UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 10-Q

 

 

 

(Mark One)

 

[X]QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2018March 31, 2019

 

OR

 

[  ]TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from _______________ to _______________

 

Commission File Number: 000-24249

 

Interpace Diagnostics Group, Inc.

(Exact name of registrant as specified in its charter)

Interpace Diagnostics Group, Inc.
(Exact name of registrant as specified in its charter)

 

Delaware 22-2919486
(State or other jurisdiction of
Incorporation or organization)
 (I.R.S. Employer
Identification No.)

 

Morris Corporate Center 1, Building C
300 Interpace Parkway, Parsippany, NJ 07054
(Address of principal executive offices and zip code)

(855) 776-6419
(Registrant’s telephone number, including area code)

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [  ]

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes [X] No [  ]

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,”filer”, “accelerated filer,”filer”, “smaller reporting company,”company” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer [  ]Accelerated filer [  ]
Non-accelerated filer [  ][X]Smaller reporting company [X]
  

(Do not check if a smaller

reporting company)

Emerging Growth Company [  ]

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [  ]

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes [  ] No [X]

 

Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered

Common Stock, $0.01 par value per share

IDXGThe Nasdaq Stock Market LLC

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date:

 

Class 

Shares Outstanding

August 3, 2018


May 10, 2019
 
Common stock,Stock, par value $0.01 par valueper share  28,194,27538,096,038 

 

 

 

 
 

 

INTERPACE DIAGNOSTICS GROUP, INC.

FORM 10-Q FOR PERIOD ENDED JUNE 30, 2018MARCH 31, 2019

TABLE OF CONTENTS

 

  Page No.
 PART I - FINANCIAL INFORMATION 
   
Item 1.Unaudited Interim Condensed Consolidated Financial Statements 
   
 Condensed Consolidated Balance Sheets at June 30, 2018March 31, 2019 (unaudited) and December 31, 201720183
   
 Condensed Consolidated Statements of Operations for the three- and six-monththree-month periods ended June 30,March 31, 2019 and 2018 and 2017 (unaudited)4
   
 Condensed Consolidated StatementStatements of Stockholders’ Equity for the six-month periodthree-month periods ended June 30,March 31, 2019 and 2018 (unaudited)5
   
 Condensed Consolidated Statements of Cash Flows for the six-monththree-month periods ended June 30,March 31, 2019 and 2018 and 2017 (unaudited)6
   
 Notes to Unaudited Interim Condensed Consolidated Financial Statements7
   
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations2221
   
Item 4.Controls and Procedures3428
   
 PART II - OTHER INFORMATION 
   
Item 1.Legal Proceedings3529
   
Item 1A.Risk Factors3529
   
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds3529
   
Item 6.Exhibits3529
   
Signatures3630

INTERPACE DIAGNOSTICS GROUP, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)

  June 30, 2018  December 31, 2017 
  (unaudited)    
       
ASSETS        
Current assets:        
Cash and cash equivalents $10,084  $15,199 
Accounts receivable, net  7,647   3,437 
Other current assets  1,474   1,172 
Total current assets  19,205   19,808 
Property and equipment, net  640   654 
Other intangible assets, net  31,480   33,105 
Other long-term assets  31   31 
Total assets $51,356  $53,598 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Current liabilities:        
Accounts payable $1,173  $391 
Accrued salaries and bonus  938   1,394 
Other accrued expenses  4,304   5,004 
Current liabilities from discontinued operations  939   1,302 
Total current liabilities  7,354   8,091 
Contingent consideration  1,111   1,349 
Other long-term liabilities  4,339   4,289 
Total liabilities  12,804   13,729 
         
Commitments and contingencies (Note 6)        
         
Stockholders’ equity:        
Preferred stock, $.01 par value; 5,000,000 shares authorized, no shares issued and outstanding  -   - 
Common stock, $.01 par value; 100,000,000 shares authorized; 28,267,344 and 27,900,806 shares issued, respectively; 28,194,275 and 27,836,456 shares outstanding, respectively  282   278 
Additional paid-in capital  174,360   173,062 
Accumulated deficit  (134,410)  (131,800)
Treasury stock, at cost (73,069 and 64,350 shares, respectively)  (1,680)  (1,671)
Total stockholders’ equity  38,552   39,869 
Total liabilities and stockholders’ equity $51,356  $53,598 

  March 31,  December 31, 
  2019  2018 
  (unaudited)    
       
ASSETS        
Current assets:        
Cash and cash equivalents $9,124  $6,068 
Accounts receivable, net  11,221   9,483 
Other current assets  1,888   2,170 
Total current assets  22,233   17,721 
Property and equipment, net  758   837 
Other intangible assets, net  29,040   29,853 
Operating lease assets  2,320   - 
Other long-term assets  31   31 
Total assets $54,382  $48,442 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Current liabilities:        
Accounts payable $1,152  $1,059 
Accrued salary and bonus  1,749   1,424 
Other accrued expenses  6,013   5,091 
Current liabilities from discontinued operations  918   918 
Total current liabilities  9,832   8,492 
Contingent consideration  2,627   2,693 
Operating lease liabilities  1,899   - 
Other long-term liabilities  4,253   4,319 
Total liabilities  18,611   15,504 
         
Commitments and contingencies (Note 7)        
         
Stockholders’ equity:        
Preferred stock, $.01 par value; 5,000,000 shares authorized, no shares issued and outstanding  -   - 
Common stock, $.01 par value; 100,000,000 shares authorized;

38,195,006 and 28,767,344 shares issued, respectively; 38,096,038 and 28,694,275 shares outstanding, respectively

  382   287 
Additional paid-in capital  181,954   175,820 
Accumulated deficit  (144,853)  (141,489)
Treasury stock, at cost (98,868 and 73,069 shares, respectively)  (1,712)  (1,680)
Total stockholders’ equity  35,771   32,938 
Total liabilities and stockholders’ equity $54,382  $48,442 

The accompanying notes are an integral part of these condensed consolidated financial statements.

INTERPACE DIAGNOSTICS GROUP, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited, in thousands, except for per share data)

  Three Months Ended March 31, 
  2019  2018 
       
Revenue, net $6,010  $4,809 
Cost of revenue (excluding amortization of $813 and $813, respectively)  2,622   2,580 
Gross profit  3,388   2,229 
Operating expenses:        
Sales and marketing  2,411   1,991 
Research and development  528   501 
General and administrative  2,912   2,172 
Acquisition related amortization expense  813   813 
Total operating expenses  6,664   5,477 
         
Operating loss  (3,276)  (3,248)
Accretion expense  (129)  - 
Other income (expense), net  48   111 
Loss from continuing operations before tax  (3,357)  (3,137)
Provision for income taxes  5   6 
Loss from continuing operations  (3,362)  (3,143)
         
Loss from discontinued operations, net of tax  (57)  (50)
         
Net loss $(3,419) $(3,193)
         
Basic and diluted loss per share of common stock:        
From continuing operations $(0.10) $(0.11)
From discontinued operations  (0.00)  (0.00)
Net loss per basic and diluted share of common stock $(0.10) $(0.11)
Weighted average number of common shares and common share equivalents outstanding:        
Basic  35,147   27,855 
Diluted  35,147   27,855 

The accompanying notes are an integral part of these condensed consolidated financial statements.

INTERPACE DIAGNOSTICS GROUP, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(unaudited, in thousands)

  For The Three Months Ended  For The Three Months Ended 
  March 31, 2019  March 31, 2018 
  Shares  Amount  Shares  Amount 
Common stock:                
Balance at January 1  28,767  $287   27,901  $278 
Common stock issued  95   1   41   1 
Common stock issued through offerings  9,333   94   -   - 
Balance at March 31  38,195   382   27,942   279 
Treasury stock:                
Balance at January 1  73   (1,680)  64   (1,671)
Treasury stock purchased  26   (32)  9   (9)
Balance at March 31  99   (1,712)  73   (1,680)
Additional paid-in capital:                
Balance at January 1      175,820       173,062 
Common stock issued through offerings, net of expenses      5,868       - 
Stock-based compensation expense      266       597 
Balance at March 31      181,954       173,659 
Accumulated deficit:                
Balance at January 1      (141,489)      (131,800)
Net loss      (3,419)      (3,193)
Adoption of ASC 606      -       2,500 
Adoption of ASC 842      55       - 
Balance at March 31      (144,853)      (132,493)
                 
Total stockholders’ equity     $35,771      $39,765 

The accompanying notes are an integral part of these condensed consolidated financial statements.

INTERPACE DIAGNOSTICS GROUP, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

  For The Three Months Ended March 31, 
  2019  2018 
       
Cash Flows From Operating Activities        
Net loss $(3,419) $(3,193)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization  873   855 
Interest accretion  129   - 
Mark to market on warrants  (3)  (71)
Stock-based compensation  538   597 
Other gains and expenses, net  18   - 
Other changes in operating assets and liabilities:        
Increase in accounts receivable  (1,738)  (466)
Decrease in other current assets  11   80 
Increase in accounts payable  93   344 
Increase (decrease) in accrued salaries and bonus  325   (397)
Increase (decrease) in accrued liabilities  156   (292)
Increase in long-term liabilities  57   49 
Net cash used in operating activities  (2,960)  (2,494)
         
Cash Flows From Investing Activity        
Purchase of property and equipment  (12)  (60)
Sale of property and equipment  13   - 
Net cash provided by (used in) investing activity  1   (60)
         
Cash Flows From Financing Activities        
Issuance of common stock, net of expenses  6,015   - 
Net cash provided by financing activities  6,015   - 
         
Net increase (decrease) in cash and cash equivalents  3,056   (2,554)
Cash and cash equivalents – beginning  6,068   15,199 
Cash and cash equivalents – ending $9,124  $12,645 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

36
 

INTERPACE DIAGNOSTICS GROUP, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited, in thousands, except for per share data)

  Three Months Ended  Six Months Ended 
  June 30,  June 30, 
  2018  2017  2018  2017 
             
Revenue, net $5,501  $3,855  $10,310  $7,325 
Cost of revenue (excluding amortization of $813 and $813 for the three months and $1,626 and $1,626 for the six months, respectively)  2,247   1,879   4,827   3,651 
Gross profit  3,254   1,976   5,483   3,674 
Operating expenses:                
Sales and marketing  2,095   1,555   4,086   2,691 
Research and development  518   413   1,019   719 
General and administrative  1,726   2,793   3,897   4,315 
Acquisition related amortization expense  813   813   1,626   1,626 
Change in fair value of contingent consideration  -   -   -   (5,776)
Total operating expenses  5,152   5,574   10,628   3,575 
                 
Operating (loss) income  (1,898)  (3,598)  (5,145)  99 
Interest expense  -   (216)  -   (469)
Loss on extinguishment of debt  -   (2,731)  -   (4,278)
Other income (expense), net  33   (8)  144   (44)
Loss from continuing operations before tax  (1,865)  (6,553)  (5,001)  (4,692)
Provision (benefit) for income taxes  8   (301)  14   (298)
Loss from continuing operations  (1,873)  (6,252)  (5,015)  (4,394)
(Loss) income from discontinued operations, net of tax  (44)  (54)  (95)  502 
Net loss $(1,917) $(6,306) $(5,110) $(3,892)
                 
Basic (loss) income per share of common stock:                
From continuing operations $(0.07) $(0.65) $(0.18) $(0.64)
From discontinued operations  (0.00)  (0.01)  (0.00)  0.07 
Net loss per basic share of common stock $(0.07) $(0.65) $(0.18) $(0.57)
                 
Diluted (loss) income per share of common stock:                
From continuing operations $(0.07) $(0.65) $(0.18) $(0.64)
From discontinued operations  (0.00)  (0.01)  (0.00)  0.07 
Net loss per diluted share of common stock $(0.07) $(0.65) $(0.18) $(0.57)
Weighted average number of common shares and common share equivalents outstanding:                
Basic  27,933   9,657   27,894   6,877 
Diluted  27,933   9,657   27,894   6,877 

The accompanying notes are an integral part of these condensed consolidated financial statements.

4
 

INTERPACE DIAGNOSTICS GROUP, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(unaudited, in thousands)

  For The Six Months Ended 
  June 30, 2018
  Shares  Amount 
Common stock:        
Balance at January 1  27,901  $278 
Common stock issued  366   4 
Balance at June 30  28,267   282 
Treasury stock:        
Balance at January 1  64   (1,671)
Treasury stock purchased  9   (9)
Balance at June 30  73   (1,680)
Additional paid-in capital:        
Balance at January 1      173,062 
Stock-based compensation expense      1,016 
Common stock issued      282 
Balance at June 30      174,360 
Accumulated deficit:        
Balance at January 1      (131,800)
Net loss      (5,110)
Adoption of ASC 606, see Note 3      2,500 
Balance at June 30      (134,410)
Total stockholders’ equity     $38,552 

The accompanying notes are an integral part of these condensed consolidated financial statements.

