Item 9A. Controls and Procedures
ITEM
9A.
CONTROLS
AND PROCEDURES
Disclosure
Controls and Procedures
Our
principal executive officer and principal financial officer evaluated the effectiveness of our disclosure controls and procedures as
of December 31, 2021. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and
15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, means controls and other procedures of a company
that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the
Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission’s
rules and forms. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide
only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit
relationship of possible controls and procedures. Disclosure controls and procedures include, without limitation, controls and
procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the
Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial
officers, as appropriate to allow timely decisions regarding required disclosure. Based on that evaluation, our principal executive
officer and principal financial officer concluded that our disclosure controls and procedures were effective as of the end of the period
covered by this Annual Report on Form 10-K.
80
Management’s
Annual Report on Internal Control over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal control over financial reporting as such term is defined
in Exchange Act Rule 13a-15(f). Internal control over financial reporting is a process designed under the supervision and
with the participation of our management, including our principal executive officer and principal financial officer, to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance
with accounting principles generally accepted in the United States of America. All internal control systems, no matter how well designed,
have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect
to financial statement preparation and presentation.
As
of December 31, 2021, under the supervision and with the participation of our management, including our principal executive officer
and principal financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based
on the framework in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations
of the Treadway Commission. Based on this assessment, our management concluded that, as of December 31, 2021, our internal control
over financial reporting was effective based on those criteria.
Changes
in Internal Control over Financial Reporting
There
has been no change in our internal control over financial reporting during the quarter ended December 31, 2021 that has
materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
ITEM
9B.
OTHER
INFORMATION
None.
ITEM
9C.
DISCLOSURE
REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
81
PART
III
ITEM
10.
DIRECTORS,
EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Information
relating to directors and executive officers of the registrant that is responsive to Item 10 of this Annual Report on Form 10-K will
be included in an amendment hereto or will be included in our Proxy Statement for our 2022 annual meeting of stockholders and such
information is incorporated by reference herein.
ITEM
11.
EXECUTIVE
COMPENSATION
Information
relating to executive compensation of the registrant that is responsive to Item 11 of this Annual Report on Form 10-K will be included
in an amendment hereto or will be included in our Proxy Statement for our 2022 annual meeting of stockholders, and such information
is incorporated by reference herein.
ITEM
12.
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
Information
relating to security ownership of certain beneficial owners and management of the registrant that is responsive to Item 12 of this
Annual Report on Form 10-K will be included in an amendment hereto or will be included in our Proxy Statement for our 2022 annual
meeting of stockholders and such information is incorporated by reference herein.
ITEM
13.
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
Information
relating to certain relationships and related transactions of the registrant that is responsive to Item 13 of this Annual Report
on Form 10-K will be included in an amendment hereto or will be included in our Proxy Statement for our 2022 annual meeting of stockholders
and such information is incorporated by reference herein.
ITEM
14.
PRINCIPAL
ACCOUNTING FEES AND SERVICES
Information
relating to principal accounting fees and services of the registrant that is responsive to Item 14 of this Annual Report on Form
10-K will be included in an amendment hereto or will be included in our Proxy Statement for our 2022 annual meeting of stockholders
and such information is incorporated by reference herein.
82
PART
IV
ITEM
15.
EXHIBITS,
FINANCIAL STATEMENT SCHEDULES
(a)
The
following documents are filed as part of this Form 10-K:
(1)
Financial
Statements – See Index to Financial Statements on page F-1 of this Form 10-K.
(2)
Financial
Statement Schedule
Schedule
II: Valuation and Qualifying Accounts
All
other schedules are omitted because they are not applicable or the required information is shown in the financial statements or notes
thereto.
(3)
Exhibits
Exhibit
No.
Description
2.1
Asset Purchase Agreement, dated August 13, 2014, by and between Interpace Diagnostics, LLC and Asuragen, Inc., incorporated by reference to Exhibit 2.2 of the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, filed with the SEC on November 5, 2014.
2.2
Asset Purchase Agreement, dated as of October 30, 2015, by and between Publicis Touchpoint Solutions, Inc. and PDI, Inc., incorporated by reference to Exhibit 2.1 of the Company’s Current Report on Form 8-K, filed with the SEC on November 2, 2015.
2.3
Asset Purchase Agreement by and among the Company and Diamir Biosciences Corp. dated March 16, 2021,incorporated by reference to Exhibit 2.1 of the Company’s quarterly report on Form 10-Q for the quarter ended March 31, 2021, filed with the SEC on May 11, 2021.
3.1+
Conformed version of Certificate of Incorporation of Interpace Biosciences, Inc., as amended by the Certificate of Amendment, effective January 15, 2020, and the Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock, filed January 17, 2020, incorporated by reference to Exhibit 3.1 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on April 22, 2020, as amended from time to time.
3.2
Amended and Restated Bylaws of Interpace Biosciences, Inc., incorporated by reference to Exhibit 3.2 of the Company’s Current Report on Form 8-K, filed with the SEC on November 14, 2019.
4.1
Description
of Securities, incorporated by reference to Exhibit 4.1 of the Company’s Annual Report on Form 10-K, filed with the SEC on
April 1, 2021.
4.2
Specimen Certificate Representing the Common Stock, incorporated by reference to Exhibit 4.1 of the Company’s Registration Statement on Form S-3 (File No. 333-227728), filed with the SEC on October 5, 2018.
4.3
Form of Common Stock Purchase Warrant, incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K, filed with the SEC on January 20, 2017.
4.4
Form of Common Stock Purchase Warrant, incorporated by reference to Exhibit 4.3 of the Company’s Current Report on Form 8-K, as amended, filed with the SEC on March 24, 2017.
4.5
Form of PreFunded Common Stock Purchase Warrant, incorporated by reference to Exhibit 4.2 of the Company’s Current Report on Form 8-K, filed with the SEC on June 21, 2017.
4.6
Form of Underwriters’ Warrants, incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K, filed with the SEC on June 21, 2017.
4.7
Form of Common Stock Purchase Warrant, incorporated by reference to Exhibit 4.3 of the Company’s Current Report on Form 8-K, filed with the SEC on June 21, 2017.
4.8
Form of Common Stock Purchase Warrant, incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K, filed with the SEC on October 12, 2017.
4.9
Loan and Security Agreement, dated November 13, 2018, by and among Silicon Valley Bank, Interpace Diagnostics Group, Inc., Interpace Diagnostics Corporation, and Interpace Diagnostics, LLC, incorporated by reference to Exhibit 4.9 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on April 22, 2020, as amended from time to time.
4.10
Form of Underwriter Common Stock Purchase Warrant, incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K, filed with the SEC on January 29, 2019.
4.11
Subordinated Seller Note of Interpace BioPharma, Inc., dated July 15, 2019, in favor of Cancer Genetics, Inc., incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K, filed with the SEC on July 19, 2019.
10.1*
Amended and Restated 2004 Stock Award and Incentive Plan, incorporated by reference to Annex A of the Company’s definitive proxy statement, filed with the SEC on August 14, 2017.
10.2*
Form of Restricted Stock Unit Agreement for Employees, incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, filed with the SEC on May 15, 2018.
83
Exhibit
No.
Description
10.3*
Form of Restricted Stock Unit Agreement for Directors, incorporated by reference to Exhibit 10.2 of the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, filed with the SEC on May 15, 2018.
10.4*
Form of Non-Qualified Stock Option Agreement, incorporated by reference to Exhibit 10.3 of the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, filed with the SEC on May 15, 2018.
10.5*
Form of Incentive Stock Option Agreement, incorporated by reference to Exhibit 10.4 of the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, filed with the SEC on May 15, 2018.
10.6*
Interpace Diagnostics Group, Inc. 2019 Equity Incentive Plan, incorporated by reference to Exhibit 4.1 of the Company’s quarterly report on Form 10-Q for the quarter ended September 30, 2019, filed with the SEC on November 14, 2019.
10.7*
Amendment to the Interpace Biosciences, Inc. 2019 Equity Incentive Plan, incorporated by reference to Exhibit 10.8 of the Company’s quarterly report on Form 10-Q for the quarter ended March 31, 2020, filed with the SEC on June 26, 2020.
