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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(D) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

Date of Report (Date of earliest event reported): May 12, 2023

 

INTERPACE BIOSCIENCES, INC.

(Exact name of Registrant as specified in its charter)

 

delaware   0-24249   22-2919486

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

Waterview Plaza, Suite 310

2001 Route 46,

Parsippany, NJ 07054

(Address, including zip code, of Principal Executive Offices)

 

(855) 776-6419

Registrant’s telephone number, including area code

 

Not Applicable

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
None   N/A   N/A

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

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. ☐

 

 

 

 
 

 

Item 2.02 Results of Operations and Financial Condition.

 

On May 12, 2023, Interpace Biosciences, Inc. issued a press release announcing its results of operations and financial condition for the quarter ended March 31, 2023. The full text of the press release is set forth as Exhibit 99.1 attached hereto and is incorporated herein by reference.

 

The information in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise stated in such filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit Number   Description
     
99.1   Press Release, dated May 12, 2023
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 
 

 

SIGNATURE

 

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 hereunto duly authorized.

 

  Interpace Biosciences, Inc.
     
  By: /s/ Thomas W. Burnell
  Name: Thomas W. Burnell
  Title: President and Chief Executive Officer

 

Date: May 12, 2023

 

 

 

Exhibit 99.1

 

Interpace Biosciences Announces Record First Quarter 2023 Financial and Business Results

 

  Q1 Revenue of $9.8 million; a 24% increase year-over-year; highest quarter in history
  Q1 Test volume up nearly 20% year over year to record levels
  Q1 41.9 million covered lives added, resulting from 8 new or updated commercial contracts

 

PARSIPPANY, NJ, May 12, 2023 (GLOBE NEWSWIRE) — Interpace Biosciences, Inc. (“Interpace” or the “Company”) (OTCQX: IDXG) today announced financial results for the first quarter ended March 31, 2023 and provided a business and financial update.

 

First quarter Net Revenue was $9.8 million. Operating expenses for the first quarter were approximately 6% lower than the same period of 2022. Income from continuing operations in the first quarter of 2023 was $0.4 million, an improvement of $1.5 million from the prior year quarter’s loss of $1.1 million.

 

“Q1 2023 represented record testing volume and net revenue for the Company, resulting in achievement of profitability and exceeding cash flow breakeven”, stated Tom Burnell, President and CEO of Interpace. “Continued adoption of the Company’s proprietary molecular diagnostics tests (ThyGeNEXT® + ThyraMIR®v2 and PancraGEN®) by physicians and medical professionals has fueled the growth trajectory of the Company. This has set the stage for sales force expansion, and investments in product improvements and laboratory efficiency which may, initially, impact full year profitability.”

 

First Quarter and 2023 Financial Performance

 

For the First Quarter of 2023 as Compared to the First Quarter of 2022

 

  Net Revenue was $9.8 million, an increase of 24% from $7.9 million for the prior year quarter
     
  Gross Profit percentage was 61% compared to 59% for the prior year quarter, an improvement year over year
     
  Operating income was $0.7 million vs an operating loss of $(1.0) million in the prior year quarter
     
  Income from continuing operations was $0.4 million vs a loss from continuing operations of $(1.1) million in the prior year quarter
     
  Adjusted EBITDA was $1.2 million vs $(0.3) million in the prior year quarter
     
  Q1 2023 cash collections totaled $10.2 million
     
  March 31, 2023 cash balance was $5.6 million. March 31, 2022 cash balance was $2.9 million, net of restricted cash

 

About Interpace Biosciences

 

Interpace Biosciences is an emerging leader in enabling personalized medicine, offering specialized services along the therapeutic value chain from early diagnosis and prognostic planning to targeted therapeutic applications.

 

 
 

 

Clinical services, through Interpace Diagnostics, provide clinically useful molecular diagnostic tests and bioinformatics and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for improved patient diagnosis and management. Interpace has five commercialized molecular tests and one test in a clinical evaluation program (CEP): PancraGEN® for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; PanDNA®, a “molecular only” version of PancraGEN that provides physicians a snapshot of a limited number of factors; ThyGeNEXT® for the diagnosis of thyroid cancer from thyroid nodules utilizing a next-generation sequencing assay; ThyraMIR®v2, used in combination with ThyGeNEXT®, for the diagnosis of thyroid cancer utilizing a proprietary microRNA pairwise expression profiler along with algorithmic classification; and RespriDX®, that differentiates lung cancer of primary versus metastatic origin. In addition, BarreGEN®, a molecular-based assay that helps resolve the risk of progression of Barrett’s Esophagus to esophageal cancer, is currently in a CEP, whereby we gather information from physicians using BarreGEN to assist us in gathering clinical evidence relative to the safety and performance of the test and also providing data that will potentially support payer reimbursement.

 

For more information, please visit Interpace Biosciences’ website at www.interpace.com.