INTERPACE DIAGNOSTICS GROUP, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited, in thousands)

  Six Months Ended 
  June 30, 
  2018  2017 
       
Cash Flows Used in Operating Activities        
Net loss $(5,110) $(3,892)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization  1,710   1,937 
Interest accretion  1   271 
Provision for bad debt  -   25 
Amortization of debt issuance costs  -   117 
Mark to market on derivatives  -   61 
Reversal of severance accrual  -   (2,034)
Reversal of DOJ accrual  (350)  - 
Mark to market on warrants  (66)  76 
Loss on extinguishment of debt  -   4,278 
Stock-based compensation, consulting agreements  24   - 
Stock-based compensation  1,016   206 
Change in fair value of contingent consideration  -   (5,776)
Other changes in assets and liabilities:        
Increase  in accounts receivable  (1,710)  (512)
(Increase) decrease in other current assets  (40)  53 
Decrease in other long-term assets  -   220 
Increase (decrease) in accounts payable  782   (1,358)
Decrease in accrued salaries and bonus  (456)  (1,549)
Decrease in other accrued expenses  (944)  (789)
Increase in other long-term liabilities  116   94 
Net cash used in operating activities  (5,027)  (8,572)
         
Cash Flows Used in Investing Activities        
Purchase of property and equipment  (79)  - 
Net cash used in investing activities  (79)  - 
         
Cash Flows Used in Financing Activities        
Issuance of common stock, net of expenses  -   22,263 
Cash paid for repurchase of restricted shares  (9)  (28)
Net cash (used in) provided by financing activities  (9)  22,235 
         
Net (decrease) increase  in cash and cash equivalents  (5,115)  13,663 
Cash and cash equivalents – beginning  15,199   602 
Cash and cash equivalents – ending $10,084  $14,265 

The accompanying notes are an integral part of these condensed consolidated financial statements.

INTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Tabular information in thousands, except per share amounts)

 

1.BASIS OF PRESENTATION

 

The accompanying unaudited interim condensed consolidated financial statements and related notes (the “Interim Financial Statements”) should be read in conjunction with the consolidated financial statements of Interpace Diagnostics Group, Inc. (the “Company” or “Interpace”), and its wholly-owned subsidiaries, Interpace Diagnostics Lab Inc., Interpace Diagnostics Corporation and Interpace Diagnostics, LLC, and related notes as included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017,2018, as filed with the U.S. Securities and Exchange Commission (“SEC”) on March 23, 2018.21, 2019. The condensed Interim Financial Statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) for interim financial reporting and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. The condensed Interim Financial Statements include all normal recurring adjustments that, in the judgment of management, are necessary for a fair presentation of such interim financial statements. Discontinued operations include the Company’s wholly owned subsidiaries: Group DCA, LLC, (“or Group DCA”);DCA; InServe Support Solutions; and TVG, Inc. and its Commercial Services (“CSO”) business unit which was sold on December 22, 2015. All significant intercompany balances and transactions have been eliminated in consolidation. Operating results for the six-monththree-month period ended June 30, 2018March 31, 2019 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2018.2019.

 

2.LIQUIDITY

 

As of June 30, 2018,March 31, 2019, the Company had cash and cash equivalents of $10.1$9.1 million, net accounts receivable of $7.6$11.2 million, total current assets of $19.2$22.2 million and total current liabilities of $7.4$9.8 million. For the six monthsquarter ended June 30, 2018,March 31, 2019, the Company had a net loss of $5.1$3.4 million and cash used in operating activities was $5.0$3.0 million.

 

The Company does not expect to generate positive cash flows from operations for the year ending December 31, 2018.2019. The Company believes however, that it has sufficient cash balances to meet near term obligations and further intends to meet its capital needs by revenue growth, containing costs, entering into strategic alliances as well as exploring other options, including the possibility of raising additional debt or equity capital as necessary. There is, however, no assurance the Company will be successful in meeting its capital requirements prior to becoming cash flow positive.

 

In November 2018, the Company entered into up to a $4.0 million secured Line of Credit facility including a 3-year term loan for $850,000 with Silicon Valley Bank (“SVB”). The proceeds of the term loan are expected to be used for laboratory capital expenditures and will be repaid monthly. The term loan draw date will be on or before June 30, 2019. The $3.15 million balance of the Line of Credit is available for working capital purposes as a revolving line of credit and has a three-year term, ending November 2021. As of April 2, 2019, $0.25 million of this amount has been reserved, but not drawn, for a letter of credit related to the security deposit for our Pittsburgh facility lease. The borrowing limit of the revolving line of credit is the lower of 80% of the Company’s eligible accounts receivable (as adjusted by SVB) and the aggregate amount of cash collections with respect to accounts receivable during the three prior calendar months. Term loan outstanding amounts incur interest at a rate per annum equal to the greater of the Wall Street Journal Prime Rate (the “Prime Rate”) and 5.00%. Revolving Line outstanding amounts incur interest at a rate per annum equal to the Prime Rate plus 0.5%.

INTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Tabular information in thousands, except per share amounts)

3.SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Accounting Estimates

 

The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts of assets and liabilities reported and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Management’s estimates are based on historical experience, facts and circumstances available at the time, and various other assumptions that are believed to be reasonable under the circumstances. Significant estimates include accounting for valuation allowances related to deferred income taxes, contingent consideration, allowances for doubtful accounts, revenue recognition, unrecognized tax benefits, and asset impairments involving other intangible assets. The Company periodically reviews these matters and reflects changes in estimates in earnings as appropriate. Actual results could materially differ from those estimates.

INTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(Tabular information in thousands, except per share amounts)

 

Revenue Recognition

 

Our Services

 

We are a fully integrated commercial and bioinformatics company that develops and provides clinically useful molecular diagnostic tests and pathology services. We develop and commercialize molecular diagnosticgenomic tests and related first line assays principally focused on early detection of patients with indeterminate biopsies and at high risk of cancer and leverageusing the latest technology andto help personalized medicine for improvedand improve patient diagnosis and management. Our tests and services provide mutational analysis of genomic material contained in suspicious cysts, nodules and lesions with the goal of better informing treatment decisions in patients at risk of thyroid, pancreatic, and other cancers. The molecular diagnostic tests we offer enable healthcare providers to better assess cancer risk, helping to avoid unnecessary surgical treatment in patients at low risk. We currently have four commercialized molecular diagnostic assaystests in the marketplace for which we are receiving reimbursement: PancraGEN®, which is a pancreatic cyst and pancreaticobiliary solid lesion moleculargenomic test that helps physicians better assess risk of pancreaticobiliary cancers using our proprietary PathFinderTG®platform; ThyGenXThyGeNEXT®(now known as ThyGeNEXT™), which is an expanded oncogenic mutation panel that helps identify malignant thyroid nodules;nodules, and replaced ThyGenX®; ThyraMIR®, which assesses thyroid nodules for risk of malignancy utilizing a proprietary microRNA gene expression assay; and RespriDX™RespriDx®, launched in September 2017, for assessingwhich is a genomic test that helps physicians differentiate metastatic versusor recurrent lung cancer from the presence of newly formed primary lung cancer tumors. RespriDX™and which also utilizes our PathFinderTG® platform and comparesto compare the geneticgenomic fingerprint of two or more sites of lung cancer to determine whether the neoplastic deposits are representative of a recurrence of cancer or a new primary (independent) cancer. We are also “soft launching” BarreGEN®, an esophageal cancer risk classifier for Barrett’s Esophagus that also utilizes our PathFinder TG®platform. platform, is currently in a Clinical Evaluation Program or (“CEP”) whereby we gather information from physicians using BarreGEN® to assist us in positioning our product for full launch, partnering and potentially supporting reimbursement with payers.

 

Adoption of Accounting Standards Codification Topic 606 (“ASC 606”), “RevenueRevenue from Contracts with Customers”Customers (ASC 606)

 

Effective January 1, 2018, the Company adopted ASC 606 which amends the guidance for the recognition of revenue from contracts with customers for the transfer of goods and services, by using the modified-retrospective method applied to any contracts that were not completed as of January 1, 2018. The results for the reporting period beginning after January 1, 2018, are presented in accordance with the new standard, although comparative information has not been restated and continues to be reported under the accounting standards and policies in effect for those periods.

Upon adoption, the Company performed a comprehensive analysis of existing revenue arrangements as of January 1, 2018 following the five-step model outlined in ASC 606. Based on our analysis, we recorded a cumulative adjustment to opening accumulated deficit and increase of accounts receivable of $2.5 million as of January 1, 2018. The cumulative impact was driven by a change in the timing of revenue recognition for certain payer categories and the related proprietary tests performed. The balance of accounts receivable related to the adjustment is approximately $0.9 million as of June 30, 2018.

INTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(Tabular information in thousands, except per share amounts)

The following tables present the effect of the adoption of ASC Topic 606 on our condensed consolidated balance sheet and revenue as of and for the six months ended June 30, 2018:

Consolidated Balance Sheet:

  June 30, 2018 
     (unaudited)    
  As reported  Balances without Adoption of ASC 606  Effect of Change
Higher/(Lower)
 
Accounts receivable, net $7,647  $6,731  $916 
Accumulated deficit  (134,410)  (136,910)  (2,500)

Revenue:

  For the six months ended June 30, 2018 
     (unaudited)    
  As reported  Balances without Adoption of ASC 606  Effect of Change
Higher/(Lower)
 
Revenue, net $10,310  $9,580  $730 

Historically, for certain third-party payers that did not have established contractual reimbursement rates or a predictable pattern of collectability, including commercial insurance carriers, Medicaid and certain direct-bill payers (primarily hospitals, but also laboratories), the Company previously recognized revenues when the fee was fixed or determinable and collectability was reasonably assured, which was upon request of third-party payer notification of payment or when cash was received. Under the new standard, the Company estimates the variable consideration within the transaction price for all third-party payers and proprietary tests and recognizes revenue as the Company satisfies its performance obligations.

In addition, the Company updated its estimates of the expected transaction price and related reimbursement rates for its payer categories and related proprietary tests based on the variable consideration guidance in ASC 606. This consisted of updating the reimbursement rates realized by the Company’s proprietary tests based on historical amounts received by each payer category for the corresponding tests performed.

Overall, other than an initial acceleration in the timing of our revenue recognition for certain payer categories, the adoption of this new standard will not have a significant impact on our reported total revenues and operating results as compared to amounts that would have been reported under the prior revenue recognition standard over our typical revenue cycle. Our accounting policies under the new standard were applied prospectively and are discussed further below.

Revenue Recognition after adoption of ASC 606

Upon adoption of ASC 606, the Company recognizes revenue when a customer obtains control of promised goods or services in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price using the expected value method based on historical experience.

9

INTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(Tabular information in thousands, except per share amounts)

The Company derives its revenues from the performance of its proprietary tests. The Company’s performance obligation is fulfilled upon completion, review and release of test results to the customer. The Company subsequently bills third-party payers or direct-bill payers for the proprietary tests performed. Revenue is recognized based on the estimated transaction price or net realizable value (“NRV”), which is determined based on historical collection rates by each payer category for each proprietary test offered by the Company. To the extent the transaction price includes variable consideration, for all third party and direct-bill payers and proprietary tests, the Company estimates the amount of variable consideration that should be included in the transaction price using the expected value method based on historical experience.

The Company regularly reviews the ultimate amounts received from the third-party and direct-bill payers and related estimated reimbursement rates and adjusts the NRV’s and related contractual allowances accordingly. If actual collections and related NRV’s vary significantly from our estimates, we will adjust the estimates of contractual allowances, which would affect net revenue in the period such variances become known.

INTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Tabular information in thousands, except per share amounts)

 

Disaggregated Revenues

 

We operate in a single operating segment and, therefore, the results of our operations are reported on a consolidated basis for purposes of segment reporting, which is consistent with internal management reporting. For the six-monththree-month periods ended June 30,March 31, 2019 and 2018, and June 30, 2017, the majoritysubstantially all of the Company’s revenues were derived from its Gastrointestinal and Endocrine molecular diagnostic tests.

 

Financing and Payment

 

OurFor non-Medicare claims, our payment terms vary by payer category. Payment terms for direct-payers are typically thirty days. Commercial third-party-payers are required to respond to a claim within a time period established by their respective state regulations, generally between thirty to sixty days. However, payment for commercial third-party payersclaims may be subject to a denial and type of proprietary testing services performed.appeal process, which could take up to two years in some instances where multiple appeals are submitted. The term between invoicing and when payment is due is not significant.Company generally appeals all denials from commercial third-party payers.

 

Costs to Obtain or Fulfill a Customer Contract

 

Sales commissions are expensed when incurred because the amortization period would have been one year or less. These costs are recorded in sales and marketing expense in the condensed consolidated statements of operations.

 

Accounts Receivable

 

The Company’s accounts receivable represent unconditional rights to consideration and are generated using its proprietary molecular diagnostic tests. The Company’s services are fulfilled upon completion of the test, review and release of the test results. In conjunction with fulfilling these services, the Company bills the third-party payer or direct-bill payer. Prior todirectly bills the adoption of ASC 606 on January 1, 2018, the Company recognized accountshospital or service provider. Accounts receivable related to billings for Medicare, Medicare Advantage, and direct-bill payers on an accrual basis, net of contractual adjustment, when collectability was reasonably assured. Under ASC 606 accounts receivable is now recognized for all payer groups net of contractual adjustment and net of estimated uncollectable amounts. Contractual adjustments represent the difference between the list prices and the reimbursement ratesrate set by third party payers, including Medicare, commercial payers, andor amounts billed directly to direct-bill payers.hospitals and service providers. Specific accounts may be written off after several appeals, which in some cases may take longer than twelve months.

