UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended March 31, 2023
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
Biosciences, 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.)
Waterview Plaza , Suite 310 , 2001 Route 46 , Parsippany , NJ 07054
(Address
of principal executive offices and zip code)
(855)
776-6419
(Registrant’s
telephone number, including area code)
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 (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 ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files). Yes ☒ No☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”,
“smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ☐
Accelerated
filer ☐
Non-accelerated
filer ☒
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 Exchange Act). Yes ☐ No ☒
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 May 5, 2023
Common
Stock, par value $0.01 per share
4,311,414
INTERPACE
BIOSICENCES, INC.
FORM
10-Q FOR PERIOD ENDED MARCH 31, 2023
TABLE
OF CONTENTS
Page No.
PART I - FINANCIAL INFORMATION
Item
1.
Unaudited Interim Condensed Consolidated Financial Statements
3
Condensed Consolidated Balance Sheets at March 31, 2023 (unaudited) and December 31, 2022
3
Condensed Consolidated Statements of Operations for the three-month periods ended March 31, 2023 and 2022 (unaudited)
4
Condensed Consolidated Statements of Stockholders’ Deficit for the three-month periods ended March 31, 2023 and 2022 (unaudited)
5
Condensed Consolidated Statements of Cash Flows for the three-month periods ended March 31, 2023 and 2022 (unaudited)
6
Notes to Unaudited Condensed Consolidated Financial Statements
7
Item
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
22
Item
3.
Quantitative and Qualitative Disclosures About Market Risk
29
Item
4.
Controls and Procedures
29
PART II - OTHER INFORMATION
Item
1.
Legal Proceedings
30
Item
1A.
Risk Factors
30
Item
2.
Unregistered Sales of Equity Securities and Use of Proceeds
30
Item
3.
Defaults Upon Senior Securities
30
Item
4.
Mine Safety Disclosures
30
Item
5.
Other Information
30
Item
6.
Exhibits
30
Signatures
31
2
PART
I. FINANCIAL INFORMATION
INTERPACE
BIOSCIENCES, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands, except share and per share data)
March 31,
December 31,
2023
2022
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$ 5,596
$ 4,828
Accounts receivable
4,715
5,032
Other current assets
2,173
2,294
Total current assets
12,484
12,154
Property and equipment, net
506
480
Other intangible assets, net
544
861
Operating lease right of use assets
2,298
2,439
Other long-term assets
45
45
Total assets
$ 15,877
$ 15,979
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable
$ 1,582
$ 1,050
Accrued salary and bonus
888
1,456
Other accrued expenses
8,323
8,419
Line of credit - current
2,200
2,500
Current liabilities of discontinued operations
858
858
Total current liabilities
13,851
14,283
Contingent consideration
368
518
Operating lease liabilities, net of current portion
1,748
1,848
Note payable at fair value
11,132
11,165
Other long-term liabilities
4,780
4,701
Total liabilities
31,879
32,515
Commitments and contingencies (Note 9)
-
-
Redeemable preferred stock, $ .01 par value; 5,000,000 shares authorized, 47,000 shares Series B issued
and outstanding
46,536
46,536
Stockholders’ deficit:
Common stock, $ .01 par value; 100,000,000 shares authorized; 4,390,826 and 4,367,830 shares issued,
respectively; 4,311,414 and 4,296,710 shares outstanding, respectively
405
405
Additional paid-in capital
187,708
187,516
Accumulated deficit
( 248,666 )
( 249,017 )
Treasury stock, at cost ( 79,412 and 71,120 shares, respectively)
( 1,985 )
( 1,976 )
Total stockholders’ deficit
( 62,538 )
( 63,072 )
Total liabilities and stockholders’ deficit
( 30,659 )
( 30,557 )
Total liabilities, preferred stock and stockholders’ deficit
$ 15,877
$ 15,979
The
accompanying notes are an integral part of these condensed consolidated financial statements
3
INTERPACE
BIOSCIENCES, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited,
in thousands, except for per share data)
2023
2022
For The 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
Operating expenses:
Sales and marketing
2,342
2,200
Research and development
149
231
General and administrative
2,494
2,886
Acquisition related amortization expense
318
318
Total operating expenses
5,303
5,635
Operating income (loss) from continuing operations
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 income (loss) per basic and diluted 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 income (loss) per basic and diluted 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
The
accompanying notes are an integral part of these condensed consolidated financial statements
4
INTERPACE
BIOSCIENCES, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT
(unaudited,
in thousands)
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Additional
Common Stock
Treasury Stock
Paid in
Accumulated
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Balance -December 31, 2021
4,228,169
$ 403
32,757
$ ( 1,868 )
$ 186,106
$ ( 227,059 )
$ ( 42,418 )
Issuance of common stock
44,139
1
-
-
58
-
59
Treasury stock purchased
-
13,129
( 60 )
-
-
( 60 )
Stock-based compensation expense
-
-
-
-
325
-
325
Net loss
-
-
-
-
-
( 2,247 )
( 2,247 )
Balance -March 31, 2022
4,272,308
$ 404
45,886
$ ( 1,928 )
$ 186,489
$ ( 229,306 )
$ ( 44,341 )
Balance -December 31, 2022
4,367,830
$ 405
71,120
$ ( 1,976 )
$ 187,516
$ ( 249,017 )
$ ( 63,072 )
Balance, value
4,367,830
$ 405
71,120
$ ( 1,976 )
$ 187,516
$ ( 249,017 )
$ ( 63,072 )
Issuance of common stock
22,996
-
-
-
-
-
-
Treasury stock purchased
-
8,292
( 9 )
-
-
( 9 )
Stock-based compensation expense
-
-
-
-
192
-
192
Net income
-
-
-
-
-
351
351
Net income (loss)
-
-
-
-
-
351
351
Balance -March 31, 2023
4,390,826
$ 405
79,412
$ ( 1,985 )
$ 187,708
$ ( 248,666 )
$ ( 62,538 )
Balance, value
4,390,826
$ 405
79,412
$ ( 1,985 )
$ 187,708
$ ( 248,666 )
$ ( 62,538 )
The
accompanying notes are an integral part of these condensed consolidated financial statements.
5
INTERPACE
BIOSCIENCES, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited,
in thousands)
2023
2022
`
For The Three Months Ended March 31,
2023
2022
Cash Flows From Operating Activities
Net income (loss)
$ 351
$ ( 2,247 )
Adjustments to reconcile net income (loss) to net cash used in operating activities:
Depreciation and amortization
356
781
Interest accretion expense
35
121
Amortization of deferred financing fees
14
10
Stock-based compensation
192
302
ESPP expense
-
23
Change in fair value of note payable
( 33 )
( 107 )
Mark to market on warrants
-
( 63 )
Other changes in operating assets and liabilities:
Accounts receivable
317
( 1,083 )
Other current assets
107
( 83 )
Other long-term assets
-
( 1 )
Accounts payable
532
1,235
Accrued salaries and bonus
( 568 )
377
Accrued liabilities
( 249 )
( 556 )
Long-term liabilities
79
37
Net cash provided by (used in) operating activities
1,133
( 1,254 )
Cash Flows From Investing Activity
Purchase of property and equipment
( 65 )
( 19 )
Net cash used in investing activities
( 65 )
( 19 )
Cash Flows From Financing Activities
Issuance of common stock, net of expenses
-
59
(Payments) borrowings on line of credit
( 300 )
1,000
Net cash (used in) provided by financing activities
( 300 )
1,059
Net increase (decrease) in cash, cash equivalents and restricted cash
768
( 214 )
Cash, cash equivalents and restricted cash from continuing operations– beginning
4,828
2,922
Cash, cash equivalents and restricted cash from discontinued operations– beginning
-
392
Cash, cash equivalents and restricted cash – beginning
$ 4,828
$ 3,314
Cash, cash equivalents and restricted cash from continuing operations– ending
$ 4,828
$ 2,813
Cash, cash equivalents and restricted cash from discontinued operations– ending
-
287
Cash, cash equivalents and restricted cash – ending
$ 5,596
$ 3,100
The
accompanying notes are an integral part of these condensed consolidated financial statements.
6
INTERPACE
BIOSCIENCES, INC.
NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(Tabular
information in thousands, except per share amounts)
1. OVERVIEW
Nature
of Business
Interpace
Biosciences, Inc. (“Interpace” or the “Company”) is a company that provides molecular diagnostics, bioinformatics
and pathology services for evaluation of risk of cancer by leveraging the latest technology in personalized medicine for improved patient
diagnosis and management. The Company develops and commercializes genomic tests and related first line assays principally focused on
early detection of patients with indeterminate biopsies and at high risk of cancer using the latest technology.
2. 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 the Company 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, 2022, as filed with the Securities & Exchange Commission (“SEC”)
on March 27, 2023 and as amended on April 28, 2023.
The
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 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, InServe Support Solutions;
and TVG, Inc., its Commercial Services business unit which was sold on December 22, 2015 and its Interpace Pharma Solutions business
(“Pharma Solutions”) which was sold on August 31, 2022. All significant intercompany balances and transactions have been
eliminated in consolidation. Operating results for the three-month period ended March 31, 2023 are not necessarily indicative of the
results that may be expected for the fiscal year ending December 31, 2023.
3. GOING CONCERN
In
October 2021, the Company entered into a $ 7.5 million revolving credit facility with Comerica Incorporated (“Comerica”) (the
“Comerica Loan Agreement”). See Note 17, Revolving Line of Credit , for more details. Also in October 2021, the Company
entered into an $ 8.0 million term loan with BroadOak Fund V, L.P. (“BroadOak”) (the “BroadOak Term Loan”), the
proceeds of which were used to repay in full at their maturity the existing secured promissory note with Ampersand Capital Partners (“Ampersand”)
(the “Ampersand Note”) and 1315 Capital II, L.P (“1315 Capital”) (the “1315 Capital Note”). In May
2022, the Company entered into a Subordinated Convertible Promissory Note agreement with BroadOak for an additional $ 2.0 million (the
“Convertible Note”), which was converted into a subordinated term loan and was added to the outstanding BroadOak Term Loan
balance. See Note 14, Notes Payable , for more details.
7
In
January 2022, the Company’s registration statement for a rights offering filed with the Securities and Exchange Commission (SEC)
became effective; however, the rights offering was subsequently terminated later in January 2022 when the Company announced that the
Centers for Medicare & Medicaid Services, or CMS, issued a new billing policy whereby CMS will no longer reimburse for the use of
the Company’s ThyGeNEXT ® and ThyraMIR ® tests when billed together by the same provider/supplier for
the same beneficiary on the same date of service. However, on February 28, 2022, the Company announced that the National Correct Coding
Initiative (NCCI) program issued a response on behalf of CMS stating that the January 2022 billing policy reimbursement change for ThyGeNEXT ®
(0245U) and ThyraMIR ® (0018U) tests has been retroactively reversed to January 1, 2022. In May 2022, the Company
was notified by CMS/NCCI that processing of claims for dates of service after January 1, 2022 would be completed beginning July 1, 2022.
However, on June 9, 2022, the Company was notified that our local Medicare Administrator Contractor, Novitas re-priced ThyGeNEXT ®
(0245U) from $ 2,919 to $ 806.59 retroactively effective to January 1, 2022. On July 20, 2022 the Clinical Diagnostic Laboratory
Tests (CDLT) Advisory Panel affirmed a gapfill price for ThyGeNEXT ® of $ 806.59 . As a result of the ThyGeNEXT ®
pricing change, the Company reduced its net realizable value, or NRV rates, for ThyGeNEXT ® Medicare billing to reflect
the $ 806.59 pricing for tests performed during the second quarter of 2022. In addition, in order to reflect the retroactive pricing change
to January 1, 2022, the Company recorded an NRV adjustment of $ 0.7 million during the second quarter of 2022 to reduce revenue recorded
during the first quarter of 2022. Effective January 1, 2023, the gapfill price for ThyGeNEXT ® was set at $ 1,266.07 .
Further,
along with many laboratories, the Company may be affected by the Proposed Local Coverage Determination (“LCD”) DL39365, which
was posted on June 9, 2022 and is currently under consideration by Novitas. If finalized, this Proposed LCD, which governs “Genetic
Testing for Oncology,” could impact the existing LCD for one of our molecular tests, PancraGEN ® . If Novitas restricts
coverage for PancraGEN ® , the Company’s liquidity could be negatively impacted beginning in Fiscal 2023.
For
the three months ended March 31, 2023, the Company had operating income from continuing operations of $ 0.7 million. As of March 31, 2023,
the Company had cash and cash equivalents of $ 5.6 million, total current assets of $ 12.5 million and current liabilities of $ 13.9 million.
As of May 8, 2023, the Company had approximately $ 6.7 million of cash on hand.
The
Company may not generate positive cash flows from operations for the year ending December 31, 2023. The Company intends to meet its ongoing
capital needs by using its available cash and availability under the Comerica Loan Agreement, as well as through targeted margin improvement;
collection of accounts receivable; containment of costs; and the potential use of other financing options and other strategic alternatives.
However, if the Company is unable to meet the financial covenants under the Comerica Loan Agreement, the revolving line of credit and
notes payable will become due and payable immediately. As of May 1, 2023, the Company had $ 2.2 million available under the Loan Agreement.
The
Company continues to explore various strategic alternatives, dilutive and non-dilutive sources of funding, including equity and debt
financings, strategic alliances, business development and other sources in order to provide additional liquidity. With the delisting
of its common stock from Nasdaq in February 2021, and the possible removal of its common stock from trading on the OTCQX ® if
it fails to meet minimum market capitalization of $ 5 million by July 3, 2023, the Company’s ability to raise additional capital
on terms acceptable to it has been adversely impacted. There can be no assurance that the Company will be successful in obtaining such
funding on terms acceptable to it.
The
Company’s consolidated financial statements assumes the Company will continue as a going concern. Its ability to continue as a
going concern depends on having working capital for vendor payments, meeting short-term obligations on other accrued liabilities, and
amongst other requirements, making interest payments on its debt obligations. Without positive operating margins and sufficient working
capital and the ability to meet its debt obligations, our business will be jeopardized and we may not be able to continue in our current
structure, if at all. Under these circumstances, the Company would likely have to consider other options, such as selling assets, raising
additional debt or equity capital, cutting costs or otherwise reducing our cash requirements, or negotiating with our creditors to restructure
our applicable obligations. With the proceeds received from the sale of the Pharma Solutions business, as well as the expected improvement
in future operating cash flows associated with the disposition, as of the date of this filing, the Company anticipates that current cash
and cash equivalents and forecasted cash receipts will be sufficient to meet its anticipated cash requirements through the next twelve
months.
8
4. DISCONTINUED OPERATIONS
Liabilities
classified as discontinued operations as of both March 31, 2023 and December 31, 2022 consists of accrued expenses of which $ 766 of liabilities
related to the former Commercial Services business unit.
The
table below presents the significant components of its former Pharma Solutions business unit’s results included within loss from
discontinued operations, net of tax in the condensed consolidated statements of operations for the three- months ended March 31, 2023
and 2022.
SCHEDULE
OF COMPONENTS OF ASSETS AND LIABILITIES AND REVENUE CLASSIFIED AS DISCONTINUED OPERATIONS
2023
2022
For The Three Months Ended
March 31,
2023
2022
Revenue, net
$ -
$ 2,454
Loss from discontinued operations
-
( 1,058 )
Income tax expense
79
54
Loss from discontinued operations, net of tax
$ ( 79 )
$ ( 1,112 )
Cash
used from discontinued operations, operating activities, for the three months ended March 31, 2022 was approximately $ 1.1
million. There was no
cash flow activity from discontinued operations for the three months ended March 31, 2023. Depreciation and amortization expense within discontinued operations for the three months ended March 31, 2022 was
$ 0.4 million. There was no depreciation and amortization expense for the three months ended March 31, 2023.
5. 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 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.
Revenue
Recognition
We
derive our revenues from the performance of proprietary assays or tests. The Company’s performance obligation is fulfilled upon
the completion, review and release of test results to the customer. The Company subsequently bills third-party payers or direct-bill
payers for the tests performed. Under Accounting Standards Codification 606, revenue is recognized based on the estimated transaction
price or net realizable value, 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.
We
regularly review the ultimate amounts received from the third-party and direct-bill payers and related estimated reimbursement rates
and adjust 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 affects net revenue in the period such variances become
known.
For
our Pharma Solutions services, project level activities, including study setup and project management, were satisfied over the life of
the contract while performance-related obligations were satisfied at a point in time as the Company processes samples delivered by the
customer. Revenues were recognized at a point in time when the test results or other deliverables are reported to the customer.
9
Financing
and Payment
For
non-Medicare claims, our payment terms vary by payer category. Payment terms for direct-payers in our clinical services are typically
thirty days and in our pharma services, up to sixty 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
claims may be subject to a denial and appeal process, which could take up to two years in some instances where multiple appeals are submitted.
The Company generally appeals all denials from commercial third-party payers. We bill Medicare directly for tests performed for Medicare
patients and must accept Medicare’s fee schedule for the covered tests as payment in full.
Costs
to Obtain or Fulfill a Customer Contract
Sales
commissions are expensed in the period in which they have been earned. 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 clinical services and
Pharma Solutions services. The Company’s clinical 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. Contractual
adjustments represent the difference between the list prices and the reimbursement rates set by third-party payers, including Medicare,
commercial payers, and amounts billed to direct-bill payers. 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 8, Leases .
10
Other
Current Assets
Other
current assets consisted of the following as of March 31, 2023 and December 31, 2022:
SCHEDULE OF OTHER CURRENT ASSETS
March 31, 2023
December 31, 2022
Lab supplies
$ 1,174
$ 1,224
Prepaid expenses
327
390
Funds in escrow
500
500
Other
172
180
Total other current assets
$ 2,173
$ 2,294
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 ten 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.
Basic
and Diluted Net Loss per Share
A
reconciliation of the number of shares of common stock, par value $ 0.01 per share, used in the calculation of basic and diluted loss
per share for the three- month periods ended March 31, 2023 and 2022 is as follows:
SCHEDULE OF BASIC AND DILUTED NET LOSS PER SHARE
2023
2022
Three Months Ended
March 31,
2023
2022
Basic weighted average number of common shares
4,307
4,208
Potential dilutive effect of stock-based awards
1
-
Diluted weighted average number of common shares
4,308
4,208
The
Company’s Series B Convertible Preferred Stock, on an as converted basis into common stock of 7,833,334 shares for the three- month
periods ended March 31, 2023 and 2022, and the following outstanding stock-based awards and warrants, were excluded from the computation
of the effect of dilutive securities on loss per share for the following periods as they would have been anti-dilutive (rounded to thousands):
SCHEDULE OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE
2023
2022
Three Months Ended
March 31,
2023
2022
Options
526
641
Restricted stock units (RSUs)
219
319
Warrants
-
1,339
Antidilutive
securities excluded from computation of earnings per share
745
2,299
11
6. GOODWILL AND OTHER INTANGIBLE ASSETS
The
net carrying value of the identifiable intangible assets from all acquisitions within continuing operations as of March 31, 2023 and
December 31, 2022 are as follows:
SCHEDULE OF IDENTIFIABLE INTANGIBLE ASSETS CARRYING VALUE
As of March 31,
2023
As of
December 31,
2022
Life
Carrying
Carrying
(Years)
Amount
Amount
Asuragen acquisition:
Thyroid
9
$ 8,519
$ 8,519
RedPath acquisition:
Pancreas test
7
16,141
16,141
Barrett’s test
9
6,682
6,682
CLIA Lab
2.3
609
609
Total
$ 31,951
$ 31,951
Accumulated Amortization
( 31,407 )
( 31,090 )
Net Carrying Value
$ 544
$ 861
Amortization
expense from continuing operations was approximately $ 0.3 million for both the three-month periods ended March 31, 2023 and 2022, respectively.
The remaining amortization expense of $ 0.5 million will be amortized in 2023.
7. 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, warrant
liability and note payable. 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
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.
12
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, is set forth in the tables below:
SCHEDULE
OF FINANCIAL INSTRUMENT MEASURED ON RECURRING BASIS
As of March 31, 2023
Fair Value Measurements
Fair
As of March 31, 2023
Amount
Value
Level 1
Level 2
Level 3
Liabilities:
Contingent consideration:
Asuragen ( 1)
$ 933
$ 933
$ -
$ -
$ 933
Note payable:
BroadOak loan
10,000
11,132
-
-
11,132
$ 10,933
$ 12,065
$ -
$ -
$ 12,065
(1)
See
Note 10, Other Accrued Expenses
As of December 31, 2022
Fair Value Measurements
Fair
As of December 31, 2022
Amount
Value
Level 1
Level 2
Level 3
Liabilities:
Contingent consideration:
Asuragen (1)
$ 1,088
$ 1,088
$ -
$ -
$ 1,088
Note payable:
BroadOak loan
10,000
11,165
-
-
11,165
$ 11,088
$ 12,253
$ -
$ -
$ 12,253
(1)
See
Note 10, Other Accrued Expenses
In
connection with the acquisition of certain assets from Asuragen, Inc., 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.
In
connection with the BroadOak loan, the Company records the loan at fair value. The fair value of the loan is determined by a probability-weighted
approach regarding the loan’s change in control feature. See Note 14, Notes Payable , for more details. The fair value measurement
is based on the estimated probability of a change in control and thus represents a Level 3 measurement.
13
A
roll forward of the carrying value of the Contingent Consideration Liability and BroadOak loans to March 31, 2023 is as follows:
SCHEDULE
OF FAIR VALUE, ASSETS MEASURED ON RECURRING BASIS, UNOBSERVABLE INPUT RECONCILIATION
Adjustment
December 31,
Transferred
to Accrued
Accretion/
Interest
to Fair
Value/
Mark to
March 31,
2022
Issued
Expenses
Accrued
Market
2023
Asuragen
$ 1,088
$ -
$ ( 190 )
$ 35
$ -
$ 933
BroadOak loans
11,165
-
-
-
( 33 )
11,132
$ 12,253
$ -
$ ( 190 )
$ 35
$ ( 33 )
$ 12,065
Certain
of the Company’s non-financial assets, such as other intangible assets, are measured at fair value on a nonrecurring basis when
there is an indicator of impairment and recorded at fair value only when an impairment charge is recognized.
8. LEASES
The
table below presents the lease-related assets and liabilities recorded in the Condensed Consolidated Balance Sheet:
SCHEDULE
OF LEASE RELATED ASSETS AND LIABILITIES
Classification on the Balance Sheet
March 31, 2023
December 31, 2022
Assets
Operating lease assets
Operating lease right of use assets
2,298
2,439
Total lease assets
$ 2,298
$ 2,439
Liabilities
Current
Operating lease liabilities
Other accrued expenses
542
578
Operating lease liabilities
Other accrued expenses
542
578
Total current lease liabilities
$ 542
$ 578
Noncurrent
Operating lease liabilities
Operating lease liabilities, net of current portion
1,748
1,848
Total long-term lease liabilities
1,748
1,848
Total lease liabilities
$ 2,290
$ 2,426
The
weighted average remaining lease term for the Company’s operating leases was 4.8 years as of March 31, 2023 and the weighted average
discount rate for those leases was 11.8 %. The Company’s operating lease expenses are recorded within “Cost of revenue”
and “General and administrative expenses.”
14
The
table below reconciles the cash flows to the lease liabilities recorded on the Company’s Condensed Consolidated Balance Sheet as
of March 31, 2023:
SCHEDULE
OF MATURITIES OF OPERATING LEASE LIABILITIES
Operating Leases
2023 - remaining nine months
$ 627
2024
575
2025
450
2026
550
2027-2028
825
Total minimum lease payments
3,027
Less: amount of lease payments representing effects of discounting
737
Present value of future minimum lease payments
2,290
Less: current obligations under leases
542
Long-term lease obligations
$ 1,748
In
April 2023, the Company entered into a lease termination agreement with its Parsippany landlord. See Note 19, Subsequent Events ,
for more detail.
9. COMMITMENTS AND CONTINGENCIES
Litigation
From
time to time, the Company may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business.
When the Company is aware of a claim or potential claim, it assesses the likelihood of any loss or exposure. If it is probable that a
loss will result and the amount of the loss can be reasonably estimated, the Company will record a liability for the loss. In addition
to the estimated loss, the recorded liability includes probable and estimable legal costs associated with the claim or potential claim.
Litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may
harm the Company’s business. There is no pending litigation involving the Company at this time.
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 or services that 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. There is also the risk of employment related litigation and other litigation in the ordinary course of business.
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.
15
10. OTHER ACCRUED EXPENSES
Other
accrued expenses consisted of the following as of March 31, 2023 and December 31, 2022:
SCHEDULE
OF OTHER ACCRUED EXPENSES
March 31, 2023
December 31, 2022
Accrued royalties
$ 5,293
$ 4,909
Contingent consideration
565
569
Operating lease liability
542
578
Accrued sales and marketing - diagnostics
-
40
Accrued lab costs - diagnostics
156
167
Accrued professional fees
512
641
Taxes payable
279
262
Unclaimed property
447
565
All others
529
688
Total other accrued expenses
$ 8,323
$ 8,419
11. STOCK-BASED COMPENSATION
Historically,
stock options have been granted with an exercise price equal to the market value of the common stock on the date of grant, with expiration
10 years from the date they are granted, and generally vest over a one to three-year period for employees and members of the Board. Upon
exercise, new shares will be issued by the Company. The restricted shares and restricted stock units (“RSUs”) granted to
Board members and employees generally have a three-year graded vesting period and are subject to accelerated vesting and forfeiture under
certain circumstances .
The
following table provides the weighted average assumptions used in determining the fair value of the stock option awards granted during
the three-month period ended March 31, 2022. There were no stock option awards issued in the three months ended March 31, 2023.
SCHEDULE
OF STOCK OPTIONS, VALUATION ASSUMPTIONS
March 31, 2022
Risk-free interest rate
1.75 %
Expected life
6.0 years
Expected volatility
129.93 %
Dividend yield
-
The
Company recognized approximately $ 0.2 million and $ 0.3 million of stock-based compensation expense within continuing operations during
the three-month periods ended March 31, 2023 and 2022, respectively. The following table has a breakout of stock-based compensation expense
from continuing operations by line item.
SCHEDULE OF SHARE-BASED COMPENSATION ARRANGEMENTS BY SHARE-BASED PAYMENT AWARD
2023
2022
Three Months Ended
March 31,
2023
2022
Cost of revenue
$ 14
$ 27
Sales and marketing
30
44
Research and development
-
-
General and administrative *
148
232
Total stock compensation expense
$ 192
$ 303
*
Includes
ESPP expense in 2022
16
12. 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 income (loss) from continuing operations and the effective
tax rate for the three- month periods ended March 31, 2023 and 2022:
SCHEDULE OF EFFECTIVE INCOME TAX RATE
2023
2022
Three Months Ended
March 31,
2023
2022
Provision for income tax
$ 4
$ 18
Effective income tax rate
0.9 %
( 1.6 %)
Income
tax expense for both periods was primarily due to Texas franchise taxes.
Other
long-term liabilities consisted of uncertain tax positions as of March 31, 2023 and December 31, 2022.
13. SEGMENT INFORMATION
We
operate under one segment which is the business of developing and selling clinical services.
14. NOTES PAYABLE
BroadOak
Loan
On
October 29, 2021, the Company and its subsidiaries entered into the BroadOak Loan Agreement, providing for a term loan in the aggregate
principal amount of $ 8,000,000 (the “Term Loan”). Funding of the Term Loan took place on November 1, 2021. The Term Loan
matures upon the earlier of (i) October 31, 2024 or (ii) the occurrence of a change in control, and bears interest at the rate of 9 %
per annum. The Term Loan is secured by a security interest in substantially all of the Company’s and its subsidiaries’ assets
and is subordinate to the Company’s $ 7,500,000 revolving credit facility with Comerica Bank. See Note 17, Revolving Line of
Credit . The Term Loan had an origination fee of 3 % of the Term Loan amount, and a terminal payment equal to (i) 15% of the original
principal amount of the Term Loan if the change of control occurs on or prior to the first anniversary of the funding of the Term Loan,
(ii) 20% of the original principal amount of the Term Loan if the change of control occurs after the first anniversary but on or prior
to the second anniversary of the funding of the Term Loan and (iii) 30% of the original principal amount of the Term Loan if the change
of control occurs after the second anniversary of the funding of the Term Loan, or if the Term Loan is repaid on its maturity date .
The
BroadOak Loan Agreement contains affirmative and negative restrictive covenants that are applicable from and after the date of the Term
Loan advance. These restrictive covenants, which include restrictions on certain mergers, acquisitions, investments, encumbrances, etc.,
could adversely affect our ability to conduct our business. The BroadOak Loan Agreement also contains customary events of default.
17
In
connection with the BroadOak Loan Agreement, the Company and its subsidiaries entered into that certain First Amendment to Loan and Security
Agreement and Consent with Comerica, dated as of November 1, 2021 (the “Comerica Amendment”), pursuant to which Comerica
consented to the Company’s and its subsidiaries’ entry into the BroadOak Loan Agreement, and amended that certain Loan and
Security Agreement among Comerica, the Company and its subsidiaries (the “Comerica Loan Agreement”) to, among other things,
permit the indebtedness, liens and encumbrances contemplated by the BroadOak Loan Agreement.
As
a condition for BroadOak to extend the Term Loan to the Company and its subsidiaries, the Company’s existing creditor, Comerica,
and BroadOak entered into that certain Subordination and Intercreditor Agreement, dated as of November 1, 2021, pursuant to which BroadOak
agreed to subordinate all of the indebtedness and obligations of the Company and its subsidiaries owing to BroadOak to all of the indebtedness
and obligations of the Company and its subsidiaries owing to Comerica (the “Intercreditor Agreement”). BroadOak further agreed
to subordinate all of its respective security interests in assets or property of the Company and its subsidiaries to Comerica’s
security interests in such assets or property. The Intercreditor Agreement provides that it is solely for the benefit of BroadOak and
Comerica and is not for the benefit of the Company or any of its subsidiaries.
The
Company concluded that the Note met the definition of a “recognized financial liability” which is an acceptable financial
instrument eligible for the fair value option under ASC 825-10-15-4, and did not meet the definition of any of the financial instruments
listed within ASC 825-10-15-5 that are not eligible for the fair value option. The Note is not convertible and does not have any component
recorded to shareholders’ equity. Accordingly, the Company elected the fair value option for the Note.
BroadOak
Convertible Note
On
May 5, 2022, the Company issued a Convertible Note to BroadOak, pursuant to which BroadOak funded an aggregate principal amount of $ 2
million (the “Convertible Debt”).
The
Convertible Note was to be converted into shares of common stock of the Company in connection with, and upon the consummation of, a private
placement transaction pursuant to which the Company would issue common stock to certain investors, and such conversion would be subject
to the same terms and conditions (including purchase price per share) applicable to the purchase of common stock of the Company by such
investors. Since the private placement transaction was not consummated by August 5, 2022 (the “Maturity Date”), the Convertible
Note was converted into an additional term loan advance under the Company’s existing BroadOak Loan Agreement on the Maturity Date.
The Convertible Debt bore interest at a fixed rate of 9.0 % per annum and was unsecured. There were no scheduled amortization payments
prior to the Maturity Date. The Convertible Note contained customary representations and warranties and customary events of default.
The
Company entered into a) a consent letter (the “Comerica Consent”) with Comerica, pursuant to which Comerica consented to
the issuance of the Convertible Note, the incurrence of the Convertible Debt and the conversion of the Convertible Debt into common stock
of the Company or an additional term loan advance under the BroadOak Loan Agreement.
18
15. SUPPLEMENTAL CASH FLOW INFORMATION
Supplemental
Disclosures of Non Cash Activities
(in
thousands)
SUPPLEMENTAL
CASH FLOW INFORMATION
Three Months Ended
March 31,
2023
2022
Taxes accrued for repurchase of restricted shares
$ 9
$ 60
Accrued capital expenditures
-
22
16. MEZZANINE EQUITY
Redeemable
Preferred Stock
On
January 10, 2020, the Company entered into a Securities Purchase and Exchange Agreement (the “Securities Purchase and Exchange
Agreement”) with 1315 Capital and Ampersand (collectively, the “Investors”) pursuant to which the Company agreed to
sell to the Investors an aggregate of $ 20.0 million in Series B Preferred Stock of the Company, at an issuance price per share of $ 1,000 .
Pursuant to the Securities Purchase and Exchange Agreement, 1315 Capital agreed to purchase 19,000 shares of Series B Preferred Stock
at an aggregate purchase price of $ 19.0 million and Ampersand agreed to purchase 1,000 shares of Series B Preferred Stock at an aggregate
purchase price of $ 1.0 million.
In
addition, the Company agreed to exchange $ 27.0 million of the Company’s existing Series A convertible preferred stock, par value
$ 0.01 per share, held by Ampersand (the “Series A Preferred Stock”), represented by 270 shares of Series A Preferred Stock
with a stated value of $ 100,000 per share, which represents all of the Company’s issued and outstanding Series A Preferred Stock,
for 27,000 newly issued shares of Series B Preferred Stock (such shares of Series B Preferred Stock, the “Exchange Shares”
and such transaction, the “Exchange”). Following the Exchange, no shares of Series A Preferred Stock remained designated,
authorized, issued or outstanding. The Series B Preferred Stock has a conversion price of $ 6.00 .
Voting
On
any matter presented to the stockholders of the Company for their action or consideration at any meeting of stockholders of the Company
(or by written consent of stockholders in lieu of meeting), each holder of outstanding shares of Series B Preferred Stock will be entitled
to cast the number of votes equal to the number of whole shares of the Company’s Common Stock into which the shares of Series B
Preferred Stock held by such holder are convertible as of the record date for determining stockholders entitled to vote on such matter.
Except as provided by law or by the Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred
Stock (the “Certificate of Designation”), holders of Series B Preferred Stock will vote together with the holders of Common
Stock as a single class and on an as-converted to Common Stock basis.
Director
Designation Rights
The
Certificate of Designation also provides each Investor with the following director designation rights: for so long such Investor holds
at least sixty percent (60%) of the Series B Preferred Stock issued to it on the Issuance Date (as defined therein), such Investor will
be entitled to elect two directors to the Company’s Board of Directors (the “Board”), provided that one of the directors
qualifies as an “independent director” under Rule 5605(a)(2) of the listing rules of the Nasdaq Stock Market (or any successor
rule or similar rule promulgated by another exchange on which the Company’s securities are then listed or designated) (“Independent
Director”). However, if at any time such Investor holds less than sixty percent (60%), but at least forty percent (40%), of the
Series B Preferred Stock issued to them on the Issuance Date, such Investor would only be entitled to elect one director to the Board.
Any director elected pursuant to the terms of the Certificate of Designation may be removed without cause by, and only by, the affirmative
vote of the holders of Series B Preferred Stock. A vacancy in any directorship filled by the holders of Series B Preferred Stock may
be filled only by vote or written consent in lieu of a meeting of such holders of Series B Preferred Stock or by any remaining director
or directors elected by such holders of Series B Preferred Stock .
19
Conversion
The
Certificate of Designation provides that from and after the Issuance Date and subject to the terms of the Certificate of Designation,
each share of Series B Preferred Stock is convertible, at any time and from time to time, at the option of the holder into a number of
shares of Common Stock equal to dividing the amount equal to the greater of the Stated Value of such Series B Preferred Stock, plus any
dividends declared but unpaid thereon, or such amount per share as would have been payable had each such share been converted into Common
Stock immediately prior to a liquidation, by six dollars ($ 6.00 ) (subject to adjustment in the event of any stock dividend, stock split,
combination, or other similar recapitalization affecting such shares). The aggregate number of shares of Common Stock that may be issued
through conversion of all of the New Investment Shares and Exchange Shares is 7,833,334 shares (subject to appropriate adjustment in
the event of any stock dividend, stock split, combination or other similar recapitalization affecting such shares).
Mandatory
Conversion
If
the Company consummates the sale of shares of Common Stock to the public in a firm-commitment underwritten public offering pursuant to
an effective registration statement under the Securities Act pursuant to which the price of the Common Stock in such offering is at least
equal to twelve dollars ($ 12.00 ) (subject to adjustment in the event of any stock dividend, stock split, combination, or other similar
recapitalization affecting such shares) and such offering does not include warrants (or any other convertible security) and results in
at least $ 25,000,000.00 in proceeds, net of the underwriting discount and commissions, to the Company, and the Common Stock continues
to be listed for trading on the Nasdaq Capital Market or another exchange, all outstanding shares of Series B Preferred Stock will automatically
be converted into shares of Common Stock, at the then effective Series B Conversion Ratio (as defined in the Certificate of Designation).
Liquidation
Upon
any voluntary or involuntary liquidation, dissolution or winding up of the Company or Deemed Liquidation (as defined in the Certificate
of Designation) (a “Liquidation”), the holders of shares of Series B Preferred Stock then outstanding will be entitled to
be paid out of the assets of the Company available for distribution to its stockholders (on a pari passu basis with the holders of any
class or series of preferred stock ranking on liquidation on a parity with the Series B Preferred Stock), and before any payment will
be made to the holders of Common Stock or any other class or series of preferred stock ranking on liquidation junior to the Series B
Preferred Stock by reason of their ownership thereof, an amount per share of Series B Preferred Stock equal to the greater of (i) the
Stated Value of such share of Series B Preferred Stock, plus any dividends declared but unpaid thereon, or (ii) such amount per share
as would have been payable had each such share been converted into Common Stock immediately prior to such Liquidation.
As
of March 31, 2023 and December 31, 2022, there were 47,000 Series B issued and outstanding shares of preferred stock, respectively.
17. REVOLVING LINE OF CREDIT
On
October 13, 2021, the Company and its subsidiaries entered into the Comerica Loan Agreement with Comerica, providing for a revolving
credit facility of up to $ 7,500,000 (the “Credit Facility”). The Company may use the proceeds of the Credit Facility for
working capital and other general corporate purposes.
20
The
amount that may be borrowed under the Credit Facility is the lower of (i) the revolving limit of $ 7,500,000 (the “Revolving Line”)
and (ii) 80 % of the Company’s eligible accounts receivable plus an applicable non-formula amount consisting of $ 2,000,000 of additional
availability at close not based upon the Company’s eligible accounts receivable, with such additional availability reducing by
$ 250,000 per quarter beginning with the quarter ending June 30, 2022. Borrowings on the Credit Facility are limited to $ 5,000,000 until
80 % of the Company’s and its subsidiaries’ customers are paying into a collection account or segregated governmental account
with Comerica. The Revolving Line can also include, at the Company’s option, credit card services with a sublimit of $ 300,000 .
Borrowings on the Revolving Line are subject to an interest rate equal to prime plus 0.50 %, with prime being the greater of (x) Comerica’s
stated prime rate or (y) the sum of (A) the daily adjusting LIBOR rate plus (B) 2.5 % per annum. The Company is also required to pay an
unused facility fee quarterly in arrears in an amount equal to 0.25 % per annum on the average unused but available portion of the Revolving
Line for such quarter.
The
Credit Facility matures on September 30, 2023, and is secured by a first priority lien on substantially all of the assets of the Company
and its subsidiaries. As of March 31, 2023, the balance of the revolving line was $ 2.2 million.
The
Comerica Loan Agreement contains affirmative and negative restrictive covenants that are applicable whether or not any amounts are outstanding
under the Comerica Loan Agreement. These restrictive covenants, which include restrictions on certain mergers, acquisitions, investments,
encumbrances, etc., could adversely affect our ability to conduct our business. The Comerica Loan Agreement also contains financial covenants
requiring specified minimum liquidity and minimum revenue thresholds, which the Company was in compliance with as of March 31, 2023,
and also contains customary events of default. In April 2022, Comerica waived certain covenants specifically relating to the Company
receiving financial statements with a going concern comment or qualification. In April 2022 and August 2022, Comerica waived certain
covenants specifically relating to failure to maintain bank accounts outside of Comerica in an aggregate amount not to exceed $ 0.5 million
during the transition period. Additionally, in August 2022, Comerica waived certain covenants relating to failure to segregate collections
made from government account debtors from collections made from all other account debtors and customers.
18. RECENT ACCOUNTING STANDARDS
Accounting
Pronouncements Adopted
The
FASB issued new guidance under ASC Topic 326, Financial Instruments Credit Losses. The guidance changes the allowance on accounts receivable
from an incurred method to an expected method. The Company adopted ASC Topic 326 on January 1, 2023 and it had no material effect on
the condensed consolidated financial statements.
19. SUBSEQUENT EVENTS
Termination
of Parsippany Lease
In
April 2023, the Company entered into a lease termination agreement with its Parsippany, NJ landlord terminating its lease as of April
30, 2023. The original term of the lease was through November 2023. The Company had to pay a termination fee of approximately $ 26,000 .
21
INTERPACE
BIOSCIENCES, 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 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:
●
we
have a history of operating losses and our clinical services have generated limited revenue;
●
our
expectations of future revenues, expenditures, capital or other funding requirements;
●
our
reliance on Medicare reimbursement for our clinical services and our being subject to decisions of the Center for Medicare and Medicaid
Services (“CMS”) regarding reimbursement and pricing of our clinical services which could have a material adverse effect
on our business and financial results;
●
our
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. (“Novitas”),
the Company’s Medicare administrative contractor;
●
our
secured lenders have the right to foreclose on substantially all of our assets if we are unable to timely repay our outstanding obligations;
●
our
dependence on sales and reimbursements from our clinical services for all of our revenue;
●
the
ability to continue to generate sufficient revenue from our clinical service products and other products and/or solutions that we
develop in the future is important for our ability to meet our financial and other targets;
●
our
ability to finance our business on acceptable terms in the future, which may limit the ability to grow our business, develop and
commercialize products and services, develop and commercialize new molecular clinical service solutions and technologies;
●
our
obligations to make royalty and milestone payments to our licensors;
●
our
dependence on third parties for the supply of some of the materials used in our clinical services tests;
22
●
the
potential adverse impact of current and future laws, licensing requirements and governmental regulations upon our business operations,
including but not limited to the evolving U.S. regulatory environment related to laboratory developed tests (“LDTs”),
pricing of our tests and services and patient access limitations;
●
our
reliance on our sales and marketing activities for future business growth and our ability to continue to expand our sales and marketing
activities;
●
our
being subject to the controlling interests of our two private equity investors who control, on an as-converted basis, an aggregate
of 64.5% of our outstanding shares of common stock through their holdings of our Series B Preferred Stock, and this concentration
of ownership along with their authority for designation rights for a majority of our directors and their right to approve certain
of our actions has a substantial influence on our decisions;
●
the
delisting of our common stock from Nasdaq and subsequent trading on OTCQX ® as well as the possible removal of our
common stock from trading on the OTCQX ® if we fail to meet minimum market capitalization of $5 million for ten consecutive
trading days by July 3, 2023 has adversely affected and may continue to adversely affect our common stock and business and financial
condition;
●
geopolitical
and other economic and political conditions or events (such as the war in Ukraine);
●
our
ability to implement our business strategy; and
●
the
potential impact of existing and future contingent liabilities on our financial condition.
Please
see Part I – Item 1A – “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31,
2022 filed with the SEC on March 27, 2023, and as amended on April 28, 2023, as well as other documents we file with the 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.
OVERVIEW
We
are a fully integrated commercial company that provides molecular diagnostics, bioinformatics and pathology services for evaluation of
risk of cancer by leveraging the latest technology in personalized medicine for improved patient diagnosis and management. We develop
and commercialize genomic tests and related first line assays principally focused on early detection of patients with indeterminate biopsies
and at high risk of cancer using the latest technology.
Impact
of Our Reliance on CMS and Novitas
In
January 2022, CMS stated they would no longer reimburse for the use of the Company’s ThyGeNEXT ® and ThyraMIR ®
tests when billed together by the same provider/supplier for the same beneficiary on the same date of service. However, on February
28, 2022, the Company announced that the National Correct Coding Initiative (NCCI) program issued a response on behalf of CMS stating
that the January 2022 billing policy reimbursement change for ThyGeNEXT ® (0245U) and ThyraMIR ® (0018U)
tests has been retroactively reversed to January 1, 2022. In May 2022, the Company was notified by CMS/NCCI that processing of claims
for dates of service after January 1, 2022 would be completed beginning July 1, 2022. However, on June 9, 2022, the Company was notified
that Novitas re-priced ThyGeNEXT ® (0245U) from $2,919 to $806.59 retroactively effective to January 1, 2022. On July 20,
2022, the Clinical Diagnostic Laboratory Tests (CDLT) Advisory Panel affirmed a gapfill price of $806.59. As a result of the ThyGeNEXT ®
pricing change, the Company reduced its NRV rates for ThyGeNEXT ® Medicare billing to reflect the $806.59 pricing
for tests performed during the second quarter of 2022. In addition, in order to reflect the retroactive pricing change to January 1,
2022, the Company recorded an NRV adjustment of $0.7 million during the second quarter of 2022 to reduce revenue recorded during the
first quarter of 2022. During July 2022, the Company began implementing cost-savings initiatives including a reduction in headcount and
incidental expenses and a freeze on all non-essential travel and hiring. In August 2022, the Company sold its Pharma Solutions business.
Effective January 1, 2023, the gapfill price for ThyGeNEXT ® was set at $1,266.07.
23
Further,
along with many laboratories, we may be affected by the Proposed Local Coverage Determination (“LCD”) DL39365, which was
posted on June 9, 2022 with comments extended to September 6, 2022 due to changes made to the related draft and is currently under consideration
by our local Medicare Administrative Contractor, Novitas. If finalized, this Proposed LCD, which governs “Genetic Testing for Oncology,”
could impact the existing LCD for one of our molecular tests, PancraGEN ® . If Novitas restricts coverage for PancraGEN ® ,
our liquidity could be negatively impacted beginning in Fiscal 2023.
Impact
of the ongoing military conflict between Russia and Ukraine.
In
February 2022, Russian military forces invaded Ukraine, and although the length, impact, and outcome of the ongoing war in Ukraine is
highly unpredictable, this war has led, and could continue to lead, to significant market and other disruptions, including instability
in financial markets, supply chain interruptions, political and social instability, and increases in cyberattacks, intellectual property
theft, and espionage. We are actively monitoring the situation in Ukraine and assessing its impact on our business.
We
have no way to predict the progress or outcome of the war in Ukraine or its impacts in Ukraine, Russia, or Belarus as the war, and any
resulting government reactions, are rapidly developing and beyond our control. The extent and duration of the war, sanctions, and resulting
market disruptions could be significant and could potentially have a substantial impact on the global economy and our business for an
unknown period of time. Any of the above-mentioned factors could materially adversely affect our business, financial condition, and results
of operations.
We
are also monitoring other macro-economic and geopolitical developments such as inflation and cybersecurity risks so that the Company
can be prepared to react to new developments as they arise.
Revenue
Recognition
Clinical
services derive revenues from the performance of proprietary assays or tests. Our performance obligation is fulfilled upon completion,
review and release of test results to the customer, at which time we bill third-party payers or direct-bill payers for the tests performed.
Under Accounting Standards Codification 606, revenue is recognized based upon 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.
To the extent that the transaction price includes variable consideration, for all third party and direct-bill payers and proprietary
tests, we estimate the amount of variable consideration that should be included in the transaction price using the expected value method
based on historical experience.
The
ultimate amounts received from the third-party and direct-bill payers and related estimated reimbursement rates are regularly reviewed
and we adjust the NRV’s and related contractual allowances accordingly. If actual collections and related NRV’s vary significantly
from our estimates, we adjust the estimates of contractual allowances, which affects net revenue in the period such variances become
known.
Cost
of Revenue
Cost
of revenue consists primarily of the costs associated with operating our laboratory 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, royalty expenses, and facility expenses.
24
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.