10.8*
Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement under the 2019 Equity Incentive Plan, incorporated by reference to Exhibit 4.3 of the Company’s quarterly report on Form 10-Q for the quarter ended September 30, 2019, filed with the SEC on November 14, 2019.
10.9*
Form of Interpace Biosciences, Inc. 2019 Equity Incentive Plan Restricted Stock Unit And Restricted Stock Unit Agreement, incorporated by reference to Exhibit 10.9 of the Company’s quarterly report on Form 10-Q for the quarter ended March 31, 2020, filed with the SEC on June 26, 2020.
10.10*
Form of Stock Option Grant Notice and Stock Option Agreement under the 2019 Equity Incentive Plan, incorporated by reference to Exhibit 4.4 of the Company’s quarterly report on Form 10-Q for the quarter ended September 30, 2019, filed with the SEC on November 14, 2019.
10.11*
Interpace Diagnostics Group, Inc. Employee Stock Purchase Plan, incorporated by reference to Exhibit 4.2 of the Company’s quarterly report on Form 10-Q for the quarter ended September 30, 2019, filed with the SEC on November 14, 2019.
10.12*
Employment agreement entered into May 10, 2021, effective February 1, 2021, between Thomas Freeburg and the Company, incorporated by reference to Exhibit 10.2 of the Company’s quarterly report on Form 10-Q for the quarter ended March 31, 2021, filed with the SEC on May 11, 2021.
10.15*
Severance agreement and General Release, dated January 31, 2021, by and between the Company and Fred Knechtel, incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed with the SEC on February 4, 2021.
10.16*
Incentive Stock Option Agreement between Interpace Diagnostics Group, Inc. and Jack E. Stover, incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed with the SEC on October 20, 2016.
10.17*
Amended and Restated Employment Agreement dated December 5, 2018, between the Company and Jack E. Stover, incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed with the SEC on December 11, 2018.
10.18*
First Amendment to Amended and Restated Employment Agreement, dated January 29, 2020, by and between Interpace Biosciences, Inc. and Jack E. Stover, incorporated by reference to Exhibit 10.3 of the Company’s Current Report on Form 8-K, filed with the SEC on January 31, 2020.
10.20*
Employment Agreement, dated November 23, 2020, between Thomas W. Burnell and Interpace Biosciences, Inc., incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed with the SEC on November 25, 2020.
10.21*
Separation and Consulting Agreement and General Release, dated November 23, 2020, between Jack E. Stover and Interpace Biosciences, Inc., incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K, filed with the SEC on November 25, 2020 .
10.22*
Form of Indemnification Agreement by and between Interpace Diagnostics Group, Inc. and its directors and executive officers, incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed with the SEC on August 8, 2016.
10.23*
Form of Indemnification Agreement by and between Interpace Biosciences, Inc. and Indemnitee, incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K, filed with the SEC on January 17, 2020.
10.24
License Agreement, dated August 13, 2014, by and between Interpace Diagnostics, LLC and Asuragen, Inc., incorporated by reference to Exhibit 10.31 of the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, filed with the SEC on November 5, 2014.
84
Exhibit
No.
Description
10.25
CPRIT License Agreement, dated August 13, 2014, by and between Interpace Diagnostics, LLC and Asuragen, Inc., incorporated by reference to Exhibit 10.32 of the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, filed with the SEC on November 5, 2014.
10.26
Supply Agreement, dated August 13, 2014, by and between Interpace Diagnostics, LLC and Asuragen, Inc., incorporated by reference to Exhibit 10.33 of the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, filed with the SEC on November 5, 2014.
10.27
Guaranty, dated August 13, 2014 by the Company in favor of Asuragen, Inc., incorporated by reference to Exhibit 10.34 of the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, filed with the SEC on November 5, 2014.
10.28
Morris Corporate Center Lease, incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2009, filed with the SEC on November 5, 2009.
10.29
First Amendment to Lease, dated May 24, 2017, by and between Brookwood MC Investors, LLC, Brookwood MC II, LLC, and the Company, incorporated by reference to Exhibit 10.52 of the Company’s Registration Statement on Form S-1 (333-218140), as amended, filed with the SEC on June 13, 2017.