Leases

The Company determines if an arrangement contains a lease in whole or in part at the inception of the contract. Right-of-use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term while lease liabilities represent our obligation to make lease payments arising from the lease. All leases with terms greater than twelve months result in the recognition of a ROU asset and a liability at the lease commencement date based on the present value of the lease payments over the lease term. Unless a lease provides all of the information required to determine the implicit interest rate, we use our incremental borrowing rate based on the information available at the commencement date in determining the present value of the lease payments. We use the implicit interest rate in the lease when readily determinable.

Our lease terms include all non-cancelable periods and may include options to extend (or to not terminate) the lease when it is reasonably certain that we will exercise that option. Leases with terms of twelve months or less at the commencement date are expensed on a straight-line basis over the lease term and do not result in the recognition of an asset or liability.See Note 6, Leases.

INTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)(Continued)

(Tabular information in thousands, except per share amounts)

Other Current Assets

Other current assets consisted of the following as of June 30, 2018March 31, 2019 and December 31, 2017:2018:

 

  June 30, 2018  December 31, 2017 
  (unaudited)    
       
Indemnification asset $875  $875 
Prepaid assets  556   266 
Other  43   31 
  $1,474  $1,172 
  March 31, 2019  December 31, 2018 
   (unaudited)     
Indemnification assets $875  $875 
Prepaid expenses  941   1,230 
Other  72   65 
Total other current assets $1,888  $2,170 

 

Long-Lived Assets, including Finite-Lived Intangible Assets

 

Finite-lived intangible assets are stated at cost less accumulated amortization. Amortization of finite-lived acquired intangible assets is recognized on a straight-line basis, using the estimated useful lives of the assets of approximately two years to nine years in acquisition related amortization expense in the condensed consolidated statements of operations.

 

The Company reviews the recoverability of long-lived assets and finite-lived intangible assets whenever events or changes in circumstances indicate that the carrying value of such assets may not be recoverable. If the sum of the expected future undiscounted cash flows is less than the carrying amount of the asset, an impairment loss is recognized by reducing the recorded value of the asset to its fair value measured by future discounted cash flows. This analysis requires estimates of the amount and timing of projected cash flows and, where applicable, judgments associated with, among other factors, the appropriate discount rate. Such estimates are critical in determining whether any impairment charge should be recorded and the amount of such charge if an impairment loss is deemed to be necessary.

 

Discontinued Operations

 

The Company accounts for business dispositions and its businesses held for sale in accordance with ASC 205-20,Discontinued Operations (“ASC 205-20”). ASC 205-20 requires the results of operations of business dispositions to be segregated from continuing operations and reflected as discontinued operations in current and prior periods. See Note 11,12,Discontinued Operations for further information.

INTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(Tabular information in thousands, except per share amounts)

 

Basic and Diluted Net Loss per Share

A reconciliation of the number of shares of common stock used in the calculation of basic and diluted loss per share for the three- and six-monththree-month periods ended June 30,March 31, 2019 and 2018 and 2017 is as follows:

 

 Three Months Ended Six Months Ended 
 June 30, June 30,  Three Months Ended 
 2018 2017 2018 2017  March 31, 
 (unaudited)  2019 2018 
          (unaudited) 
Basic weighted average number of common shares  27,933   9,657   27,894   6,877   35,147   27,855 
Potential dilutive effect of stock-based awards  -   -   -   -   -   - 
Diluted weighted average number of common shares  27,933   9,657   27,894   6,877   35,147   27,855 

INTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Tabular information in thousands, except per share amounts)

 

The following outstanding stock-based instrumentsawards were excluded from the computation of the effect of dilutive securities on loss per share for the following periods because they would have been anti-dilutive:

 

  Three Months Ended  Six Months Ended 
  June 30,  June 30, 
  2018  2017  2018  2017 
  (unaudited) 
             
Options  2,256   323   2,256   323 
Stock-settled stock appreciation rights (SARs)  59   85   59   85 
Restricted stock units (RSUs)  220   68   220   68 
Warrants  13,542   17,105   13,542   17,105 
   16,077   17,581   16,077   17,581 

INTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(Tabular information in thousands, except per share amounts)

  Three Months Ended 
  March 31, 
  2019  2018 
  (unaudited) 
Options  3,936   2,256 
Stock-settled stock appreciation rights (SARs)  25   84 
Restricted stock units (RSUs)  607   220 
Warrants  14,196   13,542 
   18,764   16,102 

 

4.OTHER INTANGIBLE ASSETS

 

The net carrying value of the identifiable intangible assets as of June 30, 2018March 31, 2019 and December 31, 20172018 are as follows:

 

   As of June 30, 2018 As of December 31, 2017    As of
March 31, 2019
 As of
December 31, 2018
 
   (unaudited)      (unaudited)   
 Life Carrying Carrying  Life Carrying Carrying 
 (Years) Amount Amount  (Years) Amount Amount 
Diagnostic assets:                       
Asuragen acquisition:                       
Thyroid  9  $8,519  $8,519   9  $8,519  $8,519 
RedPath acquisition:                       
Pancreas test  7   16,141   16,141   7   16,141   16,141 
Barrett’s test  9   18,351   18,351   9   18,351   18,351 
Total    $43,011  $43,011      $43,011  $43,011 
Diagnostic lab:                       
CLIA Lab  2.3  $609  $609   2.3  $609  $609 
                       
Accumulated Amortization    $(12,140) $(10,515)     $(14,580) $(13,767)
                       
Net Carrying Value    $31,480  $33,105      $29,040  $29,853 

 

Amortization expense was approximately $0.8 million for the three-month periods ended June 30,March 31, 2019 and 2018, and 2017, respectively, and approximately $1.6 million for the six-month periods ended June 30, 2018 and 2017, respectively. Amortization of our diagnostic assets begins upon launch of the product. Estimated amortization expense for the next five years is as follows, based on current assumptions of future product launches:

 

2018 2019 2020 2021 2022 
20192019 2020 2021 2022 2023 
$3,252  $5,292  $5,292  $4,908  $2,987 3,252  $4,272  $4,908  $2,987  $2,987 

INTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Tabular information in thousands, except per share amounts)

 

5.FAIR VALUE MEASUREMENTS

 

Cash and cash equivalents, accounts receivable, and accounts payable approximate fair value due to their relative short-term nature. The Company’s financial liabilities reflected at fair value in the condensed consolidated financial statements include contingent consideration and warrant liability. Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. In determining fair value, the Company uses various methods including the market, income and cost approaches. Based on these approaches, the Company often utilizes certain assumptions that market participants would use in pricing the asset or liability, including assumptions about risk and/or the risks inherent in the inputs to the valuation technique. These inputs can be readily observable, market-corroborated, or generally unobservable inputs. The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs. Based upon observable inputs used in the valuation techniques, the Company is required to provide information according to the fair value hierarchy. The fair value hierarchy ranks the quality and reliability of the information used to determine fair values into three broad levels as follows:

 

Level 1:Valuations for assets and liabilities traded in active markets from readily available pricing sources for market transactions involving identical assets or liabilities.
  
Level 2:Valuations for assets and liabilities traded in less active dealer or broker markets. Valuations are obtained from third-party pricing services for identical or similar assets or liabilities.
  
Level 3:Valuations incorporate certain assumptions and projections in determining the fair value assigned to such assets or liabilities.

INTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(Tabular information in thousands, except per share amounts)

 

In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment, and considers factors specific to the asset or liability. The valuation methodologies used for the Company’s financial instruments measured on a recurring basis at fair value, including the general classification of such instruments pursuant to the valuation hierarchy, areis set forth in the tables below:

 

 As of June 30, 2018 Fair Value Measurements  As of March 31, 2019 Fair Value Measurements 
 Carrying Fair As of June 30, 2018  Carrying Fair As of March 31, 2019 
 Amount Value Level 1 Level 2 Level 3  Amount Value Level 1 Level 2 Level 3 
 (unaudited)  (unaudited) 
Liabilities:                                        
Contingent consideration:                                        
Asuragen(1) $1,427  $1,427  $-  $-  $1,427  $3,136  $3,136  $-  $-  $3,136 
Other long-term liabilities:                                        
Warrant liability(2)  407   407   -   -   407   358   358   -   -   358 
 $1,834  $1,834  $-  $-  $1,834  $3,494  $3,494  $-  $-  $3,494 

INTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Tabular information in thousands, except per share amounts)

 

 As of December 31, 2017 Fair Value Measurements  As of December 31, 2018 Fair Value Measurements 
 Carrying Fair As of December 31, 2017  Carrying Fair As of December 31, 2018 
 Amount Value Level 1 Level 2 Level 3  Amount Value Level 1 Level 2 Level 3 
Liabilities:                                        
Contingent consideration:                                        
Asuragen(1) $1,581  $1,581  $-  $-  $1,581  $3,127  $3,127  $-  $-  $3,127 
Other long-term liabilities:                                        
Warrant liability(2)  473   473   -   -   473   361   361   -   -   361 
 $2,054  $2,054  $-  $-  $2,054  $3,488  $3,488  $-  $-  $3,488 

 

(1)(2)See Note 7,8,Accrued Expenses and Long-Term Liabilities

 

In connection with the acquisition of certain assets from Asuragen, the Company recorded contingent consideration related to contingent payments and other revenue-based payments. The Company determined the fair value of the contingent consideration based on a probability-weighted income approach derived from revenue estimates. The fair value measurement is based on significant inputs not observable in the market and thus represents a Level 3 measurement.

 

On June 21, 2017, the Company closed onissued 575,000 Underwriters Warrants, related to a public offering issuing both Pre-Funded Warrants and Underwriters Warrants to purchase 2,600,000 shares and 575,000 shares ofon the Company’s common stock, respectively. Both the Pre-Funded and Underwriters Warrants includesame date that included a cash settlement feature in the event of certain circumstances. Accordingly, both the Pre-Funded and Underwriters Warrants are classified as liabilities and were fair valued using the Black Scholes Option-Pricing Model, the inputs for which includedinclude exercise price of the respective warrants, market price of the underlying common shares, expected term, volatility based on the Company’s historical market price, and the risk-free rate corresponding to the expected term of the underlying exchange agreement. Changes to the fair value of the warrant liabilities arewere recorded in Other income (expense), net. The Pre-Funded Warrants were fully exercised in 2017 and therefore the Company has no remaining liability associated with those warrants.

INTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(Tabular information in thousands, except per share amounts)

 

A roll forward of the carrying value of the Contingent consideration liabilityConsideration Liability and the Underwriters’ WarrantWarrants to June 30, 2018March 31, 2019 is as follows:

 

       Cancellation Mark to   
 December 31,     of Obligation/ Market June 30,        Cancellation Adjustment   
 2017 Payments Accretion Conversions Adjustment 2018        of Obligation/ to Fair Value/   
 (unaudited)  December 31, 2018 Payments Accretion Conversions Exercises Mark
to Market
 March 31, 2019 
              (unaudited) 
Asuragen $1,581  $(155) $1  $-  $-  $1,427  $3,127  $(120) $129  $-  $-  $3,136 
                                                
Underwriters Warrant  473   -       -   (66)  407 
Underwriters Warrants  361   -   -   -   (3)  358 
 $2,054  $(155) $1  $-  $(66) $1,834  $3,488  $(120) $129  $-  $(3) $3,494 

 

Certain of the Company’s non-financial assets, such as other intangible assets and goodwill, are re-measuredmeasured at fair value on a nonrecurring basis if and when there is an indicator of impairment and recorded at fair value only when an impairment charge is recognized.

INTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Tabular information in thousands, except per share amounts)

 

6.LEASES

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), which establishes a right-of-use model that requires a lessee to record a right-of-use asset and a lease liability, measured on a discounted basis, on the balance sheet for all leases with terms longer than 12 months. Effective January 1, 2019, the Company adopted the provisions of Topic 842 using the alternative modified transition method, with a cumulative effect adjustment to the opening balance of retained earnings on the date of adoption, and prior periods not restated, as allowed under the provisions of Topic 842. The Company also elected to use the practical expedients permitted under the transition guidance of Topic 842, which provides for the following: the carryforward of the Company’s historical lease classification, no requirement for reassessment of whether an expired or existing contract contains an embedded lease, no reassessment of initial direct costs for any leases that exist prior to the adoption of the new standard, and the election to consolidate lease and non-lease components. The Company also elected to keep all leases with an initial term of 12 months or less off the balance sheet.

The Company recorded $2.4 million of right-of-use lease assets and $2.5 million of lease liabilities upon adoption, primarily relating to rentals of space for our corporate headquarters and laboratories, as well as equipment leases, all under operating leases. In addition, the Company recorded a cumulative adjustment to opening accumulated deficit of $0.1 million.

The table below presents the lease-related assets and liabilities recorded in the Condensed Consolidated Balance Sheet:

  Classification on the Balance Sheet March 31, 2019 
     

(unaudited)

 
Assets      
Operating lease assets Operating lease assets $2,320 
Total lease assets   $2,320 
       
Liabilities      
Current      
Operating lease liabilities Other accrued expenses $526 
Noncurrent      
Operating lease liabilities Operating lease liabilities  1,899 
Total lease liabilities   $2,425 

The weighted average remaining lease term for the Company’s operating leases was 4.1 years as of March 31, 2019 and the weighted average discount rate for those leases was 6.0%. The Company’s operating lease expenses are recorded within cost of revenue and general and administrative expenses.

The table below reconciles the undiscounted cash flows to the operating lease liabilities recorded on the Company’s Condensed Consolidated Balance Sheet as of March 31, 2019:

  Operating Leases 
   

(unaudited)

 
2019 $495 
2020  675 
2021  671 
2022  629 
2023  250 
Total minimum lease payments  2,720 
Less: amount of lease payments representing effects of discounting  295 
Present value of future minimum lease payments  2,425 
Less: current obligations under leases  526 
Long-term lease obligations $1,899 

14

INTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Tabular information in thousands, except per share amounts)

As of December 31, 2018, contractual obligations with terms exceeding one year and estimated minimum future rental payments required by non-cancelable operating leases with initial or remaining lease terms exceeding one year were as follows:

     Less than  1 to 3  3 to 5  After 
  Total  1 Year  Years  Years  5 Years 
Operating lease obligations $2,814  $613  $1,322  $879  $- 
Contractual obligation  -   -   -   -   - 
Total $2,814  $613  $1,322  $879  $- 

7.COMMITMENTS AND CONTINGENCIES

 

Litigation

 

Due to the nature of the businesses in which the Company is engaged it is subject to certain risks. Such risks include, among others, risk of liability for personal injury or death to persons using products the Company promotes or commercializes. There can be no assurance that substantial claims or liabilities will not arise in the future due to the nature of the Company’s business activities and recent increases in litigation related to healthcare products.products and related intellectual property.

 

The Company could also be held liable for errors and omissions of its employees in connection with the services it performs that are outside the scope of any indemnity or insurance policy. The Company could be materially adversely affected if it were required to pay damages or incur defense costs in connection with a claim that is outside the scope of an indemnification agreement; if the indemnity, although applicable, is not performed in accordance with its terms; or if the Company’s liability exceeds the amount of applicable insurance or indemnity.

 

As of June 30, 2018,March 31, 2019, the Company’s accrual for litigation and threatened litigation was not material to the condensed consolidated financial statements.

15

INTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(Tabular information in thousands, except per share amounts)

RedPath – DOJ Settlement

In connection with the October 31, 2014 acquisition of RedPath Integrated Pathology, Inc., (“RedPath”), the Company assumed a liability for the settlement agreement entered into by the former owners of RedPath with the Department of Justice (“DOJ”). Under the terms of the settlement agreement, the Company was obligated to make payments to the DOJ for the calendar years ended December 31, 2014 through 2017, up to a maximum of $3.0 million. Payments were due on March 31st following the calendar year in which the revenue milestones were achieved. The Company made payments totaling $0.5 million during the year ended December 31, 2017 related to fiscal 2016 and had accrued $0.5 million for its potential liability for fiscal 2017, the final year of the settlement agreement. During the second quarter of 2018, the Company entered into an agreement with the DOJ to settle in full the outstanding fiscal 2017 liability at approximately $0.15 million and paid this amount as the final settlement payment in July 2018.

Prolias Technologies, Inc. v. PDI, Inc.

On April 8, 2015, Prolias Technologies, Inc. (“Prolias”) filed a complaint (the “Complaint”) against the Company with the Superior Court of New Jersey (Morris County) (the “Court”) in a matter entitled Prolias Technologies, Inc. v. PDI, Inc. In the Complaint, Prolias alleged that it and the Company entered into an August 19, 2013 collaboration agreement and an amendment thereto (collectively, the “Agreement”) whereby Prolias and the Company agreed to work in good faith to commercialize a diagnostic test known as “Thymira.” On March 9, 2017, the Court entered a final judgment in the Company’s favor against Prolias for the sum of $636,053 plus ten percent interest continuing to accrue on the principal balance of $500,000 unless and until paid. Final judgment was also entered in the Company’s favor and against Prolias, declaring Prolias is deemed to have executed and delivered to the Company a promissory note in the amount of $1,000,000 and Prolias is obligated to repay the Company the principal amount and all interest in accordance with the terms of the promissory note and the Agreement. On April 3, 2017, the final judgment against Prolias was recorded as a statewide lien. The Company has not recovered on the judgment against Prolias and no assurance can be given that the Company will ever be able to recover on the judgment in the future.

Pittsburgh Lease

On March 15, 2018, the Company amended the lease for its Pittsburgh laboratory to extend it through June 30, 2023. The lease is for 20,000 square feet of laboratory and office space, with monthly base rent of $33,333 beginning July 1, 2018, escalating by twenty-five percent (25%) on July 1, 2019 to $41,667 per month. The Company may, at its option, extend the term of the Lease for two consecutive terms of five years each, with the monthly base rent escalating by ten percent (10%) for each of the additional five year terms.

INTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(Tabular information in thousands, except per share amounts)

 

7.8.ACCRUED EXPENSES AND LONG-TERM LIABILITIES

 

Other accrued expenses consisted of the following as of June 30, 2018March 31, 2019 and December 31, 2017:2018:

 

  March 31, 2019  December 31, 2018 
   (unaudited)     
Accrued royalties $1,670  $1,399 
Indemnification liability  875   875 
Contingent consideration  510   434 
Accrued professional fees  648   701 
Operating lease liability  526   - 
Taxes payable  306   285 
Unclaimed property  565   565 
All others  913   832 
Total other accrued expenses $6,013  $5,091 

  June 30, 2018  December 31, 2017 
   (unaudited)     
         
Accrued royalties $573  $296 
Indemnification liability  875   875 
Contingent consideration  316   232 
DOJ settlement  150   500 
Accrued professional fees  690   700 
Taxes payable  471   515 
Unclaimed property  565   565 
All others  664   1,321 
  $4,304  $5,004 

Long-term liabilities consisted of the following as of June 30, 2018March 31, 2019 and December 31, 2017:2018:

 

  June 30, 2018  December 31, 2017 
  (unaudited)    
       
Warrant liability $407  $473 
Uncertain tax positions  3,838   3,734 
Other  94   82 
  $4,339  $4,289 

  March 31, 2019  December 31, 2018 
   (unaudited)     
Warrant liability $358  $361 
Uncertain tax positions  3,895   3,838 
Other  -   120 
Total other long-term liabilities $4,253  $4,319 

15

INTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Tabular information in thousands, except per share amounts)

 

8.9.STOCK-BASED COMPENSATION

Stock Incentive Plan

The Company’s stock-incentive program is a long-term retention program that is intended to attract, retain and provide incentives for talented employees, officers and directors, and to align stockholder and employee interests. Currently, the Company is able to grant options, SARs and restricted shares from the Interpace Diagnostics Group, Inc. Amended and Restated 2004 Stock Award and Incentive Plan, (the “Amended 2004 Plan”). Unless earlier terminated by action of its Board of Directors, the Amended 2004 Plan will remain in effect until such time as no stock remains available for delivery and the Company has no further rights or obligations under the Amended 2004 Plan with respect to outstanding awards thereunder.

 

Historically, stock options have been granted with an exercise price equal to the market value of the common stock on the date of grant, expire 10 years from the date they are granted, and generally vested over a one to three-year period for employees and members of the Board of Directors. Upon exercise, new shares will be issued by the Company. The Company granted stock options in 2017 which vest monthly over a one-year period. SARs are generally granted with a grant price equal to the market value of the common stock on the date of grant, vest one-third each year on the anniversary of the date of grant and expire five years from the date of grant. The restricted shares and restricted stock units granted to employees generally have a three-year graded vesting period and are subject to accelerated vesting and forfeiture under certain circumstances. Restricted shares and restricted stock units granted to board members generally have a three-year graded vesting period and are subject to accelerated vesting and forfeiture under certain circumstances.

INTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(Tabular information in thousands, except per share amounts)

 

During March 2018,2019, the Company’s Chief Executive Officer, Chief Financial Officer, seniorand other executives and members of the Board were granted incentive stock options to purchase an aggregate of 745,6001,105,440 shares of common stock with an exercise price of $1.01$0.98 per share and 186,400276,360 RSUs, (subjectsubject generally to the executive’s or board member’s, as applicable, continued service with the Company),Company, which vest one-third each year over a period of three years.

 

The following table provides the weighted average assumptions used in determining the fair value of the stock option awards granted during the six-monththree month periods ended June 30, 2018March 31, 2019 and 2017.2018.

 

 Six Months Ended 
 June 30, 2018 June 30, 2017 
 (unaudited)  March 31, 2019 March 31, 2018 
       (unaudited)   (unaudited) 
Risk-free interest rate  2.65%  1.96%  2.51%  2.65%
Expected life  6.00   4.91   6.0 years   6.0 years 
Expected volatility  126.93%  138.71%  127.81%  126.93%
Dividend yield  -   -   -   - 

 

The Company recognized approximately $0.4$0.5 million and $0.1$0.6 million of stock-based compensation expense during the three-month periods ended June 30, 2018 and 2017, respectively, and approximately $1.0 million and $0.2 million for the sixthree month periods ended June 30,March 31, 2019 and 2018, and 2017, respectively.

 

9.10.INCOME TAXES

 

Generally, accounting standards require companies to provide for income taxes each quarter based on their estimate of the effective tax rate for the full year. The authoritative guidance for accounting for income taxes allows use of the discrete method when it provides a better estimate of income tax expense. Due to the Company’s valuation allowance position, it is the Company’s position that the discrete method provides a more accurate estimate of income tax expense and therefore income tax expense for the current quarter has been presented using the discrete method. As the year progresses, the Company refines its estimate based on the facts and circumstances by each tax jurisdiction. The following table summarizes income tax expense on (loss) income from continuing operations and the effective tax rate for the three- and six-monththree-month periods ended June 30, 2018March 31, 2019 and 2017:

2018:

 

 Three Months Ended Six Months Ended  Three Months Ended 
 June 30, June 30,  March 31, 
 2018 2017 2018 2017  2019 2018 
 (unaudited) (unaudited)  (unaudited) 
              
Provision (benefit) from income tax $8  $(301) $14  $(298) $5  $6 
Effective income tax rate  (0.4)%  4.6%  (0.3)%  6.4%  (0.1%)  (0.2%)

 

Income tax expense for the three- and six-monththree-month periods ended June 30,March 31, 2019 and 2018 was primarily due to minimum state and local taxes.

16

INTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)(Continued)

(Tabular information in thousands, except per share amounts)

 

10.11.SEGMENT INFORMATION

 

Since December 22, 2015, the Company reports its operations as one segment, molecular diagnostics and bioinformatics. The Company’s reporting segment structure is reflective of the way both the Company’s management and chief operating decision maker view the business, make operating decisions and assess performance. This structure allows investors to better understand Company performance, better assess prospects for future cash flows, and make more informed decisions about the Company.

 

The Company’s molecular diagnostics and bioinformatics business focuses on developing and commercializing molecular diagnostic tests, leveraging the latest technology and personalized medicine for better patient diagnosis and management. Through the Company’s business, the Company aims to provide physicians and patients with diagnostic options for detecting genetic and other molecular alterations that are associated with gastrointestinal, endocrine and lung cancers, which are principally focused on early detection of patients at high risk of cancer. Customers in the Company’s segment consist primarily of physicians, hospitals and clinics. The service offerings throughout the segment have similar long-term average gross margins, contract terms, types of customers and regulatory environments. They are promoted through one centrally managed marketing group and the chief operating decision maker views their results on a combined basis.

 

11.12.DISCONTINUED OPERATIONS

 

The components of liabilities classified as discontinued operations relate to Commercial Services and consist of the following as of June 30, 2018March 31, 2019 and December 31, 2017:2018:

 

 June 30, 2018 December 31, 2017  March 31, 2019 December 31, 2018 
 (unaudited)    (unaudited)   
          
Accounts payable $192  $192  $192  $192 
Other  747   1,110   726   726 
Current liabilities from discontinued operations  939   1,302   918   918 
Total liabilities $939  $1,302  $918  $918 

 

12.13.LONG-TERM DEBTLINE OF CREDIT

 

As of March 31, 2019, the Company had no borrowings on its Silicon Valley Bank Loan and Security Agreement (“SVB Loan Agreement”) and was in compliance with all covenants. The SVB Loan Agreement provides for up to $4.0 million of debt financing and consists of a term loan (the “Term Loan”) of up to $850,000 and a revolving line of credit based on its outstanding accounts receivable (the “Revolving Line”) of up to $4.0 million. The Company intends to use the proceeds of the Term Loan for capital expenditures in connection with its laboratory expansion and the proceeds of the Revolving Line for working capital purposes. According to the Term Loan provisions, the Company intends to draw the full $850,000 by June 30, 2019.

As more fully describedINTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Tabular information in our Form 10-K filed onthousands, except per share amounts)

Term Loan outstanding amounts will bear interest at a rate per annum equal to the greater of the Wall Street Journal Prime Rate (the “Prime Rate”) and 5.00%. The amount that may be borrowed under the Revolving Line is the lower of (i) $4.0 million or (ii) 80% of the Company’s eligible accounts receivable (as adjusted by SVB) minus any outstanding amounts under the Term Loan. Revolving Line outstanding amounts incur interest at a rate per annum equal to the Prime Rate plus 0.5%. The Company is also required to pay an unused Revolving Line facility fee monthly in arrears in an amount equal to 0.35% per annum of the average unused but available portion of the Revolving Line.