 

Forward-looking Statements

 

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to the Company’s future financial and operating performance. The Company has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. These statements also involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results to be materially different from those expressed or implied by any forward-looking statements, including, but not limited to, the reimbursement of the Company’s tests being subject to review by CMS, the Company’s ability to continue to perform, bill and receive reimbursement for our PancraGEN® molecular test under the existing local coverage determination (“LCD”), given that such LCD is currently under review by Novitas Solutions, Inc., the Company’s Medicare administrative contractor, the possibility that the Company’s estimates of future revenue, cash flows and adjusted EBITDA may prove to be materially inaccurate, the Company’s history of operating losses, the Company’s ability to adequately finance its business and seek alternative sources of financing, the Company’s ability to repay borrowings with Comerica Bank and BroadOak, the Company’s dependence on sales and reimbursements from its clinical services, the Company’s ability to retain or secure reimbursement including its reliance on third parties to process and transmit claims to payers and the adverse impact of any delay, data loss, or other disruption in processing or transmitting such claims, the Company’s revenue recognition being based in part on estimates for future collections which estimates may prove to be incorrect, and the possible removal of the Company’s common stock from trading on the OTCQX®.

 

Additionally, all forward-looking statements are subject to the “Risk Factors” detailed from time to time in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as amended, Current Reports on Form 8-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

 

Contacts:

 

Investor Relations

Interpace Biosciences, Inc.

(855)-776-6419

[email protected]

 

 
 

 

 

INTERPACE BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited, in thousands, except per share data)

 

   Three Months Ended 
   March 31, 
   2023   2022 
         
Revenue, net  $9,826   $7,923 
Cost of revenue   3,848    3,265 
Gross Profit   5,978    4,658 
           
Sales and marketing   2,342    2,200 
Research and development   149    231 
General and administrative   2,494    2,886 
Acquisition amortization expense   318    318 
Total operating expenses   5,303    5,635 
           
Operating income (loss)   675    (977)
Interest accretion expense   (35)   (121)
Note payable interest   (225)   (180)
Other income, net   19    161 
Income (loss) from continuing operations before tax   434    (1,117)
Provision for income taxes   4    18 
Income (loss) from continuing operations   430    (1,135)
           
Loss from discontinued operations, net of tax   (79)   (1,112)
           
Net income (loss)  $351   $(2,247)
           
Basic income (loss) per share of common stock:          
From continuing operations  $0.10   $(0.27)
From discontinued operations   (0.02)   (0.26)
Net loss per basic share of common stock  $0.08   $(0.53)
           
Diluted income (loss) per share of common stock:          
From continuing operations  $0.10   $(0.27)
From discontinued operations   (0.02)   (0.26)
Net loss per basic share of common stock  $0.08   $(0.53)
           
Weighted average number of common shares and common share equivalents outstanding:          
Basic   4,307    4,208 
Diluted   4,308    4,208 

 

 
 

 

Selected Balance Sheet Data (Unaudited)

($ in thousands)

 

   March 31,   December 31, 
   2023   2022 
Cash and cash equivalents  $5,596   $4,828 
           
Total current assets   12,484    12,154 
Total current liabilities   13,851    14,283 
           
Total assets   15,877    15,979 
Total liabilities   31,879    32,515 
Total stockholders’ deficit   (62,538)   (63,072)

 

Selected Cash Flow Data (Unaudited)

($ in thousands)

 

   For the Three Months Ended 
   March 31, 
   2023   2022 
Net income (loss)  $351   $(2,247)
           
Net cash provided (used in) operating activities  $1,133   $(1,254)
Net cash used in investing activities   (65)   (19)
Net cash (used in) provided by financing activities   (300)   1,059 
Change in cash, cash equivalents and restricted cash   768    (214)
Cash, cash equivalents and restricted cash – beginning   4,828    3,314 
Cash, cash equivalents and restricted cash – ending  $5,596   $3,100 

 

Reconciliation of Adjusted EBITDA (Unaudited)

($ in thousands)

 

   Three Months Ended 
   March 31, 
   2023   2022 
Income (loss) from continuing operations (GAAP Basis)  $430   $(1,135)
Depreciation and amortization   356    371 
Stock-based compensation   192    303 
Taxes expense   4    18 
Interest accretion expense   35    121 
Note payable interest   225    180 
Mark to market on warrant liability   -    (63)
Change in fair value of note payable   (33)   (107)
Adjusted EBITDA  $1,209   $(312)

 

Non-GAAP Financial Measures

 

In addition to the United States generally accepted accounting principles, or GAAP, results provided throughout this document, we have provided certain non-GAAP financial measures to help evaluate the results of our performance. We believe that these non-GAAP financial measures, when presented in conjunction with comparable GAAP financial measures, are useful to both management and investors in analyzing our ongoing business and operating performance. We believe that providing the non-GAAP information to investors, in addition to the GAAP presentation, allows investors to view our financial results in the way that management views financial results.

 

In this document, we discuss Adjusted EBITDA, a non-GAAP financial measure. Adjusted EBITDA is a metric used by management to measure cash flow of the ongoing business. Adjusted EBITDA is defined as income or loss from continuing operations, plus depreciation and amortization, non-cash stock based compensation and ESPP plans, interest and taxes, and other non-cash expenses including change in fair values of notes payable, contingent consideration and warrant liability. The table above includes a reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure.