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 September 30, 2021
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.)
Morris
Corporate Center 1 , Building C
300
Interpace Parkway , Parsippany , NJ 07054
(Address
of principal executive offices and zip code)
(855)
776-6419
(Registrant’s
telephone number, including area code)
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 November 5, 2021
Common
Stock, par value $0.01 per share
4,174,447
INTERPACE
BIOSICENCES, INC.
FORM
10-Q FOR PERIOD ENDED SEPTEMBER 30, 2021
TABLE
OF CONTENTS
Page
No.
PART
I - FINANCIAL INFORMATION
Item
1.
Unaudited
Interim Condensed Consolidated Financial Statements
Condensed
Consolidated Balance Sheets at September 30, 2021 (unaudited) and December 31, 2020
3
Condensed
Consolidated Statements of Operations for the three- and nine-month periods ended September 30, 2021 and 2020 (unaudited)
4
Condensed
Consolidated Statements of Stockholders’ Deficit for the three- and nine-month periods ended September 30, 2021 and 2020 (unaudited)
5
Condensed
Consolidated Statements of Cash Flows for the nine- month periods ended September 30, 2021 and 2020 (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
32
Item
4.
Controls
and Procedures
32
PART
II - OTHER INFORMATION
Item
1.
Legal
Proceedings
33
Item
1A.
Risk
Factors
33
Item
2.
Unregistered
Sales of Equity Securities and Use of Proceeds
33
Item
3.
Defaults
Upon Senior Securities
33
Item
4.
Mine
Safety Disclosures
33
Item
5.
Other
Information
33
Item
6.
Exhibits
34
Signatures
35
2
PART
I. FINANCIAL INFORMATION
INTERPACE
BIOSCIENCES, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands, except share and per share data)
September
30,
December
31,
2021
2020
(unaudited)
ASSETS
Current assets:
Cash
and cash equivalents
$ 3,180
$ 2,772
Restricted
cash
250
600
Accounts
receivable, net of allowance for doubtful accounts of $ 72 and $ 275 , respectively
6,518
8,028
Other
current assets
3,135
2,722
Total current
assets
13,083
14,122
Property and equipment, net
6,484
7,349
Other intangible assets, net
8,014
11,351
Goodwill
8,433
8,433
Operating lease right of use
assets, net
3,989
4,384
Other
long-term assets
304
42
Total
assets
$ 40,307
$ 45,681
LIABILITIES
AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts
payable
$ 2,427
$ 4,511
Accrued salary
and bonus
2,728
3,161
Notes payable
- related parties
7,872
-
Other accrued
expenses
9,043
9,795
Current
liabilities from discontinued operations
766
766
Total current
liabilities
22,836
18,233
Contingent consideration, net
of current portion
1,663
1,818
Operating lease liabilities,
net of current portion
3,152
3,540
Other
long-term liabilities
4,768
4,637
Total liabilities
32,419
28,228
Commitments and contingencies
(Note 8)
-
Preferred stock, $ .01 par value;
5,000,000 shares authorized, 47,000 Series B issued and outstanding
46,536
46,536
Stockholders’ deficit:
Common stock, $ .01 par value;
100,000,000 shares authorized; 4,194,111 and 4,075,257 shares issued, respectively; 4,174,447 and 4,055,593 shares outstanding, respectively
403
402
Additional
paid-in capital
186,052
184,404
Accumulated
deficit
( 223,330 )
( 212,116 )
Treasury
stock, at cost ( 19,664 and 19,664 shares, respectively)
( 1,773 )
( 1,773 )
Total
stockholders’ deficit
( 38,648 )
( 29,083 )
Total
liabilities, preferred stock and stockholders’ deficit
$ 40,307
$ 45,681
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)
2021
2020
2021
2020
Three
Months Ended
September 30,
Nine
Months Ended
September 30,
2021
2020
2021
2020
Revenue, net
$ 9,472
$ 8,248
$ 30,461
$ 22,752
Cost of
revenue (excluding amortization of $ 1,112 and $ 1,115 for the three months and $ 3,336 and $ 3,346 for the nine months, respectively)
5,848
5,194
16,965
15,156
Gross
profit
3,624
3,054
13,496
7,596
Operating expenses:
Sales and
marketing
2,456
2,699
7,585
6,776
Research
and development
416
763
1,475
2,123
General and
administrative
3,278
3,795
9,582
12,683
Transition
expenses
363
687
2,474
798
Gain on DiamiR
transaction
-
-
( 235 )
-
Acquisition
related amortization expense
1,112
1,115
3,336
3,346
Total
operating expenses
7,625
9,059
24,217
25,726
Operating
loss
( 4,001 )
( 6,005 )
( 10,721 )
( 18,130 )
Interest accretion expense
( 106 )
( 138 )
( 375 )
( 414 )
Related party interest
( 151 )
-
( 372 )
-
Other
income (expense), net
45
( 12 )
( 255 )
473
Loss from
continuing operations before tax
( 4,213 )
( 6,155 )
( 11,723 )
( 18,071 )
(Benefit)
provision for income taxes
( 714 )
14
( 684 )
43
Loss from
continuing operations
( 3,499 )
( 6,169 )
( 11,039 )
( 18,114 )
Loss from
discontinued operations, net of tax
( 62 )
( 65 )
( 175 )
( 194 )
Net
loss
( 3,561 )
( 6,234 )
( 11,214 )
( 18,308 )
Less adjustment
for preferred stock deemed dividend
-
-
-
( 3,033 )
Net
loss attributable to common stockholders
$ ( 3,561 )
$ ( 6,234 )
$ ( 11,214 )
$ ( 21,341 )
Basic and diluted loss per share
of common stock:
From continuing
operations
$ ( 0.84 )
$ ( 1.53 )
$ ( 2.68 )
$ ( 5.25 )
From
discontinued operations
( 0.01 )
( 0.01 )
( 0.04 )
( 0.05 )
Net
loss per basic and diluted share of common stock
$ ( 0.85 )
$ ( 1.54 )
$ ( 2.72 )
$ ( 5.30 )
Weighted average number of common shares and common share
equivalents outstanding:
Basic
4,165
4,038
4,119
4,025
Diluted
4,165
4,038
4,119
4,025
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
For
The Three and
Nine Months Ended
For
The Three and
Nine Months Ended
September
30, 2021
September
30, 2020
Shares
Amount
Shares
Amount
Common stock:
Balance at January 1
4,075
$ 402
3,932
$ 393
Common stock
issued
9
-
37
1
Restricted
stock issued
12
-
6
-
Common stock
issued through market sales
-
-
80
8
Common
stock issued through ESPP
36
-
-
-
Treasury
stock purchased
Treasury stock purchased ,shares
Extinguishment of Series A Shares
Beneficial Conversion Feature in connection with Series B Issuance
Amortization of Beneficial Conversion Feature
Stock-based compensation expense
Net loss
Balance at March 31
4,132
402
4,055
402
Common
stock issued
10
-
-
-
Balance at June 30
4,142
402
4,055
402
Common stock
issued
13
-
5
-
Common
stock issued through ESPP
39
1
-
-
Balance at September 30
4,194
403
4,060
402
Treasury stock:
Balance at January 1
20
( 1,773 )
12
( 1,721 )
Treasury
stock purchased
-
-
-
-
Balance at March 31
20
( 1,773 )
12
( 1,721 )
Treasury
stock purchased
-
-
7
( 49 )
Balance at June 30
20
( 1,773 )
19
( 1,770 )
Treasury
stock purchased
-
-
-
-
Balance at September 30
20
( 1,773 )
19
( 1,770 )
Additional
paid-in capital:
Balance at January 1
184,404
182,514
Extinguishment of Series A
Shares
-
( 828 )
Beneficial
Conversion Feature in connection with Series B Issuance
-
2,205
Amortization
of Beneficial Conversion Feature
-
( 2,205 )
Common stock
issued
108
-
Common stock
issued through market sales
-
476
Stock-based
compensation expense
286
418
Balance at March 31
184,798
182,580
Stock-based
compensation expense
551
400
Balance at June 30
185,349
182,980
Common stock
issued
226
-
Stock-based
compensation expense
477
563
Balance at September 30
186,052
183,543
Accumulated
deficit:
Balance at January 1
( 212,116 )
( 185,665 )
Net
loss
( 4,207 )
( 6,494 )
Balance at March 31
( 216,323 )
( 192,159 )
Net
loss
( 3,446 )
( 5,580 )
Balance at June 30
( 219,769 )
( 197,739 )
Net
loss
( 3,561 )
( 6,234 )
Balance at September 30
( 223,330 )
( 203,973 )
Balance at January 1
( 29,083 )
-
Stock-based compensation expense
-
-
Balance at March 31
-
-
Stock-based compensation expense
-
-
Balance at June 30
-
-
Stock-based compensation expense
-
-
Total
stockholders’ deficit
$ ( 38,648 )
$ ( 21,798 )
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)
2021
2020
`
For
The Nine Months Ended September 30,
2021
2020
Cash Flows
From Operating Activities
Net loss
$ ( 11,214 )
$ ( 18,308 )
Adjustments to reconcile net
loss to net cash used in operating activities:
Depreciation
and amortization
4,350
4,102
Interest
accretion expense
375
414
Reversal
of 2019 bonus accrual
-
( 1,156 )
Bad debt
(recovery) expense
( 140 )
250
Mark to market
on warrants
137
( 62 )
Stock-based
compensation
1,228
1,354
Amortization
of deferred financing fees
110
-
Accrued interest
- Related Parties
372
-
ESPP expense
86
27
Change in
fair value of contingent consideration
( 57 )
-
Gain on DiamiR
transaction
( 235 )
-
Other gains
and expenses, net
( 2 )
-
Other changes in operating assets
and liabilities:
Decrease
in accounts receivable
1,788
1,625
Increase
in other current assets
( 413 )
( 898 )
Increase
in other long-term assets
( 14 )
-
Decrease
in accounts payable
( 2,084 )
( 1,319 )
(Decrease)
increase in accrued salaries and bonus
( 433 )
129
(Decrease)
increase in accrued liabilities
( 1,349 )
1,472
Decrease
in long-term liabilities
( 6 )
( 25 )
Net
cash used in operating activities
( 7,501 )
( 12,395 )
Cash Flows
From Investing Activities
Purchase
of property and equipment
( 192 )
( 1,275 )
Sale
of property and equipment
39
-
Net
cash used in investing activities
( 153 )
( 1,275 )
Cash Flows
From Financing Activities
Issuance
of common stock, net of expenses
335
434
Issuance
of Series B preferred stock, net of expenses
-
19,223
Loan proceeds
- related parties
7,500
-
Deferred
financing fees
( 123 )
-
Payments
on line of credit
-
( 3,000 )
Net
cash provided by financing activities
7,712
16,657
Net increase in cash, cash equivalents
and restricted cash
58
2,987
Cash, cash equivalents
and restricted cash – beginning
3,372
2,321
Cash, cash equivalents
and restricted cash – ending
$ 3,430
$ 5,308
The
accompanying notes are an integral part of these condensed consolidated financial statements.