14.SUPPLEMENTAL CASH FLOW INFORMATION

The following table represents cash flows used in the Company’s discontinued operations for the three months ended March 23, 2018, during the first six months31, 2019 and 2018:

  Three Months Ended 
  March 31, 
  2019  2018 
  (unaudited) 
         
Net cash used in operating activities of discontinued operations $-  $(315)

Supplemental Disclosures of fiscal 2017Non Cash Activities

(in thousands)

  Three Months Ended 
  March 31, 
  2019  2018 
  (unaudited) 
Operating        
Adoption of ASC 606 $-  $2,500 
Adoption of ASC 842 - right of use asset $2,449  $- 
Adoption of ASC 842 - operating lease liability $(2,536) $- 
Taxes accrued for repurchase of restricted shares $32  $- 
Investing        
Acquisition of property and equipment $-  $16 
Stock offering costs in other accrued expenses $53  $- 

15.EQUITY

On January 25, 2019, the Company entered into an Exchange Agreement relatedunderwriting agreement (the “Underwriting Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”) with respect to its debt withthe issuance and sale of an investor. The Company exchangedaggregate of 9,333,334 shares (the “RedPath Debt Exchange”“Firm Shares”) such then-existing debt for senior convertible notes (“Senior Convertible Notes”) of the Company on March 22, 2017. Subsequently between March 23, 2017 and April 18, 2017, the Senior Convertible Notes were converted into 3,795,429 shares of the Company’s common stock.stock, par value $0.01 per share (the “Common Stock”), in an underwritten public offering. Pursuant to the Underwriting Agreement, the Company also granted Wainwright an option, exercisable for 30 days, to purchase an additional 1,400,000 shares of Common Stock. The option expired unexercised. The Firm Shares were offered to the public at a price of $0.75 per Share. Wainwright purchased the Firm Shares from the Company recorded a losspursuant to the Underwriting Agreement at an effective price of $4.3 million$0.6975 per share.

INTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Tabular information in 2017 as a result of the exchange.thousands, except per share amounts)

 

The Company hasreceived net proceeds, after deducting underwriter discounts and commissions and other expenses related to the offering, in the amount of approximately $6.1 million. The Company intends to use the net proceeds from the offering for working capital, capital expenditures, business development and research and development expenditures, and acquisition of new technologies and businesses.

16.WARRANTS

In connection with the Wainwright underwritten public offering, the Company issued to Wainwright’s designees warrants (the “Underwriter Warrants”) to purchase up to 654,334 shares of Common Stock (representing 7% of the aggregate number of Firm Shares), at an exercise price of $0.9375 per share (representing 125% of the public offering price). The Underwriter Warrants are exercisable immediately and expire three years from the date of issuance.

There was no long-term debt.warrant exercise activity for the three months ended March 31, 2019. Warrants outstanding for the period ended March 31, 2019 are as follows:

Description Classification  Exercise Price  Expiration Date Warrants Issued  Warrants Exercised  Warrants Cancelled/ Expired  

Balance

December 31,2018

  Balance
March 31,2019
 
                        
Private  Placement Warrants, issued January 25, 2017 Equity    $4.69  June 2022  855,000   -   -   855,000   855,000 
RedPath Warrants,issued March 22, 2017 Equity    $4.69  September 2022  100,000   -   -   100,000   100,000 
Underwriters Warrants,issued June 21, 2017 Liability    $1.32  December 2022  575,000   -   (40,000)  535,000   535,000 
Base & Overallotment Warrants,issued June 21, 2017 Equity    $1.25  June 2022  14,375,000   (5,672,852)  -   8,702,148   8,702,148 
Vendor Warrants,issued August 6, 2017 Equity    $1.25  August 2020  150,000   -   -   150,000   150,000 
Warrants issued October 12, 2017 Equity    $1.80  April 2022  3,200,000   -   -   3,200,000   3,200,000 
Underwriters Warrants,issued January 25, 2019 Equity    $0.9375  January 2022  654,334   -   -   -   654,334 
                              
            19,909,334   (5,672,852)  (40,000)  13,542,148   14,196,482 

INTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(Tabular information in thousands, except per share amounts)

13.SUPPLEMENTAL CASH FLOW INFORMATION

The following table presents cash flows used in the Company’s discontinued operations for the six months ended June 30, 2018 and 2017:

  Six Months Ended 
  June 30, 
  2018  2017 
  (unaudited) 
Net cash used in operating activities of discontinued operations $(354) $(883)

Supplemental Cash Flow Information

(in thousands)

  Six Months Ended 
  June 30, 
  2018  2017 
  (unaudited) 
Operating        
Adoption of ASC 606 $2,500  $- 
Prepaid stock grants issued to vendors $286  $- 
         
Investing        
Acquisition of property and equipment in other accrued expenses $46  $- 
         
Financing        
Settlement of the RedPath Note $-  $(8,098)
Issuance of the Exchange Notes $-  $11,375 
Non-cash equity conversion costs $-  $(173)
Debt issuance costs $-  $(511)
Warrants issued through Termination Agreement* $-  $193 
Common shares issued in debt exchange $-  $8,869 

*See Note 14,Equity

14.EQUITY

As more fully described in our Form 10-K filed on March 23, 2018, during the first quarter of fiscal 2017 the Company issued 2,793,000 common shares and 855,000 warrants for gross proceeds amounting to $12.2 million. In addition, as described in Note 12,Long-Term Debt, the Company issued 3,795,429 common shares in connection with the RedPath Debt Exchange and conversion of Senior Convertible Notes. As part of the Debt Exchange, the Company entered into a Termination Agreement with RedPath Equityholder Representative, LLC, terminating milestone and royalty payments and issued 5 year warrants to acquire an aggregate of 100,000 shares of the Company’s common stock at a fixed price of $4.69 per share.

During the second quarter of 2017, the Company completed a public offering of (i) 9,900,000 shares of the Company’s common stock (the “Firm Shares”), (ii) warrants to purchase 12,500,000 shares of Common Stock at an exercise price equal to $1.25 per share (the “Base Warrants”) and (iii) warrants to purchase 2,600,000 shares of Common Stock at an exercise price equal to $0.01 per share (the “Pre-Funded Warrants”). Each Firm Share and accompanying Base Warrant was sold for a combined effective price of $1.10, and each Pre-Funded Warrant and accompanying Base Warrant was sold for a combined effective price of $1.09. The issuance of the Firm Shares and the Pre-Funded Warrants resulted in combined gross proceeds of the offering totaling $13.7 million, with approximately $12.3 million of net funds available to the Company after deducting underwriting discounts and other stock issuance expenses.

INTERPACE DIAGNOSTICS GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)(Continued)

(Tabular information in thousands, except per share amounts)

 

15.WARRANTS

There was no warrant activity for the six months ended June 30, 2018. Warrants outstanding for the period ended June 30, 2018 are as follows:

Description Classification Exercise Price  Expiration Date Warrants Issued  Warrants Exercised  Warrants Cancelled/ Expired  

Balance

December 31, 2017

  

Balance

June 30,

2018

 
                       
Private Placement Warrants, issued January 25, 2017 Equity $4.69  June 2022  855,000   -   -   855,000   855,000 
RedPath Warrants, issued March 22, 2017 Equity $4.69  September 2022  100,000   -   -   100,000   100,000 
Pre-Funded Warrants, issued June 21, 2017 Liability $0.01  None  2,600,000   (2,600,000)  -   -   - 
Underwriters Warrants, issued June 21, 2017 Liability $1.32  December 2022  575,000   -   (40,000)  535,000   535,000 
Base & Overallotment Warrants, issued June 21, 2017 Equity $1.25  June 2022  14,375,000   (5,672,852)  -   8,702,148   8,702,148 
Vendor Warrants, issued August 6, 2017 Equity $1.25  August 2020  150,000   -   -   150,000   150,000 
Warrants issued October 12, 2017 Equity $1.80  April 2022  3,200,000   -   -   3,200,000   3,200,000 
                             
           21,855,000   (8,272,852)  (40,000)  13,542,148   13,542,148 

16.17.RECENT ACCOUNTING PRONOUNCEMENTS

Recently adopted standards

 

In May 2014, the Financial Accounting Standards Board (“FASB”) issued ASU 2014-09, “Revenue from Contracts with Customers,” previously defined in Note 3 as “ASC 606”. The standard, including subsequently issued amendments, replaces most existing revenue recognition guidance in U.S. GAAP. The key focus of the new standard is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve this key focus, there is a five-step approach outlined in the standard. We adopted this new standard as of January 1, 2018, by using the modified-retrospective method. See Note 3,Summary of Significant Accounting Policies, for further details.

New standards not yet adopted

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), which when effective will require organizations that lease assets (e.g., through “leases”) to recognize assets and liabilities for the rights and obligations created by the leases on the balance sheet. A lessee will be required to recognize assets and liabilities for leases with terms that exceed twelve months. The standard will also require disclosures to help investors and financial statement users better understand the amount, timing and uncertainty of cash flows arising from leases. The disclosures include qualitative and quantitative requirements, providing additional information about the amounts recorded in the financial statements. The guidance is effective for public companies for annual reporting periods beginning after December 15, 2018, andincluding interim periods within those annual periods. Early adoption is permitted. The Company is currently evaluatingfiscal years. Topic 842 establishes a right-of-use model that requires a lessee to record a right-of-use asset and a lease liability, measured on a discounted basis, on the impactbalance sheet for all leases with terms longer than 12 months. Leases are to be classified as either finance or operating leases, with such classification affecting the pattern or expense recognition in the statement of operations. We adopted this new standard on its consolidated financial position and resultsas of operations.January 1, 2019, by using the alternative modified transition method. See Note 3,Significant Accounting Policies, for more details.

 

17.18.SUBSEQUENT EVENTSEVENT

 

Nasdaq Correspondence

On May 4, 2018,As previously disclosed on the Company wasCompany’s Current Report on Form 8-K, filed with the SEC on April 18, 2019, we were notified by NASDAQ on April 16, 2019 that we were no longer in compliance with the minimum bid price requirementsrequirement of NASDAQNASDAQ. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of at least $1.00 per share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for continueda period of thirty (30) consecutive business days. Based on the closing bid price of our common stock for the thirty (30) consecutive business days from March 5, 2019 to April 15, 2019, we no longer meet the minimum bid price requirement. The Notification Letter does not impact our listing and that we hadon The Nasdaq Capital Market at this time. We have 180 calendar days or until October 31, 201814, 2019 to regain compliance with this requirement or face delisting. On July 30, 2018 NASDAQ notifiedTo regain compliance, the Company that effective July 27, 2018bid price of our common stock must have a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days. We may be eligible for an additional 180 calendar day compliance period if we do not regain compliance by October 14, 2019. To qualify, we would be required to meet the Company was in compliancecontinued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the minimumexception of the bid price requirements of NASDAQrequirement, and the matter was determined to be closed.

Line of credit

Effective July 2018, the Company signed a letter of intent with Silicon Valley Bankwould need to provide upwritten notice of our intention to cure the deficiency during the second compliance period, by effecting a 3-year $4,000,000 linereverse stock split, if necessary. However, if it appears to the staff of credit based on 80%Nasdaq (the “Staff”) that we will not be able to cure the deficiency, or if we are otherwise not eligible, Nasdaq would notify us that our securities would be subject to delisting. In the event of netsuch a notification, we may appeal the Staff’s determination to delist its securities, but there can be no assurance the Staff would grant our request for continued listing. We are currently considering available receivables, including a term portion of $850,000options to support capital expansions.regain compliance.

 

2120
 

 

INTERPACE DIAGNOSTICS GROUP, INC.

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

FORWARD-LOOKING STATEMENTS

 

This quarterly report on Form 10-Q (“Form 10-Q”)(Form 10-Q) contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Statements that are not historical facts, including statements about our plans, objectives, beliefs and expectations, are forward-looking statements. Forward-looking statements include statements preceded by, followed by or that include the words “believes,” “expects,” “anticipates,” “plans,” “estimates,” “intends,” “projects,” “should,” “could,” “may,” “will” or similar words and expressions. These forward-looking statements are contained throughout this Form 10-Q.

 

Forward-looking statements are only predictions and are not guarantees of future performance. These statements are based on current expectations and assumptions 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 our control. These predictions are also affected by known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from those expressed or implied by any forward-looking statement. Many of these factors are beyond our ability to control or predict. Our actual results could differ materially from the results contemplated by these forward-looking statements due to a number of factors. Such factors include, but are not limited to, the following:

 

the limited revenue generated from our business thus far and our ability to commercially leverage our bioinformatics data and develop our pipeline products;
our obligations to make royalty and milestone payments to our licensors;
our inability to finance our business on acceptable terms in the future may limit our ability to develop and commercialize new molecular diagnostic solutions and technologies and grow our business;
 our ability to profitably growcomply with financial covenants under our business, includingcurrent line of credit facility and comply with our ability to finance our business on acceptable terms and successfully compete in the market;debt obligations;
 whether we are able to successfully utilize our commercial and operating experience to sell our molecular diagnostic tests;
our products continuing to perform as expected;
our limited operating history;
our ability to attract and retain key personnel;
our dependence on a concentrated selection of third-party payers including the lack of timeliness of their payments;
 our ability to obtain broad adoption of and ability to grow or continue to secure sufficient levels of reimbursement for our molecular diagnostic tests in a changing reimbursement environment;
whether we are ableenvironment, including obtaining clinical data to successfully utilize our operating experience to sell our molecular diagnostic tests;
our limited operating history as a molecular diagnostics company;
our dependence on a concentrated selectionsupport sufficient levels of payers for our molecular diagnostic tests;
reimbursement;
 the demand for our molecular diagnostic tests from physicians and patients;
 our relationships with leading thought leaders and biopharmaceutical companies;
demonstration of clinical relevance and value in utility studies;
our ability to continue to expand our sales and marketing forces;
 our reliance on our internalcommercial sales forces for continued business expansion;
 fluctuating quarterly operating results;
 our dependence on third parties for the supply of some of the materials used in our molecular diagnostic tests;
 our ability to scale our operations, testing capacity and processing technology;
 our ability to support demand for our molecular diagnostic tests and any of our future tests or solutions;
 our ability to compete successfully with physicians and members of the medical community who use traditional methods to diagnose gastrointestinal and endocrine cancers, competitors offering broader product lines outside of the molecular diagnostic testing market and having greater brand recognition than we do, and companies with greater financial resources;
 our ability to obtain sufficient data and samples to cost effectively and timely perform sufficient clinical trials in order to support our current and future products;
 
product liability claims against us;
patent infringement claims against us;
our ability to license rights to use technologies in order to commercialize new products;
 our involvement in current and future litigation against us or our ability to collect on judgements found in our favor;
our ability to continuously develop our technology and to work to develop new solutions to keep pace with evolving standards of care;
 our ability to enter into additional clinical study collaborations with highly regarded institutions;

INTERPACE DIAGNOSTICS GROUP, INC.