Consolidated
Results of Continuing Operations for the Quarter Ended March 31, 2023 Compared to the Quarter Ended March 31, 2022 (in thousands)
Three Months Ended March 31,
2023
2023
2022
2022
% to
% to
revenue
revenue
Revenue, net
$ 9,826
100.0 %
$ 7,923
100.0 %
Cost of revenue
3,848
39.2 %
3,265
41.2 %
Gross profit
5,978
60.8 %
4,658
58.8 %
Operating expenses:
Sales and marketing
2,342
23.8 %
2,200
27.8 %
Research and development
149
1.5 %
231
2.9 %
General and administrative
2,494
25.4 %
2,886
36.4 %
Acquisition related amortization expense
318
3.2 %
318
4.0 %
Total operating expenses
5,303
54.0 %
5,635
71.1 %
Operating income (loss)
675
6.9 %
(977 )
-12.3 %
Interest accretion expense
(35 )
-0.4 %
(121 )
-1.5 %
Note payable interest
(225 )
-2.3 %
(180 )
-2.3 %
Other income, net
19
0.2 %
161
2.0 %
Income (loss) from continuing operations before tax
434
4.4 %
(1,117 )
-14.1 %
Provision for income taxes
4
0.0 %
18
0.2 %
Income (loss) from continuing operations
430
4.4 %
(1,135 )
-14.3 %
Loss from discontinued operations, net of tax
(79 )
-0.8 %
(1,112 )
-14.0 %
Net income (loss)
$ 351
3.6 %
$ (2,247 )
-28.4 %
Revenue,
net
Revenue,
net for the three months ended March 31, 2023 increased by $1.9 million, or 24%, to $9.8 million, compared to $7.9 million for the three
months ended March 31, 2022. The increase was driven by increased test volumes as compared to the prior year.
Cost
of revenue
Cost
of revenue for the three months ended March 31, 2023 was $3.8 million, as compared to $3.3 million for the three months ended March 31,
2022. As a percentage of revenue, cost of revenue was approximately 39% for the three months ended March 31, 2023 and 41% for the three
months ended March 31, 2022. The percentage decrease was due to the increase in revenue for the quarter.
Gross
profit
Gross
profit was approximately $6.0 million for the three months ended March 31, 2023 and $4.7 million for the three months ended March 31,
2022. The gross profit percentage was approximately 61% for the three months ended March 31, 2023 and 59% for the three months ended
March 31, 2022.
25
Sales
and marketing expense
Sales
and marketing expense was approximately $2.3 million for the three months ended March 31, 2023 and $2.2 million for the three months
ended March 31, 2022. As a percentage of revenue, sales and marketing expense decreased to 24% from 28% in the comparable prior year
period due to the increase in revenue.
Research
and development
Research
and development expense was $0.1 million for the three months ended March 31, 2023 and $0.2 million for the three months ended March
31, 2022. As a percentage of revenue, research and development expense decreased to 2% from 3% in the comparable prior year period. The
decrease can be primarily attributed to the timing of projects entered into in 2023 as compared to the prior year quarter.
General
and administrative
General
and administrative expense was approximately $2.5 million for the three months ended March 31, 2023 and $2.9 million for the three months
ended March 31, 2022. The decrease can be primarily attributed to a decrease in employee compensation costs.
Acquisition
amortization expense
During
both the three months ended March 31, 2023 and March 31, 2022, we recorded amortization expense of approximately $0.3 million, respectively,
which is related to intangible assets associated with prior acquisitions.
Operating
income (loss)
Operating
income from continuing operations was $0.7 million for the three months ended March 31, 2023 as compared to an operating loss $1.0 million
for the three months ended March 31, 2022. The operating income for the three months ended March 31, 2023 can be primarily attributed
to the increase in revenue during the quarter.
Provision
for income taxes
Income
tax expense was approximately $4,000 for the three months ended March 31, 2023 and $18,000 for the three months ended March 31, 2022.
Loss
from discontinued operations, net of tax
We
had a loss from discontinued operations of approximately $0.1 million for the three months ended March 31, 2023 and a loss from discontinued
operations of approximately $1.1 million for the three months ended March 31, 2022. The loss from discontinued operations for the three
months ended March 31, 2022 included losses associated with the former Pharma Solutions unit.
Non-GAAP
Financial Measures
In
addition to the United States generally accepted accounting principles, or GAAP, results provided throughout this document, we have provided
certain non-GAAP financial measures to help evaluate the results of our performance. We believe that these non-GAAP financial measures,
when presented in conjunction with comparable GAAP financial measures, are useful to both management and investors in analyzing our ongoing
business and operating performance. We believe that providing the non-GAAP information to investors, in addition to the GAAP presentation,
allows investors to view our financial results in the way that management views financial results.
In
this Quarterly Report on Form 10-Q, we discuss Adjusted EBITDA, a non-GAAP financial measure. Adjusted EBITDA is a metric used by management
to measure cash flow of the ongoing business. Adjusted EBITDA is defined as income or loss from continuing operations, plus depreciation
and amortization, non-cash stock based compensation, interest and taxes, and other non-cash expenses including change in fair value of
notes payable and warrant liability. The table below includes a reconciliation of this non-GAAP financial measure to the most directly
comparable GAAP financial measure.
26
Reconciliation
of Adjusted EBITDA (Unaudited)
($
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 )
LIQUIDITY
AND CAPITAL RESOURCES
In
October 2021, we entered into the Comerica Loan Agreement with Comerica, providing for a revolving credit facility of up to $7,500,000
(the “Credit Facility”). The Company is using the proceeds of the Credit Facility for working capital and other general corporate
purposes.
The
amount that may be borrowed under the Credit Facility is the lower of (i) the revolving limit of $7,500,000 (the “Revolving Line”)
and (ii) 80% of the Company’s eligible accounts receivable plus an applicable non-formula amount consisting of $2,000,000 of additional
availability at close not based upon the Company’s eligible accounts receivable, with such additional availability reducing by
$250,000 per quarter beginning with the quarter ending June 30, 2022. Borrowings on the Credit Facility are limited to $5,000,000 until
80% of the Company’s and its subsidiaries’ customers are paying into a collection account or segregated governmental account
with Comerica. The Revolving Line can also include, at the Company’s option, credit card services with a sublimit of $300,000.
Borrowings on the Revolving Line are subject to an interest rate equal to prime plus 0.50%, with prime being the greater of (x) Comerica’s
stated prime rate or (y) the sum of (A) the daily adjusting LIBOR rate plus (B) 2.5% per annum. The Company is also required to pay an
unused facility fee quarterly in arrears in an amount equal to 0.25% per annum on the average unused but available portion of the Revolving
Line for such quarter. See Note 17, Revolving Line of Credit , for more details. Comerica has a first priority security interest
in substantially all of the Company’s and its subsidiaries’ assets. As of May 1, 2023 the Company owed $2.1 million on the
line of credit and had approximately $2.2 million available to borrow on the line.
In
addition, also in October 2021, the Company entered into the BroadOak Loan Agreement with BroadOak, providing for a term loan in the
aggregate principal amount of $8,000,000 (the “Term Loan”). Funding of the Term Loan took place on November 1, 2021. The
Term Loan matures upon the earlier of (i) October 31, 2024 or (ii) the occurrence of a change in control, and bears interest at the rate
of 9% per annum. The Term Loan is secured by a security interest in substantially all of the Company’s and its subsidiaries’
assets and is subordinate to the Company’s $7,500,000 revolving credit facility with Comerica Bank. The Term Loan has an origination
fee of 3% of the Term Loan amount, and a terminal payment equal to (i) 15% of the original principal amount of the Term Loan if the change
of control occurs on or prior to the first anniversary of the funding of the Term Loan, (ii) 20% of the original principal amount of
the Term Loan if the change of control occurs after the first anniversary but on or prior to the second anniversary of the funding of
the Term Loan and (iii) 30% of the original principal amount of the Term Loan if the change of control occurs after the second anniversary
of the funding of the Term Loan, or if the Term Loan is repaid on its maturity date. Upon receipt of the term loan, the proceeds were
used to repay in full at their maturity the notes extended by Ampersand and 1315 Capital discussed above. See Note 14, Notes Payable,
for more details. In May 2022, the Company issued a Convertible Note to BroadOak, pursuant to which BroadOak funded a term loan in
the aggregate principal amount of $2.0 million. See Note 14, Notes Payable , for more details.
