir as covered services under their Medical Policy.

 

Proposed expansion plans:

 

• In September 2016, IDXG announced that New York State Department of Health approved ThyGenX, the Company’s Next Generation Sequencing oncogene panel for indeterminate thyroid nodules, allowing Interpace to offer both ThyGenX and ThyraMiR in New York State.
• Entered agreements with Lab Corp, a NYSE listed company, which provides leading-edge medical laboratory tests and services through a national network of primary clinical laboratories and specialty testing laboratories, to now co-market ThyraMIR along with ThyGenX.
• Announced the Company’s most recent entry in to expanding its commercial foot print internationally as a result of the adoption of the ThyGenX test by a Canadian key opinion leader in Montreal, Quebec. If successful, plans are already in place to expand in to other Provinces and work with the Canadian Health Ministry to secure coverage of both ThyGenX and ThyraMir.
• The Company completed its initial launch of PanDNA®, a new product that stratifies patients’ risk of developing pancreatic cancer based on three specific molecular criteria.  PanDNA was developed using the Company’s proprietary database of results for over 15,000 patients with pancreatic cysts.
• Entered in to an Agreement 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.  The Agreement designates Best Med as exclusive provider of Interpace’s products for the country of Israel.

 

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Key risk factors and potential stock drivers:

 

 

1. Company’s molecular diagnostics business has limited revenue, and the company is likely to incur net losses for the foreseeable future and may never achieve or sustain profitability.
2. The company’s liquidity continues to impinge its financial flexibility. Its ability to become a profitable operating company is dependent upon its ability to generate meaningful revenues and/or obtain financing adequate to support its cost structure.
3. IDXG does not currently have enough cash on hand to meet its obligations over the next twelve months, and the management cannot provide its stockholders any assurance that they will be able to raise sufficient funding from the generation of revenue, the sale of common stock, or through financing to sustain over the next twelve months.
4. Any inability to finance business on acceptable terms in the future may impair IDXG’s ability to develop and commercialize new molecular diagnostic solutions and technologies and grow business.

 

Earnings Review:

 

Revenue for three- and twelve-month periods ended December 31, 2016 was $3.1 million and $13.1 million, respectively, an increase of 22% and 39% over the prior year periods. This increase was principally attributable to increased test and collection volume of ThyGenX ® and ThyraMIR ®, and an increase in reimbursements, principally for ThyraMIR ® tests.

 

Profitability:

 

• Income (loss) from Continuing Operations for the three- and twelve-month periods ended December 31, 2016 was $6.3 million and $(8.4) million, respectively while (Loss) from Continuing Operations for the three- and twelve-month periods of the prior year was $(19.3) million and $(31.1) million, respectively.
• Net Income (Loss) for the three- and twelve-month periods ended December 31, 2016 was $6.3 million and $(8.3) million, respectively, and $4.4 million and $(11.4) for the same periods of the prior year.

 

Cash Flow & Balance Sheet:

 

• For fiscal year ended December 31, 2016, company had an operating loss of $6.4 million. As of December 31, 2016, it had cash and cash equivalents of $0.6 million and current liabilities of $16.2 million.

 

• It completed four public offerings and a private placement of warrants from December 22, 2016 through February 8, 2017, which resulted in aggregate gross proceeds to us of approximately $14.1 million.

 

• The proceeds from public offerings and private placement have improved its overall cash position temporarily. It may need to attempt to raise additional equity. However, the doubts raised, relating to its ability to continue as a going concern, may make investing in its securities a challenging investment for potential investors. These factors, among others, may make it difficult to raise any additional capital.

 

Stock Performance:

 

On Friday, March 31, 2017, IDXG shares declined by -10.85% to $2.6 on an average volume of 1.07 million shares exchanging hands. Market capitalization is $11.4 million. The current RSI is 56.54

 

In the past 52 weeks, shares of IDXG have traded as low as $0.70 and as high as $19.80.

 

At $2.6, shares of IDXG are trading below their 50-day moving average (MA) at $3.0 and below their 200-day MA at $3.2.

 

The present support and resistance levels for the stock are at $2.55 & $2.78 respectively.

 

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