 

the effect of seasonal results and adverse weather conditions, such as hurricanes and floods, on our business;
 the effect current and future laws, licensing requirements and regulation have on our business including the changing U.S. Food and Drug Administration, or the FDA, environment as it relates to molecular diagnosis;
 
the effect of potential adverse findings resulting from regulatory audits of our billing practices and the impact such results could have on our business;
our exposure to environmental liabilities as a result of our business;
the susceptibility of our information systems to security breaches, loss of data and other disruptions;
our ability to enter into effective electronic data interchange arrangements with our customers and third-party payers;
��
our billing practices and our ability to collect on claims for the sale of our molecular diagnostic tests;
our dependence on a third-party medical billing provider to operate effectively without delays, data loss, or other disruptions;
our ability to attract and retain qualified sales representatives and other key employees and management personnel;
competition in the segment of the molecular diagnostics industry in which we operate or expect to operate;
our ability to obtain additional funding when necessary, in order to implement our business models and strategies;
the results of any future impairment testing for other intangible assets;
our ability to successfully identify, complete and integrate any future acquisitions and the effects of any such items on our revenues, profitability and ongoing business;
our compliance with our license agreements and our ability to protect and defend our intellectual property rights;
our ability to maintain our listing with The Nasdaq Capital Market (“NASDAQ”);
the effect of adverse weather conditions, such as hurricanes and floods, on our business;
failure of third-party service providers to perform their obligations to us;
the volatility of our stock price and fluctuations in our quarterly and annual revenues and earnings;
our ability to obtain and maintain sufficient laboratory space to meet our processing needs as well as our ability to pass regulatory inspections and continue to be Clinical Laboratory Improvement Amendments (“CLIA”) and the College of American Pathologists (“CAP”) certified CLIA laboratories and be CAP certified;or accredited;
 legislative reform of the U.S. healthcare system, including the effect of pricing provisions of the Protecting Access to Medicare Act of 2014 (“PAMA”) on our Advanced Diagnostic Laboratory Tests (ADLTs), adjustments or reductions in reimbursement rates of our molecular diagnostic tests by the Center for Medicare and Medicaid Services (“CMS”) and changes or reductions in reimbursement rates or coverage of our tests by third party payers;
compliance with numerous statutes and regulations pertaining to our business;
the effect of potential adverse findings resulting from regulatory audits of our billing and payment practices and the impact such results could have on our business;
business, regulatory, political, operational, financial, and economic risks associated with doing business outside of the United States, including our ability to comply with international laws and regulations;
compliance with the FCPA and anti-bribery laws;
tax reform legislation;
changes in financial accounting standards or practices;
our use of hazardous materials;
the susceptibility of our information systems to security breaches, loss of data and other disruptions;
product liability claims against us;
 our ability to commercially leverage our bioinformatics data with pharmaceuticalattract and retain qualified commercial representatives and other potential partnerskey employees and management personnel;
our billing practices and our ability to collect on claims for the sale of our tests;
our dependence on third-party medical billing providers to operate effectively without delays, data loss, or other disruptions;
cost increases resulting from enacted healthcare reform legislation;
changes in newgovernmental regulations mandating price controls and limitations on patient access to our products;
our ability to increase revenue lines;and manage the size of our operations;

INTERPACE DIAGNOSTICS GROUP, INC.

our ability to successfully identify, complete and integrate any future acquisitions of companies and/or products that we believe meet our strategic goals and needs, and the effects of any such acquisitions on our revenues, profitability and ongoing business;
our ability, and the ability of our third-party billing providers, to effectively maintain, upgrade and integrate the information systems on which we depend, including our partially customized Laboratory Information Management System (LIMS);
 the ability to obtain or maintain supportive “guidelines” from trade and/or therapeutic related organizations focused on the clinical efficacy and utilityresults of molecular diagnostics in our areas of focus; and
any future impairment testing for intangible assets as required under GAAP;
 determination thatthe impact of contingent liabilities on our Advanced Diagnostic Laboratory Tests (ADLTs) have become affected by the pricing provisions of the Processing Access to Medicare Act of 2014 (“PAMA”) which could result in an across the board reduction in our reimbursement rates; and
financial condition;
 Ourour compliance with our license agreements and our ability to continueprotect and defend our intellectual property rights;
changes in U.S. patent law;
patent infringement claims against us;
our ability to developmaintain our listing with The Nasdaq Capital Market (“NASDAQ”);
compliance with public company reporting requirements;
the impact of future issuances of debt, common and support preferred shares on stockholders’ interest and stock price;
our partially customized Laboratory Information System(LIMS), which isability to report financial results on a timely and accurate basis;
the impact of anti-takeover defenses on an acquisition or stock price;
the volatility of our automated basisstock price and fluctuations in our quarterly and annual revenues and earnings;
publications, or the lack thereof, by equity research analysts about us, our business and our competitors;
securities class action litigation;
cost of managing operations, storing datasettlement or damage awards against our directors and customer information.officers; and
the effect of The Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”) as it potentially impacts our ability to incentive our sales personnel appropriately.

 

Please see Part I – Item 1A – “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2017,2018, filed March 23, 2018,21, 2019, as well as other documents we file with the U.S. Securities and Exchange Commission (“SEC”) from time-to-time, for other important factors that could cause our actual results to differ materially from our current expectations as expressed in the forward-looking statements discussed in this Form 10-Q. Because of these and other risks, uncertainties and assumptions, you should not place undue reliance on these forward-looking statements. In addition, these statements speak only as of the date of the report in which they are set forth and, except as may be required by law, we undertake no obligation to revise or update publicly any forward-looking statements for any reason.

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INTERPACE DIAGNOSTICS GROUP, INC.

 

Company OverviewOVERVIEW

 

We are a fully integrated commercial and bioinformatics company that develops and provides clinically useful molecular diagnostic tests and pathology services. We develop and commercialize molecular diagnosticgenomic tests and related first line assays principally focused on early detection of patients with indeterminate biopsies and at high risk of cancer and leverageusing the latest technology andto help personalized medicine for improvedand improve patient diagnosis and management. Our tests and services provide mutational analysis of geneticgenomic material contained in suspectsuspicious cysts, nodules and lesions that helps physicians risk-stratifywith the goal of better informing treatment decisions in patients at risk of thyroid, pancreatic, and other cancers to better inform treatment decisions.cancers. The molecular diagnostic tests we offer enable healthcare providers to better assess cancer risk, helping to avoid unnecessary surgeries and better assess the risk of cancer progressionsurgical treatment in their patients.patients at low risk. We currently have four commercialized molecular diagnostic assaystests in the marketplace for which we are receiving reimbursement: PancraGEN®, which is a pancreatic cyst and pancreaticobiliary solid lesion moleculargenomic test that helps physicians better assess risk of pancreaticobiliary cancers using our proprietary PathFinderTG®platform; ThyGenXThyGeNEXT® (now ThyGeNEXT™), which is an expanded oncogenic mutation panel that helps identify malignant thyroid nodules;nodules and replaced ThyGenX®; ThyraMIR®, which assessassesses thyroid nodules for risk of malignancy utilizing a proprietary microRNA gene expression assay. We also launched in September 2017 RespriDX ™,assay; and RespriDx®, which is a moleculargenomic test that helps physicians differentiate metastatic or recurrent lung cancer from the presence of a newly formed primary lung cancer. RespriDX™cancer and which also utilizes our PathFinderTG® platform to compare the genomic fingerprint of two or more sites of lung cancer. We are also in the process of “soft launching” while we gather additional market data, BarreGenBarreGEN®, an esophageal cancer risk classifier for Barrett’s Esophagus that also utilizes our PathFinderTGPathFinder TG® platform.platform, is currently in a Clinical Evaluation Program or (“CEP”) whereby we gather information from physicians using BarreGEN® to assist us in positioning our product for full launch, partnering and potentially supporting reimbursement with payers.

 

Our mission is to provide personalized medicine through moleculargenomics-based diagnostics and innovation to advance patient care based on rigorous science. Our laboratories are licensed pursuant to federal law under the Clinical Laboratory Improvement Amendments (“CLIA”)CLIA and are accredited by the College of American Pathologists (“CAP”)CAP and New York State (“NYS”). State. In August 2018, we acquired a majority of the Philadelphia laboratory equipment of Rosetta Genomics Ltd., a molecular diagnostics company, in order to further support our CLIA and CAP certified lab expansion in our New Haven, Connecticut and Pittsburgh, Pennsylvania laboratories.

We are leveraging our licensed and accredited laboratories to develop and commercialize our assays and products. We aim to provide physicians and patients with diagnostic options for detecting genomic and other molecular alterations that are associated with gastrointestinal, endocrine, and lung cancers. Our customers consist primarily of physicians, hospitals and clinics.

 

The global molecular diagnostics market is estimated to be approximately $6.5 billion and is a segment within the approximately $60 billion in vitro diagnostics market according to statistics from Kalorama Information, publisher oftheWorldwide Market for In Vitro Diagnostic Tests. We believe that the molecular diagnostics market offers significant growth and strong patient value given the substantial opportunity it affords to lower healthcare costs by helping to reduce unnecessary surgeries and ensuring the appropriate frequency of monitoring. We are keenly focused on growing our test volumes, securing additional insurance coverage and reimbursement, maintaining and growing our current reimbursement and supporting revenue growth for our four commercialized innovativemolecular diagnostic tests, introducing related first line product and service extensions, as well as expanding our business by developing and promoting synergistic products in our markets. We also believe that BarreGen®BarreGen® is a potentially importantsignificant pipeline product, also built on the PathFinderTG®platform, whichand we are providing necessary resources to accelerate our development process. Further, we believe BarreGEN®is synergistic towith our capabilities and potentially is a significant product opportunity in the gastrointestinal market, which is one of the sectors in which we operate. Additionally, we are focused on either acquiring or licensing products that either leverage our commercial capabilities and/or diversify our revenue base away from the risks associated with reimbursement by leveraging our molecular data and capabilities.

 

Additional Reimbursement Coverage and Network Availability During 2018 (to-date)2019

 

Reimbursement progress is key for any molecular diagnostic company. We have been successful to date in 2018 expanding the reimbursement of our products.products in 2019. Specifically, the most significant progress we have made regarding payers to date in 20182019 is as follows:

 

 In February 2018, we announced that Horizon Blue Cross Blue Shield of New Jersey, the oldest and largest health plan in New Jersey, covering 3.8 million patients living in the Northeastern United States, has agreed to cover ThyGenX® (now ThyGeNEXT™) and ThyraMIR®for its members effective January 9, 2018.

In March 2018, we announced coverage of ThyGenX®(now ThyGeNEXT™) and ThyraMIR®by four new Blue Cross Blue Shield Plans: Blue Cross Blue Shield of Arizona, Blue Cross Blue Shield of South Carolina, Wellmark Blue Cross Blue Shield of Iowa, and Wellmark Blue Cross Blue Shield of South Dakota. These four plans combined represent over 5 million members.

INTERPACE DIAGNOSTICS GROUP, INC.

In March 2018 we announced that we had entered into a laboratory services agreement with Acupath Laboratories, Inc. based in Plainview, New York (Long Island) whereby Acupath’s Commercial team will be selling ThyGenX® (now ThyGeNEXT™) and ThyraMIR® as part of its menu for endocrinologists, endocrine surgeons, and other physicians focused on the diagnosis and treatment of thyroid cancer.
In April 2018,2019, we announced that we had entered into an Agreement with BJC Healthcarethe University of St. Louis, Missouri,Maryland Medical System (“UMMS”) to provide physicians’ access to ThyGeNEXT®, ThyraMIR®, and PancraGEN®across the UMMS network, which includes 4,000 affiliated physicians who provide primary and specialty care in more than 150 locations and at 14 hospitals.

INTERPACE DIAGNOSTICS GROUP, INC.