27
The
BroadOak Loan Agreement contains affirmative and negative restrictive covenants, including restrictions on certain mergers, acquisitions,
investments and encumbrances which could adversely affect our ability to conduct our business. The BroadOak Loan Agreement also contains
customary events of default. The Comerica Loan Agreement contains affirmative and negative restrictive covenants that are applicable
whether or not any amounts are outstanding under the Comerica loan agreement. These restrictive covenants, which include restrictions
on certain mergers, acquisitions, investments, encumbrances, etc., could adversely affect our ability to conduct our business. The Comerica
Loan Agreement also contains financial covenants requiring specified minimum liquidity and minimum revenue thresholds and also contains
customary events of default. However, if we are unable to meet the financial covenants under the Comerica Loan Agreement, the revolving
line of credit and notes payable will become due and payable immediately.
In
January 2022, the Company’s registration statement for a rights offering filed with the Securities and Exchange Commission (SEC)
became effective; however, the rights offering was subsequently terminated later in January 2022 when the Company announced that the
Centers for Medicare & Medicaid Services, or CMS, issued a new billing policy whereby CMS will no longer reimburse for the use of
the Company’s ThyGeNEXT ® and ThyraMIR ® tests when billed together by the same provider/supplier for
the same beneficiary on the same date of service. On February 28, 2022, the Company announced that the National Correct Coding Initiative
(NCCI) program issued a response on behalf of CMS stating that the January 2022 billing policy reimbursement change for ThyGeNEXT ®
(0245U) and ThyraMIR ® (0018U) tests has been retroactively reversed to January 1, 2022. In May 2022, the Company
was notified by CMS/NCCI that processing of claims for dates of service after January 1, 2022 would be completed beginning July 1, 2022.
However, on June 9, 2022, the Company was notified that Novitas re-priced ThyGeNEXT ® (0245U) from $2,919 to $806.59 retroactively
effective to January 1, 2022. On July 20, 2022 the Clinical Diagnostic Laboratory Tests (CDLT) Advisory Panel affirmed a gapfill price
for ThyGeNEXT ® of $806.59. As a result of the ThyGeNEXT ® pricing change, the Company reduced its net realizable
value, or NRV rates for ThyGeNEXT ® Medicare billing to reflect the $806.59 pricing for tests performed during the second
quarter of 2022. In addition, in order to reflect the retroactive pricing change to January 1, 2022, the Company recorded an NRV adjustment
of $0.7 million during the second quarter of 2022 to reduce revenue recorded during the first quarter of 2022. Effective January 1, 2023,
the gapfill price for ThyGeNEXT ® was set at $1,266.07.
On
August 31, 2022, the Company closed on the sale of its Pharma Solutions business for a total sale price of $6.2 million after a post-closing
working capital adjustment.
For
the three months ended March 31, 2023, we had operating income from continuing operations of $0.7 million. As of the three months ended
March 31, 2023, we had cash and cash equivalents of $5.6 million, total current assets of $12.5 million and current liabilities of $13.9
million. As of May 8, 2023, we had approximately $6.7 million of cash on hand.
During
the three months ended March 31, 2023, net cash provided by operating activities was $1.1 million. The main component of cash provided
by operating activities was our net income of $0.4 million, including non-cash expenses of $0.6 million. During the three months ended
March 31, 2022, net cash used in operating activities was $1.3 million. The main component of cash used in operating activities was our
net loss of $2.2 million which was partially offset by an increase in accounts payable of $1.2 million.
For
both periods net cash used in investing activities was primarily related to the purchase of lab equipment.
For
the three months ended March 31, 2023, cash used in financing activities was $0.3 million, which were payments made on the Revolving
Line. For the three months ended March 31, 2022 , cash
provided from financing activities was $1.1 million, of which $1.0 million was from the drawdown on the Revolving Line. See Note 17 ,
Revolving Line of Credit , for more details.
We
did not generate positive cash flows from operations for the year ending December 31, 2022. We intend to meet our ongoing capital needs
by using our available cash and availability under the Comerica Loan Agreement, as well as through targeted margin improvement; collection
of accounts receivable; containment of costs; and the potential use of other financing options and other strategic alternatives. However,
if we are unable to meet the financial covenants under the Comerica Loan Agreement, the revolving line of credit and notes payable will
become due and payable immediately. The Company anticipates that current cash and cash equivalents and forecasted cash receipts will be sufficient to meet its anticipated
cash requirements through the next twelve months.
28
The
Company continues to explore various strategic alternatives, dilutive and non-dilutive sources of funding, including equity and debt
financings, strategic alliances, business development and other sources in order to provide additional liquidity. With the delisting
of our common stock from Nasdaq in February 2021 and the possible removal of our common stock from trading on the OTCQX ® if
we fail to meet minimum market capitalization of $5 million for ten consecutive trading days by July 3, 2023, our ability to raise additional
capital on terms acceptable to the Company has been adversely impacted. There can be no assurance that the Company will be successful
in obtaining such funding on terms acceptable to the Company.
Further,
along with many laboratories, we may be affected by the Proposed Local Coverage Determination (“LCD”) DL39365, which was
posted on June 9, 2022 and is currently under consideration by our local Medicare Administrative Contractor, Novitas If finalized, this
Proposed LCD, which governs “Genetic Testing for Oncology,” could impact the existing LCD for one of our molecular tests,
PancraGEN ® . If Novitas restricts coverage for PancraGEN ® , our liquidity could be negatively impacted in
the second half of Fiscal 2023.
Inflation
We
do not believe that inflation had a significant impact on our results of operations for the periods presented. However, inflation and
supply chain disruptions, whether caused by restrictions or slowdowns in shipping or logistics, increases in demand for certain goods
used in our operations, or otherwise, could impact our operations in the near term.
Critical
Accounting Estimates
See
Note 5, Summary of Significant Accounting Policies and Note 18, Recent Accounting Standards to the Interim Financial Statements
included elsewhere in this Quarterly Report on Form 10-Q for information regarding newly adopted and recent accounting pronouncements.
See also Note 1, Nature of Business and Significant Accounting Policies to our financial statements included in our Annual Report on
Form 10-K for the year ended December 31, 2022, as amended, for a discussion of our critical accounting policies. There have been no
material changes to such critical accounting policies. We believe our most critical accounting policies include accounting for contingent
consideration, revenue recognition, intangible and long-lived assets, research and development expenses and stock-based compensation
expense.
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 Principal 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 Principal 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 Exchange
Act the Chief Executive Officer of the Company and the Principal Financial Officer of the Company have concluded that the Company’s
disclosure controls and procedures were effective as of March 31, 2023.
Reference
should be made to our Form 10-K for the year ended December 31, 2022 filed with the SEC on March 27, 2023, as amended, 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.
29
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings
None.
Item
1A. Risk Factors
Not
applicable as we are a smaller reporting company.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item
3. Defaults Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
None.
Item
5. Other Information
None.
Item
6. Exhibits
Exhibit
No.
Description
31.1*
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1+
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2+
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS
Inline
XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded
within the Inline XBRL document.
101.SCH
Inline
XBRL Taxonomy Extension Schema Document.
101.CAL
Inline
XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF
Inline
XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB
Inline
XBRL Taxonomy Extension Label Linkbase Document.
101.PRE
Inline
XBRL Taxonomy Extension Presentation Linkbase Document.
104
Cover
Page Interactive Data File (formatted as Inline XBRL and contained in Exhibits 101).
+
Exhibits
32.1 and 32.2 are being furnished herewith 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.
&
Denotes
compensatory plan, compensation arrangement or management contract.
*
The
schedules and exhibits to this Exhibit have been omitted. The Company agrees to furnish a copy of the omitted schedules and exhibits
to the Securities and Exchange Commission on a supplemental basis upon its request.
30
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:
May 12, 2023
Interpace
Biosciences, Inc.
(Registrant)
/s/
Thomas W. Burnell
Thomas
W. Burnell
President
and Chief Executive Officer
(Principal
Executive Officer)
Date:
May 12, 2023
/s/
Christopher McCarthy
Christopher
McCarthy
(Principal
Financial Officer)
31
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