10.39
Lease Agreement, dated March 31, 2017, by and between Saddle Lane Realty, LLC and the Company, incorporated by reference to Exhibit 10.53 of the Company’s Registration Statement on Form S-1 (333-218140), as amended on June 13, 2017.
10.40
First Amendment, dated September 26, 2017, by and between Saddle Lane Realty, LLC and Interpace Diagnostics Corporation, incorporated by reference to Exhibit 10.36 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on April 22, 2020, as amended from time to time
10.41
Amendment No. 2 to Lease, dated March 15, 2018, between Saddle Lane Realty, LLC and Interpace Diagnostics Corporation, incorporated by reference to Exhibit 10.45 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on March 23, 2018.
10.42
Form of Securities Purchase Agreement, dated January 20, 2017, by and between Interpace Diagnostics Group, Inc. and certain purchasers named therein, incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K, filed with the SEC on January 20, 2017.
10.43
Warrant Agency Agreement, dated June 21, 2017, by and between Interpace Diagnostics Group, Inc. and American Stock Transfer & Trust Company, LLC, incorporated by reference to Exhibit 1.2 of the Company’s Current Report on Form 8-K, filed with the SEC on June 21, 2017.
85
Exhibit
No.
Description
10.44
Form of Warrant Exercise Agreement dated October 12, 2017, incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed with the SEC on October 12, 2017.
10.45
Securities Purchase Agreement, dated July 15, 2019, by and between Interpace Diagnostics Group, Inc. and Ampersand 2018 Limited Partnership, incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K, filed with the SEC on July 19, 2019.
10.46
Transition Services Agreement, dated July 15, 2019, by and between Interpace BioPharma, Inc. and Cancer Genetics, Inc., incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed with the SEC on July 19, 2019.
10.47
Form of Voting Agreement, incorporated by reference to Exhibit 10.4 of the Company’s Current Report on Form 8-K, filed with the SEC on July 19, 2019.
10.50
Consent to Assignment, dated July 19, 2019, by and among Meadows Landmark LLC, Cancer Genetics, Inc., and Interpace BioPharma, Inc, incorporated by reference to Exhibit 10.46 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on April 22, 2020, as amended from time to time.
10.51
Lease Agreement, dated June 12, 2004, by and between Southport Business Park Limited Partnership and Gentris Corporation, incorporated by reference to Exhibit 10.47 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on April 22, 2020, as amended from time to time.
10.52
Letter Amendment, dated October 21, 2004, by and between Southport Business Park Limited Partnership and Gentris Corporation, incorporated by reference to Exhibit 10.48 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on April 22, 2020, as amended from time to time.
10.53
Second Amendment to Lease, dated June 17, 2005, by and between Southport Business Park Limited Partnership and Gentris Corporation, incorporated by reference to Exhibit 10.49 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on April 22, 2020, as amended from time to time.
10.54
Third Amendment to Lease, dated May 25, 2006, by and between Southport Business Park Limited Partnership and Gentris Corporation, incorporated by reference to Exhibit 10.50 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on April 22, 2020, as amended from time to time.
10.55
Fourth Amendment to Lease, dated December 20, 2007, by and between Southport Business Park Limited Partnership and Gentris Corporation, incorporated by reference to Exhibit 10.51 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on April 22, 2020, as amended from time to time.
10.56
Fifth Amendment to Lease, dated June 15, 2009, by and between Southport Business Park Limited Partnership and Gentris Corporation, incorporated by reference to Exhibit 10.52 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on April 22, 2020, as amended from time to time.
86
Exhibit
No.
Description
10.57
Sixth Amendment to Lease, dated June 3, 2010, by and between Southport Business Park Limited Partnership and Gentris Corporation, incorporated by reference to Exhibit 10.53 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on April 22, 2020, as amended from time to time.
10.58
Seventh Amendment to Lease, dated October 26, 2010, by and between Southport Business Park Limited Partnership and Gentris Corporation, incorporated by reference to Exhibit 10.54 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on April 22, 2020, as amended from time to time.
10.59
Eighth Amendment to Lease, dated July 27, 2011, by and between Southport Business Park Limited Partnership and Gentris Corporation, incorporated by reference to Exhibit 10.55 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on April 22, 2020, as amended from time to time.