In April 2019, we announced that Medica, one of the largest non-profit, integrated healthcare systemshealth plans in the United States. The Agreement enables all physicians across the BJC system access toMidwest, extended coverage of both ThyGenXThyGeNEXT® (now ThyGeNEXT™) and ThyraMIR® for patients with indeterminateto its 1.3 million covered lives. Physicians across Medica’s entire network will now be able to utilize Interpace’s thyroid nodules.products.
 In May 2018,April 2019, we announced that we had entered into an agreement with Vanderbilt University Medical Center (VUMC) based in Nashville, TN, one of the largest academic medical centers in the country. The agreement enables all physicians across the Vanderbilt system accessreceived approval to both ThyGenX® (now ThyGeNEXT™) andlaunch ThyraMIR® for patients with indeterminatediagnostic testing on formalin-fixed, paraffin-embedded (“FFPE”) tissue samples from thyroid nodules.
In May 2018, we announced that 14 Blue Cross Blue Shield plans acrossnodules from the country have published favorable coverage policies since the beginning of 2018 for ThyGenX® (now ThyGeNEXT™) and ThyraMIR®, the Company’s molecular tests for indeterminate thyroid nodules. The list of plans includes many of the largest Blue Cross Blue Shield plans in the country, including Blue Shield of California and Horizon Blue Cross Blue ShieldState of New Jersey, previously announced by us. As a result of these 14 new policies, over 75 million members participating in these plans now have coverage for ThyGenX® (now ThyGeNEXT™) and ThyraMIR® testing.
In June 2018, we announced coverage of ThyGenX® (now ThyGeNEXT™) and ThyraMIR® by Blue Cross Blue Shield of Florida, the largest health plan in Florida with over three million members. As of July 2018 there are twenty-seven regional Blue Cross Blue Shield regional payers, who have agreed to provide coverage for ThyGenX® (now ThyGeNEXT™) and ThyraMIR®.
In July 2018, we announced that we expanded the application of PancraGEN® beyond pancreatic cysts to include both biliary strictures and solid pancreatic lesions while gaining further Guideline support in the marketplace. PancraGEN® is the first and only commercially available integrated molecular pathology test for pancreaticobiliary cancers.
In July 2018, we also announced that CIGNA, one of the nation’s largest health plan providers, has agreed to cover ThyraMIR®, the first microRNA gene expression classifier for thyroid nodules, as medically necessary. This is in addition to its coverage of ThyGenX®, (now ThyGeNEXT™) as previously announced in 2017.York.

INTERPACE DIAGNOSTICS GROUP, INC.

 

DESCRIPTION OF REPORTING SEGMENTS

 

Since December 22, 2015, the Company reports its operations as one segment, molecular diagnostics and bioinformatics. The Company’s reporting segment structure is reflective of the way both the Company’s management and chief operating decision maker view the business, make operating decisions and assess performance. We believe thisThis structure allows investors to better understand Company performance, better assess prospects for future cash flows, and make more informed decisions about the Company.

 

Revenue

 

The Company’s revenue is generated from the performance of its proprietary molecular diagnostics tests. The Company’s performance obligation is fulfilled upon completion, review and release of test results and subsequent billing to the third-party payer hospital or service provider.

Revenue Recognition Prior to the Adoption of ASC 606hospital.

 

Historically, for the time periods through December 2017, the Company recognized revenue from services rendered when the following four revenue recognition criteria were met: persuasive evidence of an arrangement exists; services have been rendered; the selling price is fixed or determinable; and collectability is reasonably assured. The Company recognized revenue related to billings for Medicare, Medicare Advantage, and direct-bill payers on an accrual basis, net of contractual adjustment, when there was a predictable pattern of collectability. Contractual adjustments represent the difference between the list prices and the reimbursement rate set by Medicare and Medicare Advantage, or the amounts billed to direct-bill payers, which approximates the Medicare rate. For certain third-party payers that did not have established contractual reimbursement rates or a predictable pattern of collectability, including commercial insurance carriers and Medicaid, the Company believed that the fee was fixed or determinable and collectability was reasonably assured only upon request of third-party payer notification of payment or when cash is received, and recognized revenue at that time.

Until a contract had been negotiated with a commercial insurance carrier or governmental program, the services may or may not be covered by these entities’ existing reimbursement policies. In the absence of an agreement with the patient or other clearly enforceable legal right to demand payment, the related revenue was only recognized upon the earlier of payment notification or cash receipt. Accordingly, we recognized revenue from commercial insurance carriers, government programs, and certain direct-bill healthcare providers without contracts when payment was received.

Revenue Recognition after the Adoption of ASC 606

Beginning January 1, 2018 underUnder ASC 606, the Company began to recognizerecognizes revenue for billings less contractual allowances and estimated uncollectable amounts for all payer groups on the accrual basis based upon a thorough analysis of historical receipts. The net amount derived and used for revenue recognition is referred to as the “net realizable value” or (“NRV”) for the particular test and payer group from which reimbursement is received. This derived NRV will beis evaluated quarterly or as needed and then applied to future periods until recalculated.

 

The Company completed its analysisPersuasive evidence of an arrangement exists and delivery is deemed to have occurred upon completion, review, and release of the ASC 606 impact and incorporated further analysistest results at which time we billed the third-party payor or hospital. The assessment of first quarter 2018 collections from its commercial payer base in finalizing its ASC 606 adjustments. The impactthe fixed or determinable nature of recording the cumulative catch-up adjustment under the modified retrospective method was $2.5 million, recorded as an increase to opening retained earnings on January 1, 2018. Prior periods have not been retrospectively adjusted. The Company also finalized its analysis of modified internal controls over financial reportingfees charged for diagnostic testing performed, and the disclosures required startingcollectability of those fees, requires significant judgment by our management. Our management believes that these two criteria have been met when there is contracted reimbursement coverage or a predictable pattern of collectability with Form 10-Q forindividual third-party payers or hospitals and accordingly, recognized revenue upon delivery of the first quartertest results. In the absence of 2018.

INTERPACE DIAGNOSTICS GROUP, INC.

Costcontracted reimbursement coverage or a predictable pattern of servicescollectability, we believe that the fee was fixed or determinable and collectability was reasonably assured only upon request of third-party payor notification of payment or when cash was received, and we recognize revenue at that time.

 

Cost of services consists primarily of the costs associated with operating our laboratories and other costs directly related to our tests. Personnel costs, which constitute the largest portion of cost of services, include all labor related costs, such as salaries, bonuses, fringe benefits and payroll taxes for laboratory personnel. Other direct costs include, but are not limited to, laboratory supplies, certain consulting expenses, and facility expenses.

 

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INTERPACE DIAGNOSTICS GROUP, INC.

CONDENSED CONSOLIDATED RESULTS OF OPERATIONS

 

The following table sets forth, for the periods indicated, certain statements of operations data. The trends illustrated in this table may not be indicative of future results.

 

Condensed Consolidated Results of Continuing Operations for the Quarter Ended June 30, 2018March 31, 2019 Compared to the Quarter Ended June 30, 2017March 31, 2018 (in thousands)

 

  Three Months Ended March 31, 
  2019  2019  2018  2018 
             
Revenue, net $6,010   100.0% $4,809   100.0%
Cost of revenue  2,622   43.6%  2,580   53.6%
Gross profit  3,388   56.4%  2,229   46.4%
Operating expenses:                
Sales and marketing  2,411   40.1%  1,991   41.4%
Research and development  528   8.8%  501   10.4%
General and administrative  2,912   48.5%  2,172   45.2%
Acquisition related amortization expense  813   13.5%  813   16.9%
Total operating expenses  6,664   110.9%  5,477   113.9%
                 
Operating loss  (3,276)  -54.5%  (3,248)  -67.5%
Accretion expense  (129)  -2.1%  -   0.0%
Other income (expense), net  48   0.8%  111   2.3%
Loss from continuing operations before tax  (3,357)  -55.9%  (3,137)  -65.2%
Provision for income taxes  5   0.1%  6   0.1%
Loss from continuing operations  (3,362)  -55.9%  (3,143)  -65.4%
                 
Loss from discontinued operations, net of tax  (57)  -0.9%  (50)  -1.0%
                 
Net loss $(3,419)  -56.9% $(3,193)  -66.4%

  Three Months Ended 
  June 30, 
  2018  2018  2017  2017 
             
Revenue, net $5,501   100.0% $3,855   100.0%
Cost of revenue  2,247   40.8%  1,879   48.7%
Gross profit  3,254   59.2%  1,976   51.3%
Operating expenses:                
Sales and marketing  2,095   38.1%  1,555   40.3%
Research and development  518   9.4%  413   10.7%
General and administrative  1,726   31.4%  2,793   72.5%
Acquisition related amortization expense  813   14.8%  813   21.1%
Total operating expenses  5,152   93.7%  5,574   144.6%
                 
Operating loss  (1,898)  -34.5%  (3,598)  -93.3%
Interest expense  -   0.0%  (216)  -5.6%
Loss on extinguishment of debt  -   0.0%  (2,731)  -70.8%
Other income (expense), net  33   0.6%  (8)  -0.2%
Loss from continuing operations before tax  (1,865)  -33.9%  (6,553)  -170.0%
Provision (benefit) for income tax  8   0.1%  (301)  -7.8%
Loss from continuing operations  (1,873)  -34.0%  (6,252)  -162.2%
Loss from discontinued operations, net of tax  (44)  -0.8%  (54)  -1.4%
Net loss $(1,917)  -34.8% $(6,306)  -163.6%

28

INTERPACE DIAGNOSTICS GROUP, INC.

Revenue, net

 

Consolidated revenue, net for the three months ended June 30, 2018March 31, 2019 increased by $1.6$1.2 million, or 42.7%25%, to $5.5$6.0 million, compared to $3.9$4.8 million for the three months ended June 30, 2017.March 31, 2018. This increase was principally attributable to increased test volume and commercial coverage for our thyroid tests and the change in revenue recognition under ASC 606 from cash basis to accrual of approximately $0.3 million for certain payer groups, as disclosed in the footnotes to the financial statements.

tests.

 

Cost of revenue

 

Consolidated cost of revenue for the three months ended June 30,March 31, 2019 and March 31, 2018 increased by $0.4 million, or 19.6%. As a percentage of revenue cost of revenue decreased to 40.8% as compared to 48.7%were comparable in the comparable prior year period. The decrease as a percentage of revenue can be attributed to efficiencies in the manufacturing process relative to higher test volumes as well as the timing of purchases.both periods at approximately $2.6 million.

Gross profit

 

Consolidated gross profit for the three months ended June 30, 2018March 31, 2019 increased $1.3$1.2 million, or 64.7%52%, to $3.3$3.4 million, as compared to $2.0$2.2 million for the three months ended June 30, 2017. This increase was primarily relatedMarch 31, 2018. The gross profit percentage increased from 46% for the first quarter of 2018 to 56% for the first quarter of 2019 due to the increase inleveraging of fixed costs over the higher revenue and improved laboratory cost efficiencies related to higher test volumes,base as discussed above.well as the timing of lab supply purchases for the quarter ended March 31, 2018.

 

Sales and marketing expense

 

Sales and marketing expense was $2.1$2.4 million for the three months ended June 30, 2018 andMarch 31, 2019, or 40% as a percentage of revenue was 38.1%.net revenue. For the three months ended June 30, 2017,March 31, 2018, sales and marketing expense was $1.6$2.0 million, and 40.3%or 41% as a percentage of net revenue. The increase in sales and marketing expense principallyprimarily reflects an increase in employee and consulting costs of $0.4 million, as we are expanding the size of our salesforce costs as well as increasedand increasing our marketing spending.activities which are supporting our growth.

 

25

INTERPACE DIAGNOSTICS GROUP, INC.

Research and development

 

Research and development expense reflects clinicaltotaled approximately $0.5 million for both the three months ended March 31, 2019 and research costs for supplies, laboratory tests and evaluations, scientific and administrative staff involved in clinical research, statisticalMarch 31, 2018. As a percentage of revenue research and product development relatedexpense decreased to new tests, products and programs. These costs were approximately $0.5 million9% for the three months ended June 30, 2018 and approximately $0.4 millionMarch 31, 2019 as compared to 10% for the three months ended June 30, 2017. AsMarch 31, 2018. This decrease as a percentage of revenue they were 9.4% forwas due to the three months ended June 30, 2018 and 10.7% for the three months ended June 30, 2017.increase in revenue discussed above.

 

General and administrative

 

General and administrative expense for the three months ended June 30, 2018March 31, 2019 was $1.7$2.9 million as compared to $2.8$2.2 million for the three months ended June 30, 2017. The decreaseMarch 31, 2018. This increase was primarily attributable to a net decreaseincreases in the Department of Justice (“DOJ”) accrual expenseprofessional fees of approximately $0.5$0.4 million in connection with evaluating strategic initiatives and non-cash compensation for professional services of $0.3 million in warrant issuance costs and $0.2 million in rent and moving expenses that occurred inwhen compared to the second quarter of 2017, with no similar cost in fiscalended March 31, 2018.

29

INTERPACE DIAGNOSTICS GROUP, INC.

 

Acquisition related amortization expense

 

During both the three months ended June 30,March 31, 2019 and March 31, 2018, and June 30, 2017, we recorded amortization expense of approximately $0.8 million, respectively in connectionboth periods which is related to intangible assets associated with the RedPath and Asuragen acquired intangible assets.prior acquisitions.