6
1.
OVERVIEW
Nature
of Business
Interpace
Biosciences, Inc. (“Interpace” or the “Company”) enables personalized medicine, offering specialized services
along the therapeutic value chain from early diagnosis and prognostic planning to targeted therapeutic applications and pharma services.
The Company 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 also provides pharmacogenomics
testing, genotyping, biorepository and other specialized services to the pharmaceutical and biotech industries. The Company advances
personalized medicine by partnering with pharmaceutical, academic, and technology leaders to effectively integrate pharmacogenomics into
their drug development and clinical trial programs.
COVID-19
pandemic
The
outbreak of the COVID-19 pandemic continues to impact a significant portion of the regions in which we operate. The continuing impact
that the COVID-19 pandemic will have on our operations, including duration, severity and scope, remains highly uncertain and cannot be
fully predicted at this time. While we believe we have generally recovered from the adverse impact that the COVID-19 pandemic had on
our business during 2020, we believe that the COVID-19 pandemic could continue to adversely impact our results of operations, cash flows
and financial condition in the future.
As
our business operations continue to be impacted by the pandemic, we continue to monitor the situation and the guidance that is being
provided by relevant federal, state and local public health authorities. We may take additional actions based upon their recommendations.
However, it is possible that we may have to make further adjustments to our operating plans in reaction to developments that are beyond
our control.
While
we do not anticipate any lab closures at this time beyond periodic, temporary work stoppages to clean and disinfect the labs, this could
change in the future based upon conditions caused by the pandemic. It is also possible that we could experience supply chain shortages
if the pandemic worsens and if one or more suppliers is unable to continue to provide us with supplies. For the foreseeable future, however,
we do not anticipate supply chain shortages of critical supplies.
We
have developed and will continue to update our contingency plans in order to mitigate pandemic-related, adverse financial impacts upon
our business.
Transition
costs
To
optimize the operations of laboratory operations within our pharma services, we transitioned activities from the Rutherford, NJ facility
to our Morrisville, NC facility. We invested several million dollars to facilitate this relocation, including but not limited to the
transfer of personnel, expansion of the Morrisville facility and validation of transferred processes. We believe that this investment
will result in a reduction in future operating costs; however, it is not certain whether we will fully realize the anticipated savings.
We have also undergone several other cost-cutting initiatives and those costs are categorized as transition expenses as well.
7
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, Interpace Pharma Solutions, Inc. 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, 2020, as filed with the Securities
& Exchange Commission (“SEC”) on April 1, 2021 and as amended on April 29, 2021 and August 20, 2021.
The
condensed Interim Financial Statements of the Company have been prepared in accordance with generally accepted accounting principles
in the United States (“GAAP”) for interim financial reporting and the instructions to Form 10-Q and Article 10 of Regulation
S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. The condensed
Interim Financial Statements include all normal recurring adjustments that, in the judgment of management, are necessary for a fair presentation
of such interim financial statements. Discontinued operations include the Company’s wholly owned subsidiaries: Group DCA, LLC,
InServe Support Solutions; and TVG, Inc. and its Commercial Services business unit which was sold on December 22, 2015. All significant
intercompany balances and transactions have been eliminated in consolidation. Operating results for the nine-month period ended September
30, 2021 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2021.
3.
LIQUIDITY
The
accompanying consolidated financial statements have been prepared on a basis that assumes that the Company will continue as a going concern
and that contemplates the continuity of operations, the realization of assets and the satisfaction of liabilities and commitments in
the normal course of business. Accordingly, the accompanying consolidated financial statements do not include any adjustments relating
to the recoverability and classification of recorded asset amounts or amounts of liabilities that might result from the outcome of this
uncertainty.
As
of September 30, 2021, the Company had cash and cash equivalents, net of restricted cash of $ 3.2
million, net accounts receivable
of $ 6.5 million,
total current assets, net of restricted cash of $ 12.8
million and total current liabilities
of $ 22.8 million.
For the nine month period ended September 30, 2021, the Company had a net loss of $ 11.2
million and cash used in operating
activities was $ 7.5
million. As of November 5, 2021
we had approximately $ 2.4
million of cash on hand, net
of restricted cash.
The
Company has and may continue to delay, scale-back, or eliminate certain of its activities and other aspects of its operations until such
time as the Company is successful in securing additional funding. The Company is exploring various dilutive and non-dilutive sources
of funding, including equity and debt financings, strategic alliances, business development and other sources.
The
delisting from Nasdaq of our common stock which is now quoted for trading on OTCQX and the Company’s resulting inability to use
Form S-3 for offerings by it may each have an adverse impact on our ability to raise additional capital. The quotation of our common
stock on OTCQX may provide significantly less liquidity than when our stock was listed on Nasdaq and we may experience greater difficulty
in raising capital through the public or private sale of equity securities. The future success of the Company is dependent upon its ability
to obtain additional funding. There can be no assurance, however, that the Company will be successful in obtaining such funding in sufficient
amounts, on terms acceptable to the Company, or at all. In October 2021, the Company entered into a $7.5 million revolving credit facility
with Comerica Bank (“Comerica Loan Agreement”). In addition, also in October 2021, the Company entered into a new $8.0 million
term loan with BroadOak Fund V, L.P. (“BroadOak”) (“BroadOak Term Loan”), the proceeds of which were used
to repay in full at their maturity the notes extended by Ampersand 2018 Limited Partnership (“Ampersand”) and 1315 Capital
II, L.P. (“1315 Capital”). See Note 20, Subsequent Events for more details. As of the date of this Report,
the Company currently anticipates that current cash and cash equivalents will be sufficient to meet its anticipated operating cash requirements
through the end of fiscal 2022.
8
4.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Accounting
Estimates
The
preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions
that affect the amounts of assets and liabilities reported and disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the reporting period. Management’s estimates are based on historical
experience, facts and circumstances available at the time, and various other assumptions that are believed to be reasonable under the
circumstances. Significant estimates include accounting for valuation allowances related to deferred income taxes, contingent consideration,
allowances for doubtful accounts, revenue recognition, unrecognized tax benefits, and asset impairments involving other intangible assets.
The Company periodically reviews these matters and reflects changes in estimates in earnings as appropriate. Actual results could materially
differ from those estimates.
Revenue
Recognition
Our
clinical services derive its revenues from the performance of its 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 (“NRV”), which is determined based on historical collection rates by each payer
category for each proprietary test offered by the Company. To the extent the transaction price includes variable consideration, for all
third party and direct-bill payers and proprietary tests, the Company estimates the amount of variable consideration that should be included
in the transaction price using the expected value method based on historical experience.
For
our clinical services, 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 services, project level activities, including study setup and project management, are satisfied over the life of the contract
while performance-related obligations are satisfied at a point in time as the Company processes samples delivered by the customer. Revenues
are recognized at a point in time when the test results or other deliverables are reported to the customer.
Deferred Revenue
For our pharma services, project level
fee revenue is recognized as deferred revenue and recorded at fair value. It represents payments received in advance of services rendered
and is recognized ratably over the life of the contract.
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 receivables represent unconditional rights to consideration and are generated using its clinical services and
pharma 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. Pharma services represent, primarily, the performance of laboratory tests in support of clinical trials
for pharma services customers. The Company bills these services directly to the customer.
9
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 7, Leases .
Other
Current Assets
Other
current assets consisted of the following as of September 30, 2021 and December 31, 2020:
SCHEDULE
OF OTHER CURRENT ASSETS
September
30, 2021
December
31, 2020
(unaudited)
Lab supply inventory
$ 2,271
$ 2,052
Prepaid expenses
734
625
Other
130
45
Total
other current assets
$ 3,135
$ 2,722
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- and nine-month periods ended September 30, 2021 and 2020 is as follows:
SCHEDULE OF BASIC AND DILUTED NET LOSS PER SHARE
Three Months Ended
Nine Months Ended
September
30,
September
30,
2021
2020
2021
2020
(unaudited)
(unaudited)
Basic weighted average number of common
shares
4,165
4,038
4,119
4,025
Potential
dilutive effect of stock-based awards
-
-
-
-
Diluted weighted average number of common shares
4,165
4,038
4,119
4,025
10
The
Company’s Series B Preferred Stock, on an as converted basis of 7,833,334 shares for the three- and nine-months ended September
30, 2021, 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
Three Months Ended
Nine Months Ended
September
30,
September
30,
2021
2020
2021
2020
(unaudited)
(unaudited)
Options
684
878
684
878
Restricted stock and restricted
stock units (RSUs)
366
28
366
28
Warrants
1,405
1,405
1,405
1,405
2,455
2,311
2,455
2,311
Reclassifications
The
Company reclassified certain prior period balances to conform to the current year presentation.
5.
GOODWILL AND OTHER INTANGIBLE ASSETS
Goodwill
is attributable to the acquisition of our pharma services in July 2019. The carrying value of the intangible assets acquired was $ 15.6
million, with goodwill of approximately $ 8.3 million and identifiable intangible assets of approximately $ 7.3 million. In 2019, there
was an adjustment to goodwill of $ 0.1 million. The goodwill balance at September 30, 2021 was $ 8.4 million. The net carrying value of
the identifiable intangible assets from all acquisitions as of September 30, 2021 and December 31, 2020 are as follows:
SCHEDULE OF IDENTIFIABLE INTANGIBLE ASSETS CARRYING VALUE
As
of
September 30,
2021
As
of
December 31,
2020
Life
Carrying
Carrying
(Years)
Amount
Amount
(unaudited)
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
BioPharma acquisition:
Trademarks
10
1,600
1,600
Customer
relationships
8
5,700
5,700
CLIA Lab
2.3
609
609
Total
$ 39,251
$ 39,251
Accumulated Amortization
$ ( 31,237 )
$ ( 27,900 )
Net Carrying Value
$ 8,014
$ 11,351
Amortization
expense was approximately $ 1.1 million for both the three-month periods ended September 30, 2021 and 2020, respectively and approximately
$ 3.3 million for both the nine-month periods ended September 30, 2021 and 2020, respectively. Estimated amortization expense for the
next five years is as follows:
SCHEDULE OF FUTURE ESTIMATED AMORTIZATION EXPENSE
2021
2022
2023
2024
2025
$ 1,112
$ 2,155
$ 2,099
$ 873
$ 873
11
The
following table displays a roll forward of the carrying amount of goodwill from December 31, 2020 to September 30, 2021:
SCHEDULE OF GOODWILL CARRYING VALUE
Carrying
Amount
Balance as of December 31, 2020
$ 8,433
Adjustments
-
Balance as of September
30, 2021
$ 8,433
6.
FAIR
VALUE MEASUREMENTS
Cash
and cash equivalents, accounts receivable and accounts payable approximate fair value due to their relative short-term nature. The Company’s
financial liabilities reflected at fair value in the condensed consolidated financial statements include contingent consideration and
warrant liability. Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction
between market participants at the measurement date. In determining fair value, the Company uses various methods including 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.
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 September 30, 2021
Fair
Value Measurements
Carrying
Fair
As
of September 30, 2021
Amount
Value
Level
1
Level
2
Level
3
(unaudited)
Liabilities:
Contingent consideration:
Asuragen
(1)
$ 2,136
$ 2,136
$ -
$ -
$ 2,136
Other long-term liabilities:
Warrant
liability (2)
158
158
-
-
158
$ 2,294
$ 2,294
$ -
$ -
$ 2,294
As
of December 31, 2020
Fair
Value Measurements
Carrying
Fair
As
of December 31, 2020
Amount
Value
Level
1
Level
2
Level
3
Liabilities:
Contingent consideration:
Asuragen
(1)
$ 2,216
$ 2,216
$ -
$ -
$ 2,216
Other long-term liabilities:
Warrant
liability (2)
21
21
-
-
21
$ 2,237
$ 2,237
$ -
$ -
$ 2,237
(1)(2)
See Note 9, Accrued Expenses and Long-Term Liabilities
(1)
See Note 9, Accrued Expenses and Long-Term Liabilities
(2)
See Note 9, Accrued Expenses and Long-Term Liabilities
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.
12
A
roll forward of the carrying value of the Contingent Consideration Liability and the 2017 Underwriters’ Warrants to September 30,
2021 is as follows:
SCHEDULE OF FAIR VALUE, ASSETS MEASURED ON RECURRING BASIS, UNOBSERVABLE INPUT RECONCILIATION
Cancellation
of
Obligation/
Adjustment
to Fair Value/
December
31, 2020
Payments
Accretion
Conversions
Exercises
Mark
to Market
September
30,
2021
(unaudited)
Contingent consideration
liability
$ 2,216
$ ( 398 )
$ 375
$ -
$ ( 57 )
$ 2,136
Underwriters
Warrants
21
-
-
-
137
158
$ 2,237
$ ( 398 )
$ 375
$ -
$ 80
$ 2,294
Certain
of the Company’s non-financial assets, such as other intangible assets and goodwill, 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.
7.
LEASES
Finance
lease assets are included in fixed assets, net of accumulated depreciation.
The
table below presents the lease-related assets and liabilities recorded in the Condensed Consolidated Balance Sheet:
SCHEDULE
OF FINANCING AND OPERATING LEASES
Classification
on the Balance Sheet
September
30,
2021
December
31,
2020
(unaudited)
Assets
Financing lease assets
Property and equipment,
net
$ 652
$ 597
Operating
lease assets
Operating
lease right of use assets
3,989
4,384
Total
lease assets
$ 4,641
$ 4,981
Liabilities
Current
Financing
lease liabilities
Other accrued expenses
$ 98
$ 177
Operating
lease liabilities
Other
accrued expenses
1,030
1,027
Total current
lease liabilities
$ 1,128
$ 1,204
Noncurrent
Financing
lease liabilities
Other long-term liabilities
75
138
Operating
lease liabilities
Operating
lease liabilities, net of current portion
3,152
3,540
Total
long-term lease liabilities
3,227
3,678
Total
lease liabilities
$ 4,355
$ 4,882
13
The
weighted average remaining lease term for the Company’s operating leases was 6.6 years as of September 30, 2021 and 7.1 years as
of December 31, 2020 and the weighted average discount rate for those leases was 6.4 % and 6.0 % as of September 30, 2021 and December
31, 2020, respectively. The Company’s operating lease expenses are recorded within “Cost of revenue” and “General
and administrative expenses.”
The
table below reconciles the cash flows to the lease liabilities recorded on the Company’s Condensed Consolidated Balance Sheet as
of September 30, 2021:
SCHEDULE
OF MATURITIES OF OPERATING AND FINANCING LEASE LIABILITIES
Operating
Leases
Financing
Leases
2021 (remaining
through December 31)
312
39
2022
1,192
86
2023
794
60
2024
473
-
2025
402
-
2026
414
-
Thereafter
1,510
-
Total minimum lease
payments
5,097
185
Less:
amount of lease payments representing effects of discounting
915
12
Present value of future
minimum lease payments
4,182
173
Less:
current obligations under leases
1,030
98
Long-term
lease obligations
$ 3,152
$ 75
As
of September 30, 2021, contractual obligations with terms exceeding one year and estimated minimum future rental payments required by
non-cancelable operating leases with initial or remaining lease terms exceeding one year were as follows:
SCHEDULE
OF FUTURE MINIMUM LEASE PAYMENTS UNDER NON-CANCELABLE LEASES
Less than
1 to 3
3 to 5
After
Total
1 Year
Years
Years
5 Years
Operating lease obligations
$ 5,097
$ 312
$ 1,986
$ 875
$ 1,924
Total
$ 5,097
$ 312
$ 1,986
$ 875
$ 1,924
8.
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 currently 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.
14
9.
ACCRUED
EXPENSES AND LONG-TERM LIABILITIES
Other
accrued expenses consisted of the following as of September 30, 2021 and December 31, 2020:
SCHEDULE
OF OTHER ACCRUED EXPENSES
September
30, 2021
December
31, 2020
(unaudited)
Accrued royalties
$ 3,572
$ 2,710
Upfront Medicare payment
-
2,066
Operating lease liabilities
1,030
1,027
All others
1,056
1,182
Accrued professional fees
931
854
Unclaimed property
565
565
Contingent consideration
473
398
Accrued pharma services invoices
438
108
Taxes payable
248
334
Accrued lab costs - diagnostics
514
161
Financing lease liabilities
98
177
ESPP payable
37
108
Accrued sales and marketing -
diagnostics
41
51
Deferred
revenue
40
54
Total
other accrued expenses
$ 9,043
$ 9,795
Long-term
liabilities consisted of the following as of September 30, 2021 and December 31, 2020:
SCHEDULE OF LONG TERM LIABILITIES
September
30, 2021
December
31, 2020
(unaudited)
Uncertain tax positions
$ 4,517
$ 4,342
Warrant liability
158
21
Financing lease liabilities
75
138
Deferred
revenue
18
136
Total
other long-term liabilities
$ 4,768
$ 4,637
10.
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 nine-month periods ended September 30, 2021 and 2020.
SCHEDULE OF FAIR VALUE ASSUMPTIONS OF STOCK OPTIONS
September
30, 2021
September
30, 2020
(unaudited)
Risk-free interest
rate
0.78 %
0.79 %
Expected life
6.0
years
6.6
years
Expected volatility
134.79 %
122.24 %
Dividend yield
-
-
15
During
March 2021, the Company granted 312,500 stock options with an exercise price of $ 6.00 and 152,500 RSUs. The market value of the Company’s
common stock was $ 5.00 at the grant date of these awards. The Company recognized approximately $ 0.5 million and $ 0.6 million of stock-based
compensation expense during the three-month periods ended September 30, 2021 and 2020, respectively and approximately $ 1.3 million and
$ 1.4 million of stock-based compensation expense during the nine-month periods ended September 30, 2021 and 2020, respectively. The following
table has a breakout of stock-based compensation expense by line item.
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE
Three Months Ended
Nine Months Ended
September
30,
September
30,
2021
2020
2021
2020
(unaudited)
(unaudited)
Cost of revenue
$ 52
$ 60
$ 154
$ 187
Sales and marketing
76
39
201
136
Research and development
24
30
83
99
General
and administrative*
325
434
876
959
Total
stock compensation expense
$ 477
$ 563
$ 1,314
$ 1,381
*
Includes ESPP expense
11.
INCOME
TAXES
Generally,
accounting standards require companies to provide for income taxes each quarter based on their estimate of the effective tax rate for
the full year. The authoritative guidance for accounting for income taxes allows use of the discrete method when it provides a better
estimate of income tax expense. Due to the Company’s valuation allowance position, it is the Company’s position that the
discrete method provides a more accurate estimate of income tax expense and therefore income tax expense for the current quarter has
been presented using the discrete method. As the year progresses, the Company refines its estimate based on the facts and circumstances
by each tax jurisdiction. The following table summarizes income tax expense on loss from continuing operations and the effective tax
rate for three- and nine-month periods ended September 30, 2021 and 2020:
SCHEDULE
OF EFFECTIVE INCOME TAX RATE
Three Months Ended
Nine Months Ended
September
30,
September
30,
2021
2020
2021
2020
(unaudited)
(unaudited)
(Benefit) provision
for income tax
$ ( 714 )
$ 14
$ ( 684 )
$ 43
Effective income tax rate
16.9 %
0.2 %
5.8 %
0.2 %
The
Company participated in the State of New Jersey’s Technology Business Tax Certificate Transfer Program (the “Program”)
sponsored by The New Jersey Economic Development Authority. The Program enables approved biotechnology companies with unused net operating
losses (NOLs) and unused research and development credits to sell these benefits for at least 80% of the value of the tax benefits to
unaffiliated, profitable corporate taxpayers in the State of New Jersey. The Program is administered by The New Jersey Economic Development
Authority and the New Jersey Department of the Treasury’s Division of Taxation. In July 2021, the Company completed the sale of
NOLs totaling approximately $0.7 million. This amount is a current state tax benefit and is reflected in the statement of operations
for the three- and nine-months ended September 30, 2021. Income tax expense for both the three- and nine-month periods ended September
30, 2020 was primarily due to minimum state and local taxes.
12.
SEGMENT
INFORMATION
We
operate under one segment which is the business of developing and selling clinical and pharma services.
13.
DISCONTINUED
OPERATIONS
The
components of liabilities classified as discontinued operations consist of the following as of September 30, 2021 and December 31, 2020:
SCHEDULE
OF DISCONTINUED OPERATIONS
September
30, 2021
December
31, 2020
(unaudited)
Accrued
liabilities
766
766
Current
liabilities from discontinued operations
766
766
Total
liabilities
$ 766
$ 766
The
table below presents the significant components of CSO, Group DCA’s, Pharmakon’s and TVG’s results included within
loss from discontinued operations, net of tax in the condensed consolidated statements of operations for the three- and nine-months ended
September 30, 2021 and 2020.
Three Months Ended
Nine Months Ended
September
30,
September
30,
2021
2020
2021
2020
(unaudited)
(unaudited)
Income from discontinued operations,
before tax
$ -
$ -
$ -
$ -
Income
tax expense
62
65
175
194
Loss from
discontinued operations, net of tax
$ ( 62 )
$ ( 65 )
$ ( 175 )
$ ( 194 )
16
14.
NOTES
PAYABLE – RELATED PARTIES
Secured
Promissory Notes
On
January 7, 2021, the Company entered into promissory notes with Ampersand, in the amount of $ 3 million, and 1315 Capital, in the amount
of $ 2 million, respectively (together, the “Notes”) and a related security agreement (the “Security Agreement”).
Ampersand
holds 28,000
shares of the Company’s Series
B Convertible Preferred Stock, which are convertible from time to time into an aggregate of 4,666,666
shares of our Common Stock, and
1315 Capital holds 19,000
shares of the Company Series B
Convertible Preferred Stock, which are convertible from time to time into an aggregate of 3,166,668
shares of our Common Stock. On
an as-converted basis, such shares would represent approximately 38.9 %
and 26.4 %
of our fully-diluted shares of Common Stock, respectively. In
addition, pursuant to the terms of the Series B Convertible Preferred Stock certificate of designation and an amended and restated investor
rights agreement among the Company and Ampersand and 1315 Capital, they each have the right to (1) approve certain of our actions, including
our borrowing of money and any public offering of securities, and (2) designate two directors to our Board of Directors; provided, that
certain of such rights held by 1315 Capital have been delegated pursuant to the related Support Agreement (See Note 16, Equity ).
As a result, the Company considers the Notes and Security Agreement to be a related party transaction.
The
rate of interest on the Notes is equal to eight percent ( 8.0 %) per annum and their maturity date was the earlier of (a) June 30, 2021
and (b) the date on which all amounts become due upon the occurrence of any event of default as defined in the Notes. No interest payments
are due on the Notes until their maturity date. All payments on the Notes are pari passu.
On
May 10, 2021, (i) the Company and Ampersand amended the Ampersand Note to increase its principal amount to $ 4.5 million, (ii) the Company
and 1315 Capital amended the 1315 Capital Note to increase its principal amount to $ 3.0 million and (iii) the Company and Ampersand amended
the Security Agreement to include the new total principal amount of the Notes of $ 7.5 million. The maturity date of the Notes remained
the earlier of June 30, 2021 and the date on which all amounts become due upon the occurrence of any event of default and the interest
rate remained 8 %, and except with respect to their respective principal amounts, the terms of the Notes and the Security Agreement were
otherwise unchanged.
On
June 24, 2021, the Company and Ampersand amended the Ampersand Note to change its maturity date to the earlier of (a) August 31, 2021
and (b) the date on which all amounts become due upon the occurrence of any event of default as defined in the Ampersand Note. On June
25, 2021, the Company and 1315 Capital amended the 1315 Capital Note to change its maturity date in a similar manner. Except with respect
to their respective maturity dates, the terms of the Notes are otherwise unchanged. The Security Agreement remains in full force and
effect, and was not amended in connection with the amendments to the Notes.
On
August 31, 2021, the Company and Ampersand amended the Ampersand Note to change its maturity date to the earlier of (a) September 30,
2021 and (b) the date on which all amounts become due upon the occurrence of any event of default as defined in the Ampersand Note. On
August 31, 2021, the Company and 1315 Capital amended the 1315 Capital Note to change its maturity date in a similar manner.
On
September 29, 2021, the Company and Ampersand amended the Ampersand Note to change its maturity date to the earlier of (a) October 31,
2021 and (b) the date on which all amounts become due upon the occurrence of any event of default as defined in the Ampersand Note. On
September 29, 2021, the Company and 1315 Capital amended the 1315 Capital Note to change its maturity date in a similar manner. Through
September 30, 2021, approximately $ 0.1 million in financing fees have been paid.
In
the case of the amendments, the Company reviewed the changes in accordance with ASC 470 and determined they should be treated as modifications.
As of September 30, 2021, the Company has incurred approximately $ 18,000
in additional deferred financing
expenses associated with the amendments.
In
connection with the Security Agreement, the Notes were secured by a first priority lien and security interest on substantially all of
the assets of the Company. In connection with entering into the Comerica Loan Agreement, the Security Agreement lien and secured interest
became subordinate to the Comerica Loan. Additionally, if a change of control of the Company occurs (as defined in the Notes) the Company
is required to make a prepayment of the Notes in an amount equal to the unpaid principal amount, all accrued and unpaid interest, and
all other amounts payable under the Notes out of the net cash proceeds received by the Company from the consummation of the transactions
related to such change of control. The Company may prepay the Notes in whole or in part at any time or from time to time without penalty
or premium by paying the principal amount to be prepaid together with accrued interest thereon to the date of prepayment. No prepaid
amount may be re-borrowed.
17
The
Notes contain certain negative covenants which prevent the Company from issuing any debt securities pursuant to which the Company issues
shares, warrants or any other convertible security in the same transaction or a series of related transactions, except that Company may
incur or enter into any capitalized and operating leases in the ordinary course of business consistent with past practice, or borrowed
money or funded debt in an amount not to exceed $4.5 million (the “Debt Threshold”) that is subordinated to the Notes on
terms acceptable to Ampersand and 1315 Capital; provided, that if the aggregate consolidated revenue recognized by the Company as reported
on Form 10-K as filed with the SEC for any fiscal year ending after January 10, 2020 exceeds $45 million, the Debt Threshold for the
following fiscal year shall increase to an amount equal to: (x) ten percent (10%); multiplied by (y) the consolidated revenue as reported
by the Company on Form 10-K as filed with the SEC for the previous fiscal year.
The
Notes were repaid in full at maturity. See Note 20, Subsequent Events .
15.
SUPPLEMENTAL
CASH FLOW INFORMATION
Supplemental
Disclosures of Non Cash Activities
(in
thousands)
SCHEDULE
OF SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
Nine
Months Ended
September
30,
2021
2020
(unaudited)
Operating
Taxes accrued for
repurchase of restricted shares
$ -
$ 49
Investing
Preferred Stock Deemed Dividend
$ -
$ 3,033
Investment in DiamiR
248
-
16.
EQUITY
Preferred
Stock Issuance: Securities Purchase and Exchange Agreement
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 as compared to a conversion price of
$ 8.00 on the Series A Preferred Stock, but did not include certain rights applicable to the Series A Preferred Stock, including a six-percent
( 6 %) dividend and a conversion price adjustment for any failure by the Company to achieve a revenue target of $ 34.0 million in 2020 related
to its clinical services or a weighted-average anti-dilution adjustment. Under the terms of the Securities Purchase and Exchange Agreement,
Ampersand also agreed to waive all dividends and weighted-average anti-dilution adjustments accrued to date on the Series A Preferred
Stock.
18
A
convertible financial instrument includes a beneficial conversion feature if its conversion price is lower than the Company’s stock
price at the commitment date. The Company determined that the sale of the Series B Preferred resulted in a beneficial conversion feature
with an intrinsic value of $ 2.2 million, which the Company recorded as a reduction to additional paid-in capital upon the sale of the
Series B Preferred stock. The Company calculated the intrinsic value of the beneficial conversion feature as the difference between the
estimated fair value of the Common Stock on January 15, 2020 of $ 6.79 per share and the effective conversion price per share of $ 6.00
multiplied by the number of shares of common stock issuable upon conversion. The Company fully amortized the beneficial conversion feature
during the three months ended March 31, 2020 in accordance with GAAP. The beneficial conversion feature resulted in an increase in the
loss attributable to common shareholders for the three months ended March 31, 2020 in the Condensed Consolidated Statement of Operations,
as it represented a deemed dividend to the preferred shareholders.
In
April 2020, the Company entered into support agreements with each of the Series B Investors, pursuant to which Ampersand and 1315 Capital,
respectively, consented to, and agreed to vote (by proxy or otherwise), all shares of Series B Preferred Stock registered in its name
or beneficially owned by it and/or over which it exercises voting control as of the date of the Support Agreement and any other shares
of Series B Preferred Stock legally or beneficially held or acquired by such Series B Investor after the date of the Support Agreement
or over which it exercises voting control, in favor of any Fundamental Action desired to be taken by the Company as determined by the
Board. For purposes of each Support Agreement, “Fundamental Action” means any action proposed to be taken by the Company
and set forth in Section 4(d)(i), 4(d)(ii), 4(d)(v), 4(d)(vi), 4(d)(viii) or 4(d)(ix) of the Certificate of Designation of Series B Preferred
Stock or Section 8.5.1.1, 8.5.1.2, 8.5.1.5, 8.5.1.6, 8.5.1.8 or 8.5.1.9 of the Amended and Restated Investor Rights Agreement. The support
agreement between the Company and Ampersand was terminated by mutual agreement on July 9, 2020; however, the support agreement entered
into with 1315 Capital remains in effect. During October 2021, Ampersand and 1315 Capital provided consent to the Company to enter into
the Comerica Loan Agreement and the BroadOak Term Loan.
17.
WARRANTS
Warrants
outstanding and warrant activity for the nine-months ended September 30, 2021 are as follows:
SCHEDULE OF WARRANTS OUTSTANDING AND WARRANTS ACTIVITY
Description
Classification
Exercise
Price
Expiration
Date
Warrants
Issued
Balance
December 31,
2020
Warrants
Cancelled/ Expired
Balance
September 30,
2021
Private Placement
Warrants, issued January 25, 2017
Equity
$ 46.90
June
2022
85,500
85,500
-
85,500
RedPath Warrants, issued March 22, 2017
Equity
$ 46.90
September
2022
10,000
10,000
-
10,000
Underwriters Warrants, issued June 21, 2017
Liability
$ 13.20
December
2022
57,500
53,500
-
53,500
Base & Overallotment Warrants,
issued June 21, 2017
Equity
$ 12.50
June
2022
1,437,500
870,214
-
870,214
Warrants issued October 12, 2017
Equity
$ 18.00
April
2022
320,000
320,000
-
320,000
Underwriters Warrants, issued January 25, 2019
Equity
$ 9.40
January
2022
65,434
65,434
-
65,434
1,975,934
1,404,648
-
1,404,648
The
weighted average exercise price of the warrants is $ 15.97 and the weighted average remaining contractual life is approximately 0.7 years.
19
18.
RECENT
ACCOUNTING PRONOUNCEMENTS
Recently
Adopted Accounting Guidance
In
December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”).
ASU 2019-12 will simplify the accounting for income taxes by removing certain exceptions to the general principles in Topic 740. The
amendments also improve consistent application of and simplify GAAP for other areas of Topic 740 by clarifying and amending existing
guidance. The amendment was effective for annual periods beginning after December 15, 2020.
The
Company adopted this pronouncement on January 1, 2021 and the impact was not material to the Company’s Consolidated Financial Statements.
In
February 2020, the FASB issued ASU 2020-02, Financial Instruments-Credit Losses (Topic 326) and Leases (Topic 842) - Amendments to SEC
Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 119 and Update to SEC Section on Effective Date Related to Accounting Standards
Update No. 2016-02, Leases (Topic 842) which amends the effective date of the original pronouncement for smaller reporting companies.
ASU 2016-13 and its amendments will be effective for the Company for interim and annual periods in fiscal years beginning after December
15, 2022. The Company believes the adoption will modify the way the Company analyzes financial instruments, but it does not anticipate
a material impact on results of operations. The Company is in the process of determining the effects adoption will have on its consolidated
financial statements.
In
August 2020, the FASB issued ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging
– Contracts in Entity’s Own Equity (Subtopic 815 – 40), (“ASU 2020-06”). ASU 2020-06 simplifies the accounting
for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on
an entity’s own equity. The ASU2020-06 amendments are effective for fiscal years beginning after December 15, 2023, and interim
periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including
interim periods within those fiscal years. The Company does not expect this will have any impact on its unaudited consolidated financial
statements.
19.
TRANSITION EXPENSES
These expenses are primarily
related to the Rutherford, NJ lab closing and subsequent move to North Carolina, as well as other cost-saving initiatives, primarily
reductions in headcount as well as certain lergal expenses. The following is a roll forward of the transition expenses
liabilities:
Schedule
of Transition Expenses
1
2
3
4
Facilities/
Personnel
Infrastructure
Legal
Total
(unaudited)
Balance at December 31, 2020
$ 885
$ 269
$ -
$ 1,154
Transition expenses
1,044
925
505
2,474
Payments
( 1,929 )
( 1,164 )
( 269 )
( 3,362 )
Balance at September 30, 2021
$ -
$ 30
$ 236
$ 266
20.
SUBSEQUENT EVENTS
Revolving
Line of Credit
On
October 13, 2021, the Company and its subsidiaries entered into a Loan and Security Agreement (the “Comerica Loan Agreement”)
with Comerica Bank (“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.
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.
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 could adversely affect our ability to conduct our business. The Comerica
Loan Agreement also contains customary events of default.
As
a condition for Comerica to extend the Credit Facility to the Company and its subsidiaries, the Company’s existing creditors, Ampersand and 1315 Capital (the “Existing Creditors”), entered into that certain Subordination Agreement,
dated as of October 13, 2021, pursuant to which each Existing Creditor agreed to subordinate all of the indebtedness and obligations
of the Company and its subsidiaries owing to such Existing Creditor to all of the indebtedness and obligations of the Company and its
subsidiaries owing to Comerica (the “Subordination Agreement”). Each Existing Creditor 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 Subordination Agreement provides that it is solely for the benefit of Comerica and each of the Existing
Creditors and is not for the benefit of the Company or any of its subsidiaries.
20
BroadOak
Loan and Repayment of Promissory Notes
On
October 29, 2021, the Company and its subsidiaries entered into a Loan and Security Agreement (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 Company used the proceeds of the Term Loan to repay in full
at their maturity all outstanding indebtedness under the promissory notes with Ampersand,
dated January 7, 2021 and as last amended on September 29, 2021, in the amount of $ 4.5 million, and 1315 Capital, dated January 7, 2021 and as last amended on September 29, 2021, in the amount of $ 3 million, respectively. The Company,
Ampersand, and 1315 Capital also terminated a related security agreement.
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 recently established $ 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.
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 could adversely affect our ability to conduct our business. The BroadOak Loan Agreement also
contains customary events of default.
The
representations, warranties and covenants contained in the BroadOak Loan Agreement were made only for purposes of such agreement and
as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by
the contracting parties, including being qualified by confidential disclosures exchanged between the parties in connection with the execution
of such agreement. The representations and warranties may have been made for the purposes of allocating contractual risk between the
parties to such agreement instead of establishing these matters as facts, and may be subject to standards of materiality applicable to
the contracting parties that differ from those applicable to investors. Investors are not third-party beneficiaries under such agreement
and should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state
of facts or condition of the Company or any of its subsidiaries or affiliates. Moreover, information concerning the subject matter of
the representations and warranties may change after the date of such agreement, and this subsequent information may or may not be fully
reflected in the Company’s public disclosure.
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.
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
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:
●
potential
future material adverse impact of Coronavirus (COVID-19) pandemic;
●
the
quotation of our common stock on the OTCQX and our inability to use Form S-3 for offerings by the Company may adversely affect our
ability to raise additional capital;
●
our
expectations of future revenues, expenditures, capital or other funding requirements;
●
the
operating performance of our clinical services and pharma solutions businesses;
●
we
generally depend on sales and reimbursements from our clinical services for more than 50% of our revenue; the ability to continue
to generate sufficient revenue from these 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
revenue recognition is based, in part, on our estimates for future collections and such estimates may prove to be incorrect;
●
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 and expand
our pharma services offerings;
●
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 and pharma services tests;
●
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;
22
●
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
ability to implement our business and restructuring 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 Form 10-K for the fiscal year ended December 31, 2020 filed with
the SEC on April 1, 2021, as amended, 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 an emerging leader in enabling precision medicine principally in oncology by offering specialized services along the therapeutic
value chain from early diagnosis and prognostic planning to targeted therapeutic applications through our clinical and pharma services.
Through our clinical services, we enable physicians to personalize the clinical management of each individual patient by providing genomic
information to better diagnose, monitor and inform cancer treatment. Our clinical services provide clinically useful molecular diagnostic
tests, bioinformatics and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine
for improved patient diagnosis and management. Through our pharma services, we develop, commercialize and provide molecular- and biomarker-based
tests and services and provide companies with customized solutions for patient stratification and treatment selection through an extensive
suite of molecular and biomarker-based testing services, DNA- and RNA- extraction and customized assay development and trial design consultation.
Our pharma services provide pharmacogenomics testing, genotyping, biorepository and other specialized services to the pharmaceutical
and biotech industries and advance personalized medicine by partnering with pharmaceutical, academic and technology leaders to effectively
integrate pharmacogenomics into drug development and clinical trial programs with the goals of delivering safer, more effective drugs
to market more quickly, and improving patient care.
COVID-19
pandemic
The
outbreak of the COVID-19 pandemic continues to impact a significant portion of the regions in which we operate. The continuing impact
that the COVID-19 pandemic will have on our operations, including duration, severity and scope, remains highly uncertain and cannot be
fully predicted at this time. While we believe we have generally recovered from the adverse impact that the COVID-19 pandemic had on
our business during 2020, we believe that the COVID-19 pandemic could continue to adversely impact our results of operations, cash flows
and financial condition in the future.
As
our business operations continue to be impacted by the pandemic, we continue to monitor the situation and the guidance that is being
provided by relevant federal, state and local public health authorities. We may take additional actions based upon their recommendations.
However, it is possible that we may have to make further adjustments to our operating plans in reaction to developments that are beyond
our control.
While
we do not anticipate any lab closures at this time beyond periodic, temporary work stoppages to clean and disinfect the labs, this could
change in the future based upon conditions caused by the pandemic. It is also possible that we could experience supply chain shortages
if the pandemic worsens and if one or more suppliers is unable to continue to provide us with supplies. For the foreseeable future, however,
we do not anticipate supply chain shortages of critical supplies.
We
have developed and will continue to update our contingency plans in order to mitigate pandemic-related, adverse financial impacts upon
our business.
23
Transition
costs
To
optimize the operations of laboratory operations within our pharma services, we transitioned activities from the Rutherford, NJ facility
to our Morrisville, NC facility. We invested several million dollars to facilitate this relocation, including but not limited to the
transfer of personnel, expansion of the Morrisville facility and validation of transferred processes. We believe that this investment
will result in a reduction in future operating costs; however, it is not certain whether we will fully realize the anticipated savings.
We have also undergone several other cost-cutting initiatives, primarily reductions in headcount, and those costs are categorized as
transition expenses as well.
Nasdaq
delisting
On
February 16, 2021, the Company received a delisting determination letter (the “Letter”) from the Listing Qualifications Department
(the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) stating that the Staff had determined to delist the Company’s
common stock from Nasdaq due to the Company’s failure to regain compliance with the Nasdaq Capital Market’s minimum $2,500,000
stockholders’ equity requirement for continued listing as set forth in Nasdaq Listing Rule 5550(b) (the “Rule”) and
the Company’s failure to timely execute its plan to regain compliance under the Rule.
Nasdaq
commenced with delisting the Company’s common stock from the Nasdaq Capital Market and, suspended trading in the Company’s
common stock effective at the open of business on February 25, 2021.
On
February 24, 2021, the Company was approved to have its common stock quoted on the OTCQX ® Best Market tier of the OTC
Markets Group Inc. (the “OTCQX”), an electronic quotation service operated by OTC Markets Group Inc. The trading of the Company’s
common stock commenced on OTCQX at the open of business on February 25, 2021 under the trading symbol IDXG.
Additional
Reimbursement Coverage and Price Increase During 2021
Reimbursement
progress is key for us. We have been successful to date in expanding both the scope and amount of product reimbursement for our clinical
services in 2021. Examples of our progress include:
●
In
January 2021, we announced an agreement with Blue Cross Blue Shield of Florida under which ThyGeNEXT ® and ThyraMIR ®
tests are now covered in-network services for their 5 million members.
●
In
February 2021, we announced an agreement with Blue Cross Blue Shield of Illinois that makes ThyGeNEXT ® and ThyraMIR ®
tests covered in-network services for their more than 8 million members in Illinois.
●
In
April 2021, we announced that Novitas, our Medicare Administrative Contractor, has agreed to recognize the new Proprietary Laboratory
Analysis (PLA) code that specifically identifies ThyGeNEXT ® as a distinct test from any other test or service. The
new PLA code for ThyGeNEXT ® is 0245U and the reimbursement for this code remains $2,919, representing a significant
price increase over the prior reimbursement level of $560.
24
●
In
May 2021, we announced that eviCore Healthcare (“eviCore”), a wholly owned subsidiary of Cigna, has updated their laboratory
management guidelines to include positive coverage for ThyGeNEXT ® and ThyraMIR ® . This update, which
impacts approximately 27 health plans nationwide covering 100 million lives, is effective on July 1, 2021. This means that after
the effective date, claims for ThyGeNEXT and ThyraMIR which meet eviCore’s criteria for coverage will be considered medically
necessary and processed as a covered service.
Revenue
Recognition
Clinical
services derive its revenues from the performance of its 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.
With
respect to our pharma services, customer performance obligations are satisfied at a point in time as the Company processes samples delivered
by the customer. Project level activities, including study setup and project management, are satisfied over the life of the contract.
Revenues are recognized at a point in time when the test results or other deliverables are reported to the customer.
Cost
of Revenue
Cost
of revenue consists primarily of the costs associated with operating our laboratories and other costs directly related to our tests.
Personnel costs, which constitute the largest portion of cost of services, include all labor-related costs, such as salaries, bonuses,
fringe benefits and payroll taxes for laboratory personnel. Other direct costs include, but are not limited to, laboratory supplies,
certain consulting expenses, royalty expenses, and facility expenses.
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.
25
Condensed
Consolidated Results of Continuing Operations for the Quarter Ended September 30, 2021 Compared to the Quarter Ended September 30, 2020
(unaudited, in thousands)
Three
Months Ended September 30,
2021
2021
2020
2020
Revenue, net
$ 9,472
100.0 %
$ 8,248
100.0 %
Cost of revenue
5,848
61.7 %
5,194
63.0 %
Gross profit
3,624
38.3 %
3,054
37.0 %
Operating expenses:
Sales and
marketing
2,456
25.9 %
2,699
32.7 %
Research
and development
416
4.4 %
763
9.3 %
General and
administrative
3,278
34.6 %
3,795
46.0 %
Transition
expenses
363
3.8 %
687
8.3 %
Acquisition
related amortization expense
1,112
11.7 %
1,115
13.5 %
Total
operating expenses
7,625
80.5 %
9,059
109.8 %
Operating
loss
(4,001 )
-42.2 %
(6,005 )
-72.8 %
Interest accretion expense
(106 )
-1.1 %
(138 )
-1.7 %
Related party interest
(151 )
-1.6 %
-
0.0 %
Other
income (expense), net
45
0.5 %
(12 )
-0.1 %
Loss from
continuing operations before tax
(4,213 )
-44.5 %
(6,155 )
-74.6 %
(Benefit)
provision for income taxes
(714 )
-7.5 %
14
0.2 %
Loss from
continuing operations
(3,499 )
-36.9 %
(6,169 )
-74.8 %
Loss from
discontinued operations, net of tax
(62 )
-0.7 %
(65 )
-0.8 %
Net
loss
$ (3,561 )
-37.6 %
$ (6,234 )
-75.6 %
Revenue,
net
Consolidated
revenue, net for the three months ended September 30, 2021 increased by $1.2 million, or 15%, to $9.5 million, compared to $8.2 million
for the three months ended September 30, 2020. The increase in net revenue was driven by increased reimbursement rates and increased
clinical services volume as the three months ended September 30, 2020 was impacted by the pandemic. This increase was partially offset
by a fairly significant decrease in volume within pharma services. The decrease in revenue within pharma services was approximately 47%
from the comparable prior year period.
Cost
of revenue
Consolidated
cost of revenue for the three months ended September 30, 2021 was $5.8 million, as compared to $5.2 million for the three months ended
September 30, 2020. This increase is primarily attributed to the increased volume associated with the clinical services business, partially
offset by a decrease in pharma services volume. As a percentage of revenue, cost of revenue was approximately 62% for the three months
ended September 30, 2021 and 63% for the three months ended September 30, 2020.
Gross
profit
Consolidated
gross profit was approximately $3.6 million for the three months ended September 30, 2021 and $3.1 million for the three months ended
September 30, 2020. The gross profit percentage was approximately 38% for the three months ended September 30, 3021 and 37% for the three
months ended September 30, 2020.
26
Sales
and marketing expense
Sales
and marketing expense was approximately $2.5 million for the three months ended September 30, 2021 and $2.7 million for the three months
ended September 30, 2020. As a percentage of revenue, sales and marketing expense decreased to 26% from 33% in the comparable prior year
period due to the higher revenue for the three months ended September 30, 2021 with no comparable increase in expenses.
Research
and development
Research
and development expense was $0.4 million for the three months ended September 30, 2021 and $0.8 million for the three months ended September
30, 2020 due to lower professional services costs in the quarter. As a percentage of revenue, research and development expense decreased
to 4% from 9% in the comparable prior year period.
General
and administrative
General
and administrative expense was approximately $3.3 million for the three months ended September 30, 2021 and $3.8 million for the three
months ended September 30, 2020. The decrease can be primarily attributed to the closing of the Rutherford, NJ office as well as employee
and consulting costs associated with the closure.
Transition
expense
Transition
expense was approximately $0.4 million for the three months ended September 30, 2021 and $0.7 million for the three months ended September
30, 2020. These expenses are primarily related to the Rutherford, NJ lab closing and subsequent move to North Carolina, as well as other
cost-saving initiatives, primarily reductions in headcount.
Acquisition
amortization expense
During
the three months ended September 30, 2021 and September 30, 2020, we recorded amortization expense of approximately $1.1 million, respectively
in both periods, which is related to intangible assets associated with prior acquisitions.
Operating
loss
Operating
loss from continuing operations was $4.0 million for the three months ended September 30, 2021 as compared to $6.0 million for the three
months ended September 30, 2020. The lower operating loss was primarily attributable to the increase in gross profit and lower operating
expenses discussed above.
(Benefit)
provision for income taxes
The
income tax benefit was approximately $0.7 million for the three months ended September 30, 2021 which primarily pertained to the Company’s
sale of NOLs of approximately $0.7 million under the State of New Jersey’s Technology Business Tax Certificate Transfer Program.
Income tax expense of $14,000 for the three months ended September 30, 2020 was primarily driven by minimum state and local taxes.
Loss
from discontinued operations, net of tax
We
had a loss from discontinued operations of approximately $0.1 million for the three months ended September 30, 2021 and a loss from discontinued
operations of approximately $0.1 million for the three months ended September 30, 2020. In both periods, the loss represents income tax
expense associated with our discontinued operations.
27
Condensed
Consolidated Results of Continuing Operations for the Nine Months Ended September 30, 2021 Compared to the Nine Months Ended September
30, 2020 (unaudited, in thousands)
Nine
Months Ended September 30,
2021
2021
2020
2020
Revenue, net
$ 30,461
100.0 %
$ 22,752
100.0 %
Cost of revenue
16,965
55.7 %
15,156
66.6 %
Gross profit
13,496
44.3 %
7,596
33.4 %
Operating expenses:
Sales and
marketing
7,585
24.9 %
6,776
29.8 %
Research
and development
1,475
4.8 %
2,123
9.3 %
General and
administrative
9,582
31.5 %
12,683
55.8 %
Transition
expenses
2,474
8.1 %
798
3.5 %
Gain on DiamiR
transaction
(235 )
-0.8 %
-
0.0 %
Acquisition
related amortization expense
3,336
11.0 %
3,346
14.7 %
Total
operating expenses
24,217
79.5 %
25,726
113.1 %
Operating
loss
(10,721 )
-35.2 %
(18,130 )
-79.7 %
Interest accretion expense
(375 )
-1.2 %
(414 )
-1.8 %
Related party interest
(372 )
-1.2 %
-
0.0 %
Other
(expense) income, net
(255 )
-0.8 %
473
2.1 %
Loss from
continuing operations before tax
(11,723 )
-38.5 %
(18,071 )
-79.4 %
(Benefit)
provision for income taxes
(684 )
-2.2 %
43
0.2 %
Loss from
continuing operations
(11,039 )
-36.2 %
(18,114 )
-79.6 %
Loss from
discontinued operations, net of tax
(175 )
-0.6 %
(194 )
-0.9 %
Net
loss
$ (11,214 )
-36.8 %
$ (18,308 )
-80.5 %
Revenue,
net
Consolidated
revenue, net for the nine months ended September 30, 2021 increased by $7.7 million, or 34%, to $30.5 million, compared to $22.8 million
for the nine months ended September 30, 2020. The increase in net revenue was driven by increased reimbursement rates and increased clinical
services volume as the nine months ended September 30, 2020 was impacted by the pandemic. This increase was partially offset by a fairly
significant decrease in volume within pharma services. The decrease in revenue within pharma services was approximately 31% from the
comparable prior year period.
Cost
of revenue
Consolidated
cost of revenue for the nine months ended September 30, 2021 was $17.0 million, as compared to $15.2 million for the nine months ended
September 30, 2020. This increase is primarily attributed to the increased volume associated with the clinical services business. As
a percentage of revenue, cost of revenue was approximately 56% for the nine months ended September 30, 2021 and 67% for the nine months
ended September 30, 2020.
Gross
profit
Consolidated
gross profit was approximately $13.5 million for the nine months ended September 30, 2021 and $7.6 million for the nine months ended
September 30, 2020. The gross profit percentage was approximately 44% for the nine months ended September 30, 2021 and 33% for
the nine months ended September 30, 2020. The increase can be attributed to increased reimbursement rates as well as the change in the
gross profit mix.
28
Sales
and marketing expense
Sales
and marketing expense was approximately $7.6 million for the nine months ended September 30, 2021 and $6.8 million for the nine months
ended September 30, 2020. As a percentage of revenue, sales and marketing expense decreased to 25% from 30% in the comparable prior year
period due to the higher revenue for the nine months ended September 30, 2021.
Research
and development
Research
and development expense was $1.5 million for the nine months ended September 30, 2021 and $2.1 million for the nine months ended September
30, 2020 due to lower professional services and employee costs. As a percentage of revenue, research and development expense decreased
to 5% from 9% in the comparable prior year period.
General
and administrative
General
and administrative expense was approximately $9.6 million for the nine months ended September 30, 2021 and $12.7 million for the nine
months ended September 30, 2020. The decrease can be primarily attributed to the closing of the Rutherford, NJ office as well as employee
and consulting costs associated with the closure.
Transition
expense
Transition
expense was approximately $2.5 million for the nine months ended September 30, 2021 and $0.8 million for the nine months ended September
30, 2020. These expenses are primarily related to the Rutherford, NJ lab closing and subsequent move to North Carolina, as well as other
cost-saving initiatives, primarily reductions in headcount.
Acquisition
amortization expense
During
the nine months ended September 30, 2021 and September 30, 2020, we recorded amortization expense of approximately $3.3 million, respectively
in both periods, which is related to intangible assets associated with prior acquisitions.
Operating
loss
Operating
loss from continuing operations was $10.7 million for the nine months ended September 30, 2021 as compared to $18.1 million for the nine
months ended September 30, 2020. The lower operating loss was primarily attributable to the increase in gross profit discussed above.
(Benefit)
provision for income taxes
The
income tax benefit was approximately $0.7 million for the nine months ended September 30, 2021 and was related to the sale of NOLs discussed
above. Income tax expense of $43,000 for the nine months ended September 30, 2020 was primarily driven by minimum state and local taxes.
Loss
from discontinued operations, net of tax
We
had a loss from discontinued operations of approximately $0.2 million for the nine months ended September 30, 2021 and a loss from discontinued
operations of approximately $0.2 million for the nine months ended September 30, 2020. In both periods, the loss represents income tax
expense associated with our discontinued operations.
29
Non-GAAP
Financial Measures
In
addition to the United States generally accepted accounting principles, or GAAP, results provided throughout this document, we have provided
certain non-GAAP financial measures to help evaluate the results of our performance. We believe that these non-GAAP financial measures,
when presented in conjunction with comparable GAAP financial measures, are useful to both management and investors in analyzing our ongoing
business and operating performance. We believe that providing the non-GAAP information to investors, in addition to the GAAP presentation,
allows investors to view our financial results in the way that management views financial results.
In
this 10-Q, we discuss Adjusted EBITDA, a non-GAAP financial measure. Adjusted EBITDA is a metric used by management to measure cash flow
of the ongoing business. Adjusted EBITDA is defined as income or loss from continuing operations, plus depreciation and amortization,
acquisition related expenses, transition expenses, noncash stock based compensation, interest and taxes, and other non-cash expenses
including asset impairment costs, bad debt expense, loss on extinguishment of debt, goodwill impairment and change in fair value of contingent
consideration, and warrant liability. The table below includes a reconciliation of this non-GAAP financial measure to the most directly
comparable GAAP financial measure.
Reconciliation
of Adjusted EBITDA (Unaudited)
($
in thousands)
Three
Months Ended
Nine
Months Ended
September
30,
September
30,
2021
2020
2021
2020
Loss from continuing
operations (GAAP Basis)
$ (3,499 )
$ (6,169 )
$ (11,039 )
$ (18,114 )
Bad debt (recovery) expense
-
-
(140 )
250
Receipt of HHS stimulus grant
-
-
-
(650 )
Transition expenses
363
687
2,474
798
Legal and professional services
-
495
-
495
Depreciation and amortization
1,407
1,394
4,350
4,102
Stock-based compensation
477
563
1,314
1,381
Taxes
(714 )
14
(684 )
43
Financing interest and related
costs
174
-
482
-
Interest accretion expense
106
138
375
414
Gain on DiamiR transaction
-
-
(235 )
-
Mark to market on warrant liability
(71 )
(13 )
137
(62 )
Change
in fair value of contingent consideration
-
-
(57 )
-
Adjusted
EBITDA
$ (1,757 )
$ (2,891 )
$ (3,023 )
$ (11,343 )
LIQUIDITY
AND CAPITAL RESOURCES
For
the nine months ended September 30, 2021, we had an operating loss of $10.7 million. As of September 30, 2021, we had cash and cash equivalents
of $3.2 million, net of restricted cash, total current assets of $12.8 million, net of restricted cash and current liabilities of $22.8
million. As of November 5, 2021, we had approximately $2.4 million of cash on hand, net of restricted cash.
During
the nine months ended September 30, 2021, net cash used in operating activities was $7.5 million. The main component of cash used in
operating activities was our net loss of $11.2 million which was partially offset by non-cash expenses of $6.2 million. During the nine
months ended September 30, 2020, net cash used in operating activities was $12.4 million. The main component of cash used in operating
activities was our net loss of $18.3 million which was partially offset by non-cash expenses of $4.9 million.
During
the nine months ended September 30, 2021, net cash used in investing activities was $0.2 million. For the nine months ended September
30, 2020, cash used in investing activities was $1.3 million, primarily related to capital expenditures associated with the moving of
our Rutherford, New Jersey lab to North Carolina.
For
the nine months ended September 30, 2021, cash provided from financing activities was $7.7 million, of which $7.4 million were the net
proceeds from the Company’s secured promissory notes with Ampersand and 1315. See Note 14, Notes Payable - Related Parties of
the notes to the financial statements. For the nine months ended September 30, 2020, cash provided from financing activities was $16.7
million, $19.2 million which resulted from the issuance of preferred stock in January 2020 and $0.4 million from sales of Common Stock,
partially offset by the repayment of $3.0 million of borrowed funds under our Revolver.
In
September 2020, we repaid approximately $3.4 million to SVB under our former secured revolving line of credit facility (the “Revolver”),
which was part of our Loan and Security Agreement with SVB dated November 13, 2018, as amended March 18, 2019 (as so amended, the “SVB
Loan Agreement”). On January 5, 2021, the Company terminated the SVB Loan Agreement.
30
On
January 7, 2021, the Company entered into secured promissory notes in the amount of $3 million and $2 million with Ampersand and 1315
Capital, respectively. See Note 14, Notes Payable – Related Parties of the notes to the financial statements. On May 10,
2021, the Company amended the Ampersand Note to increase the principal amount to $4.5 million and amended the 1315 Capital Note to increase
the principal amount to $3.0 million. The maturity dates of the Notes were the earlier of (a) June 30, 2021 and (b) the date on which
all amounts become due upon the occurrence of any event of default as defined in the Notes. On June 24, 2021, the Company and Ampersand
amended the Ampersand Note to change its maturity date to the earlier of (a) August 31, 2021 and (b) the date on which all amounts become
due upon the occurrence of any event of default as defined in the Ampersand Note. On June 25, 2021, the Company and 1315 Capital amended
the 1315 Capital Note to change its maturity date in a similar manner. On August 31, 2021, the Company and Ampersand amended the Ampersand
Note to change its maturity date to the earlier of (a) September 30, 2021 and (b) the date on which all amounts become due upon the occurrence
of any event of default as defined in the Ampersand Note. On August 31, 2021, the Company and 1315 Capital amended the 1315 Capital Note
to change its maturity date in a similar manner.
On
September 29, 2021, the Company and Ampersand amended the Ampersand Note to change its maturity date to the earlier of (a) October 31,
2021 and (b) the date on which all amounts become due upon the occurrence of any event of default as defined in the Ampersand Note. On
September 29, 2021, the Company and 1315 Capital amended the 1315 Capital Note to change its maturity date in a similar manner.
In
January 2020, we sold 20,000 preferred shares to investors, led by 1315 Capital, for net proceeds of approximately $19.2 million; see
Note 16, Equity of the notes to the financial statements for more detail.
See
Note 1, Overview , of the notes to the financial statements, regarding the potential adverse impact of the COVID-19 pandemic on
our results of operations, cash flows and financial condition for fiscal 2021 and possibly beyond.
During
Fiscal 2020, the Company applied for various federal stimulus grants and advances made available under Title 1 of the Coronavirus Aid,
Relief, and Economic Security (CARES) Act (the “CARES Act”) and received $2.1 million in advances under the Centers for Medicare
& Medicaid Services (“CMS”) accelerated and advance payment program. As of September 30, 2021 the entire advance had
been repaid.
The
Company has and may continue to delay, scale-back, or eliminate certain of its activities and other aspects of its operations until such
time as the Company is successful in securing additional funding. The Company is exploring various dilutive and non-dilutive sources
of funding, including equity and debt financings, strategic alliances, business development and other sources. The future success of
the Company is dependent upon its ability to obtain additional funding. However, the quotation of our common stock on OTCQX may provide
significantly less liquidity than when our stock was listed on Nasdaq and we may experience greater difficulty in raising capital through
the public or private sale of equity securities. In addition, our inability to use Form S-3 for offerings by the Company may negatively
impact our ability to raise additional capital. There can be no assurance therefore that the Company will be successful in obtaining
such funding in sufficient amounts, on terms acceptable to the Company, or at all.
31
In
October 2021, the Company entered into a $7.5 million revolving credit facility with Comerica. In addition, also in October 2021, the
Company entered into the $8.0 million BroadOak Term Loan, the proceeds of which were used to repay in full at their maturity the notes
extended by Ampersand and 1315 Capital. See Note 20, Subsequent Events for more details. As of the date of this Report,
the Company currently anticipates that current cash and cash equivalents will be sufficient to meet its anticipated operating cash requirements
through the end of fiscal 2022.
In
October 2021, the Company entered into the Comerica Loan Agreement and the BroadOak Loan and repaid the promissory notes. See Note
20, Subsequent Events for more details.
We
will not generate positive cash flows from operations for the year ending December 31, 2021. We intend to meet our ongoing capital needs
by using our available cash and the Comerica Loan Agreement, as well as revenue growth and margin improvement; collection of accounts
receivable; containment of costs; and the potential use of other financing options.
Inflation
We
do not believe that inflation had a significant impact on our results of operations for the periods presented. On an ongoing basis, we
attempt to minimize any effects of inflation on our operating results by controlling operating costs and whenever possible, seeking to
ensure that billing rates reflect increases in costs due to inflation.
Off-Balance
Sheet Arrangements
None.
Item
3. Quantitative and Qualitative Disclosures About Market Risk
As
a smaller reporting company, we are electing scaled disclosure reporting obligations and therefore are not required to provide the information
requested by this Item.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure
controls and procedures pursuant to Rule 13a-15 under the Exchange Act as of the end of the period covered by this Form 10-Q. In designing
and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed
and operated, can provide only reasonable assurance of achieving the desired control objectives including that information we are required
to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time
periods specified in the SEC rules and forms, and that such information is accumulated and communicated to our management, including
our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In
addition, management is required to apply its judgment in evaluating the benefits of possible disclosure controls and procedures relative
to their costs to implement and maintain.
32
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 Chief Financial Officer of the Company have concluded that the Company’s
disclosure controls and procedures were effective as of September 30, 2021.
Reference
should be made to our Form 10-K filed with the SEC on April 1, 2021 for additional information regarding discussion of the effectiveness
of the Company’s controls and procedures.
Changes
in Internal Controls
During
the third quarter ended September 30, 2021 management believes that it has completed its remediation plan to address the material weakness
that existed at the end of 2020 and through the first and second quarters of 2021. Other than the completion of this remediation plan,
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.
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.
33
Item
6. E xhibits
Exhibit
No.
Description
10.1
Third Amendment to Secured Promissory Note dated August 31, 2021 with Ampersand 2018 Limited Partnership, incorporated by reference to Exhibit 99.1 of the Company’s Current Report on Form 8-K, filed with the SEC on August 31, 2021.
10.2
Third Amendment to Secured Promissory Note dated August 31, 2021 with 1315 Capital II, L.P., incorporated by reference to Exhibit 99.2 of the Company’s Current Report on Form 8-K, filed with the SEC on August 31, 2021.
10.3
Fourth Amendment to Secured Promissory Note dated September 29, 2021 with Ampersand 2018 Limited Partnership, incorporated by reference to Exhibit 99.1 of the Company’s Current Report on Form 8-K, filed with the SEC on October 1, 2021.
10.4
Fourth Amendment to Secured Promissory Note dated September 29, 2021 with 1315 Capital II, L.P., incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K, filed with the SEC on October 1, 2021.
10.5
Loan and Security Agreement by and between Comerica Bank, Interpace Biosciences, Inc., Interpace Diagnostics Corporation, Interpace Diagnostics, LLC and Interpace Pharma Solutions, Inc., dated October 13, 2021, incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed with the SEC on October 19, 2021.
10.6
Subordination Agreement by and between Ampersand 2018 Limited Partnership, 1315 Capital II. L.P., Comerica Bank Interpace Biosciences, Inc., Interpace Diagnostics Corporation, Interpace Diagnostics, LLC and Interpace Pharma Solutions, Inc., dated October 13, 2021, incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K, filed with the SEC on October 19, 2021.
10.7
Loan and Security Agreement by and between BroadOak Fund V, L.P., Interpace Biosciences, Inc., Interpace Diagnostics Corporation, Interpace Diagnostics, LLC and Interpace Pharma Solutions, Inc., dated October 29, 2021, incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed with the SEC on November 3, 2021.
10.8
First Amendment to Loan and Security Agreement by and between Comerica Bank, Interpace Biosciences, Inc., Interpace Diagnostics Corporation, Interpace Diagnostics, LLC and Interpace Pharma Solutions, Inc., dated November 1, 2021, incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K, filed with the SEC on November 3, 2021.
10.9
Subordination and Intercreditor Agreement by and between Comerica Bank, BroadOak Fund V, L.P., Interpace Biosciences, Inc., Interpace Diagnostics Corporation, Interpace Diagnostics, LLC and Interpace Pharma Solutions, Inc., dated as of November 1, 2021, incorporated by reference to Exhibit 10.3 of the Company’s Current Report on Form 8-K, filed with the SEC on November 3, 2021.
31.1
Certification
of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, filed herewith.
31.2
Certification
of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, filed herewith.
32.1+
Certification
of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002,
furnished herewith.
32.2+
Certification
of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002,
furnished herewith.
101
The
following financial information from this Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2021 formatted
in iXBRL (Inline eXtensible Business Reporting Language) and furnished electronically herewith: (i) the Condensed Consolidated Balance
Sheets; (ii) the Condensed Consolidated Statements of Operations; (iii) the Condensed Consolidated Statements of Stockholders’
Equity; (iv) the Condensed Consolidated Statements of Cash Flows; and (v) the Notes to Condensed Consolidated Financial Statements.
104
The
cover page of Interpace Biosciences, Inc.’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, formatted
in iXBRL (included within Exhibit 101 attachments).
+
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.
34
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:
November 10, 2021
Interpace
Biosciences, Inc.
(Registrant)
/s/
Thomas W. Burnell
Thomas
W. Burnell
President
and Chief Executive Officer
(Principal
Executive Officer)
Date:
November 10, 2021
/s/
Thomas Freeburg
Thomas
Freeburg
Chief
Financial Officer
(Principal
Financial Officer)
35
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.