 

Operating loss

 

We experienced operating losses of $1.9Operating loss from continuing operations was $3.3 million for the three months ended June 30, 2018 and $3.6March 31, 2019 as compared to $3.2 million for the three months ended June 30, 2017.March 31, 2018. The decreaseincrease can be attributed to the increase in the operating lossgeneral and administrative expense discussed above.

Provision for income taxes

The Company’s income tax expense was approximately $5,000 for the three months ended June 30, 2018 was primarily attributable to the increase in revenueMarch 31, 2019 and gross profit and the decrease in G&A expenses discussed above.

Provision (benefit) for income taxes

We had income tax expense of approximately $8,000$6,000 for the three months ended June 30, 2018 and an income tax benefit of approximately $0.3 million for the three months ended June 30, 2017.March 31, 2018. Income tax expense for 2018both periods was primarily due to requireddriven by minimum state and local taxes. The income tax benefit for 2017 was primarily due to allocation of tax expense between continuing and discontinued operations.

 

Loss(Loss) income from discontinued operations, net of tax

 

We had a loss from discontinued operations of approximately $44,000$0.06 million for the three months ended June 30, 2018March 31, 2019 and a loss from discontinued operations of $0.1$0.05 million for the three months ended June 30, 2017. The loss from discontinued operations for both periods was primarily related to the allocation of income tax expense.

INTERPACE DIAGNOSTICS GROUP, INC.

Condensed Consolidated Results of Continuing Operations for the Six Months Ended June 30, 2018 Compared to the Six Months Ended June 30, 2017 (in thousands)

  Six Months Ended 
  June 30, 
  2018  2018  2017  2017 
             
Revenue, net $10,310   100.0% $7,325   100.0%
Cost of revenue  4,827   46.8%  3,651   49.8%
Gross profit  5,483   53.2%  3,674   50.2%
Operating expenses:                
Sales and marketing  4,086   39.6%  2,691   36.7%
Research and development  1,019   9.9%  719   9.8%
General and administrative  3,897   37.8%  4,315   58.9%
Acquisition related amortization expense  1,626   15.8%  1,626   22.2%
Change in fair value of contingent consideration  -   0.0%  (5,776)  -78.9%
Total operating expenses  10,628   103.1%  3,575   48.8%
                 
Operating (loss) income  (5,145)  -49.9%  99   1.4%
Interest expense  -   0.0%  (469)  -6.4%
Loss on extinguishment of debt  -   0.0%  (4,278)  -58.4%
Other income (expense), net  144   1.4%  (44)  -0.6%
Loss from continuing operations before tax  (5,001)  -48.5%  (4,692)  -64.1%
Provision (benefit) for income tax  14   0.1%  (298)  -4.1%
Loss from continuing operations  (5,015)  -48.6%  (4,394)  -60.0%
(Loss) income from discontinued operations, net of tax  (95)  -0.9%  502   6.9%
Net loss $(5,110)  -49.6% $(3,892)  -53.1%

Revenue, net

Consolidated revenue for the six months ended June 30, 2018 increased by $3.0 million, or 40.8%, to $10.3 million, compared to $7.3 million for the six months ended June 30, 2017.

This increase was principally attributable to increased test volume and commercial coverage for our thyroid tests and the change in revenue recognition under ASC 606 from cash basis to accrual of approximately $0.7 million for certain payer groups, as disclosed in the footnotes to the financial statements.

Cost of revenue

Consolidated cost of revenue for the six months ended June 30, 2018 increased by $1.2 million or 32.2% as compared to the same period in 2017. The primary reason for the increase was the increase in test volumes over the prior year. As a percentage of revenue, cost of revenue decreased to 46.8% as compared to 49.8% in the comparable prior year period due primarily to laboratory cost efficiencies relative to the increase in test volume and related revenues.

Gross profit

Gross profit, as a percentage of revenue, increased to 53.2% for the six months ended June 30, 2018 as compared to 50.2% for the six months ended June 30, 2017. This increase was also primarily due to laboratory cost efficiencies relative to the increase in test volume and related revenues.

INTERPACE DIAGNOSTICS GROUP, INC.

Sales and marketing expense

Sales and marketing expenses were $4.1 million for the six months ended June 30, 2018, and as a percentage of revenue was 39.6%. For the six months ended June 30, 2017, sales and marketing expenses were $2.7 million and 36.7% as a percentage of revenue. The increase in sales and marketing expense principally reflect an increase in salesforce costs as well as increased marketing spending.

Research and development

Research and development costs totaled $1.0 million for the six months ended June 30, 2018 and as a percentage of revenue were 9.9%. For the six months ended June 30, 2017 the expense was $0.7 million and as a percentage of revenue was 9.8%. The increase in research and development expenses was primarily due to an increase in certain costs that are internally allocated to Research and Development, as well as an increase in employee stock compensation costs affiliated with research and development personnel.

General and administrative

General and administrative expense for the six months ended June 30, 2018 was $3.9 million as compared to $4.3 million for the six months ended June 30, 2017. This decrease was primarily attributable to a comparable reduction in DOJ settlement expense totaling $1.1 million, partially offset by an increase in employee expenses of $0.6 million in the current year.

Acquisition related amortization expense

During both the six months ended June 30, 2018 and June 30, 2017, we recorded amortization expense of approximately $1.6 million.

Change in fair value of contingent consideration

During the six months ended June 30, 2017, there was a $5.8 million reduction in the contingent consideration liability as the result of the termination of the contingent consideration agreement with Redpath Equity Holders Representative, LLC, for amounts associated with future royalty payments for the assets acquired from Redpath, as disclosed in Note 14,Equity of the footnotes to the financial statements.

Operating (loss) income

We experienced an operating loss of $5.1 million for the six months ended June 30, 2018, and operating income of $0.1 million during the six months ended June 30, 2017. The operating income for the six months ended June 30, 2017 was primarily attributable to the reversal of our RedPath contingent consideration liability of $5.8 million. Without the reversal of contingent consideration, the operating income from continuing operations for the six months ended June 30, 2017 would have been an operating loss of $5.7 million.

INTERPACE DIAGNOSTICS GROUP, INC.

Provision (benefit) for income taxes

We had income tax expense of approximately $14,000 for the six months ended June 30, 2018 and an income tax benefit of approximately $0.3 million for the six months ended June 30, 2017. The income tax benefit for 2017 was primarily due to allocation of tax expense between continuing and discontinued operations.

(Loss) income from discontinued operations, net of tax

We had a loss from discontinued operations of $0.1 million for the six months ended June 30, 2018 and income from discontinued operations of $0.5 million for the six months ended June 30, 2017. The income from discontinued operations for the six months ended June 30, 2017 was primarily related to reversals of severance accruals.March 31, 2018.

 

LIQUIDITY AND CAPITAL RESOURCES

 

For the sixthree months ended June 30, 2018,March 31, 2019, we had an operating loss of $5.1$3.3 million. As of June 30, 2018,March 31, 2019, we had cash and cash equivalents of $10.1$9.1 million, net accounts receivable of $11.2 million, total current assets of $19.2$22.2 million and current liabilities of $7.4$9.8 million.

During the three months ended March 31, 2019, net cash used in operating activities was $3.0 million, all of which was used in continuing operations. The main component of cash used in operating activities during the three months ended March 31, 2019 was the net loss of $3.4 million. During the three months ended March 31, 2018, net cash used in operating activities was $2.5 million, of which $2.2 million was used in continuing operations and $0.3 million was used in discontinued operations. The main component of cash used in operating activities during the three months ended March 31, 2018 was the net loss of $3.2 million.

INTERPACE DIAGNOSTICS GROUP, INC.

Our accounts receivable increased to $11.0 million from $6.4 million at the end of Q1 of 2018, principally due to our growing revenues and partially due to the impact of the adoption of ASC 606. We began recognizing all of our revenue on an accrual basis effective January 1, 2018. Prior to that date, revenue from certain payer groups was being recognized on a cash basis. Therefore as of March 31, 2019, we have been using the full accrual basis for 15 months, as compared to only 3 months as of March 31, 2018. Additionally we changed our billing and collections contractor and we are still in the process of finalizing transition.

For the three months ended March 31, 2019, there was cash provided from financing activities of $6.0 million which resulted from the issuance of common stock in our underwritten public offering completed in January 2019.

 

We intend to meet our capital needs by driving revenue growth, containing costs as well as exploring other options, includingoptions. Management believes that the possibility of raising additional debt or equity capital as necessary.Company has sufficient cash on hand to sustain operations through at least May 31, 2020. There is however, no guarantee that additional capital can be raised to fund our future operations.

 

During the six months ended June 30, 2018, net cash used in operating activities was $5.0 million, of which $4.6 million was used in continuing operations and $0.4 million was used in discontinued operations. The main component of cash used in operating activities during the six months ended June 30, 2018 was the net loss of $5.1 million. During the six months ended June 30, 2017, net cash used in operating activities was $8.6 million, of which $7.7 million was used in continuing operations and $0.9 million was used in discontinued operations. The main component of cash used in operating activities during the six months ended June 30, 2017 was a net loss of $3.9 million, a decrease in accrued payroll of $1.5 million and accounts payable of $1.4 million related to past due obligations from the prior year. For the six months ended June 30, 2018, there was $0.1 million of net cash used in investing activities for the purchase of lab and computer equipment. There was no cash used in investing activities for the six months ended June 30, 2017.

For the six months ended June 30, 2017, there was net cash provided from financing activities of $22.2 million, which resulted from the issuance of common stock in our four direct offerings completed in the first six months of 2017.

Inflation

 

We do not believe that inflation had a significant impact on our results of operations for the periods presented. On an ongoing basis, we attempt to minimize any effects of inflation on our operating results by controlling operating costs and whenever possible, seeking to insure that billing rates reflect increases in costs due to inflation.

 

Off-Balance Sheet Arrangements

 

None.

 

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INTERPACE DIAGNOSTICS GROUP, INC.

Item 3. — Quantitative and Qualitative Disclosures About Market Risk.

As a smaller reporting company, we are electing scaled disclosure reporting obligations and therefore are not required to provide the information requested by this Item.

 

Item 4. Controls and Procedures

 

Evaluation of disclosure controls and procedures

 

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures pursuant to Rule 13a-15 under the Exchange Act as of the end of the period covered by this Form 10-Q. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives including that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In addition, management is required to apply its judgment in evaluating the benefits of possible disclosure controls and procedures relative to their costs to implement and maintain.

 

Based on the evaluation of the Company’s disclosure controls and procedures, as that term is defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended, the Chief Executive Officer of the Company and the Chief Financial Officer of the Company have concluded that the Company’s disclosure controls and procedures are effective as of June 30, 2018.March 31, 2019.

 

Reference should be made to our most recent Annual Report on Form 10-K for additional information regarding discussion of the effectiveness of the Company’s controls and procedures.

 

Changes in internal controls

 

There has been no change in our internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the quarter covered by this report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

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INTERPACE DIAGNOSTICS GROUP, INC.

 

PART II. OTHER INFORMATION

 

Item 1. Legal Proceedings

 

“Item 3- Legal Proceedings” and Note 10,Commitments and Contingencies, to the Consolidated Financial Statements of our most recent Annual Report on Form 10-K, filed with the SEC on March 23, 2018 includes21, 2019 (the “Form 10-K”),include a discussion of our legal proceedings, as does Note 6,7,Commitments and Contingencies, to the accompanying condensed consolidated financial statements.statements furnished herewith. During the fiscal quarter ended June 30, 2018,March 31, 2019, there have been no material changes from the proceedings disclosed in our Form 10-K.

 

Item 1A. Risk Factors.

 

Not applicable as we are a smaller reporting company.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

On June 13th and 15th, 2018, the Company issued 325,000 shares of common stock in consideration of services to be rendered in respect of two consulting agreements it entered into during the quarter ended June 30, 2018. The issuances were exempt from registration pursuant to the Securities Act of 1933, as amended, pursuant to Section 4(a)(2) thereof.None.

 

Item 3. Defaults Upon Senior Securities.

 

None.

 

Item 4. Mine Safety Disclosures.Disclosures

 

None.

 

Item 5. Other Information.

 

None.

 

Item 6. Exhibits

 

Exhibit No. Description
   
31.1 Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, filed herewith.
   
31.2 Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, filed herewith.
   
32.1+ Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, furnished herewith.
   
32.2+ Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, furnished herewith.
   
101 The following financial information from this Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2018March 31, 2019 formatted in XBRL (Extensible Business Reporting Language) and furnished electronically herewith: (i) the Condensed Consolidated Balance Sheets; (ii) the Condensed Consolidated Statements of Operations; (iii) the Condensed Consolidated StatementStatements of Stockholders’ Equity; (iv) the Condensed Consolidated Statements of Cash Flows; and (v) the Notes to Condensed Consolidated Financial Statements.
   
++Exhibits 32.1 and 32.2 are being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall such exhibits be deemed to be incorporated by reference to any registration statement or other document filed under the Securities Act or the Exchange Act, except as otherwise stated in any such filing.

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

Date: August 9, 2018May 14, 2019

Interpace Diagnostics Group, Inc.

 (Registrant)
  
 /s/ Jack E. Stover
 Jack E. Stover
 President and Chief Executive Officer
 (Principal Executive Officer)
  
Date: May 14, 2019/s/ James Early
 James Early
 Chief Financial Officer
 (Principal Financial Officer)

 

Date: May 14, 2019/s/ Thomas Freeburg
 Thomas Freeburg
 Chief Accounting Officer
 (Principal Accounting Officer)

 

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