10.60
Ninth Amendment to Lease, dated November 7, 2012, by and between Southport Business Park Limited Partnership and Gentris Corporation, incorporated by reference to Exhibit 10.56 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on April 22, 2020, as amended from time to time.
10.61
Tenth Amendment to Lease, dated July 15, 2014, by and among Southport Business Park Limited Partnership, Gentris Corporation, and Gentris, LLC, incorporated by reference to Exhibit 10.57 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on April 22, 2020, as amended from time to time.
10.62
Eleventh Amendment to Lease, effective as of June 1, 2020, by and between Southport Business Park Limited Partnership and Interpace Pharma Solutions, Inc., incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed with the SEC on June 9, 2020.
10.63
Assignment of Lease, dated July 15, 2019, by and between Cancer Genetics, Inc. and Interpace BioPharma, Inc., incorporated by reference to Exhibit 10.58 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on April 22, 2020, as amended from time to time.
10.64
Guaranty of Lease, dated July 15, 2019, by and between Interpace Diagnostics Group, Inc. and Southport Business Park Limited Partnership, incorporated by reference to Exhibit 10.59 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on April 22, 2020, as amended from time to time.
10.65
Equity Distribution Agreement, dated September 20, 2019, by and between Interpace Diagnostics Group, Inc. and Oppenheimer & Co. Inc., incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed with the SEC on September 20, 2019.
10.66
Securities Purchase and Exchange Agreement, dated January 10, 2020, by and among Interpace Biosciences, Inc., 1315 Capital II, L.P. and Ampersand 2018 Limited Partnership, incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed with the SEC on January 14, 2020.
10.67
Amended and Restated Investor Rights Agreement, dated as of January 15, 2020, by and among Interpace Biosciences, Inc., 1315 Capital II, L.P. and Ampersand 2018 Limited Partnership, incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed with the SEC on January 17, 2020.
10.68
Support Agreement, dated April 7, 2020, by and between Ampersand 2018 Limited Partnership and Interpace Biosciences, Inc., incorporated by reference to Exhibit 10.1 of the Company’s quarterly report on Form 10-Q for the quarter ended June 30, 2020, filed with the SEC on October 19, 2020.
10.69
Termination Agreement, dated July 9, 2020, by and between Ampersand 2018 Limited Partnership and Interpace Biosciences, Inc., incorporated by reference to Exhibit 10.3 of the Company’s quarterly report on Form 10-Q for the quarter ended June 30, 2020, filed with the SEC on October 19, 2020.
10.70
Support Agreement, dated April 2, 2020, by and between 1315 Capital II, L.P. and Interpace Biosciences, Inc., incorporated by reference to Exhibit 10.2 of the Company’s quarterly report on Form 10-Q for the quarter ended June 30, 2020, filed with the SEC on October 19, 2020.
10.71
First Loan Modification Agreement, dated March 18, 2019, by and among Silicon Valley Bank, Interpace Diagnostics Group, Inc. (n/k/a Interpace Biosciences, Inc.), Interpace Diagnostics Corporation, and Interpace Diagnostics, LLC, incorporated by reference to Exhibit 10.6 of the Company’s quarterly report on Form 10-Q for the quarter ended June 30, 2020, filed with the SEC on October 19, 2020.
87
Exhibit
No.
Description
10.72
Joinder and Second Loan Modification Agreement, dated October 19, 2020, by and among the Company, Interpace Diagnostics Corporation, Interpace Diagnostics, LLC, Interpace Pharma Solutions, Inc. and Silicon Valley Bank, incorporated by reference to Exhibit 4.3 of the Company’s Current Report on Form 8-K, filed with the SEC on October 23, 2020.
10.73
Promissory Note entered into between the Company and Ampersand 2018 Limited Partnership, dated January 7, 2021,incorporated by reference to Exhibit 10.3 of the Company’s quarterly report on Form 10-Q for the quarter ended March 31, 2021, filed with the SEC on May 11, 2021.
10.74
Promissory Note entered into between the Company and 1315 Capital II, L.P, dated January 7, 2021, incorporated by reference to Exhibit 10.4 of the Company’s quarterly report on Form 10-Q for the quarter ended March 31, 2021, filed with the SEC on May 11, 2021.
10.75
Security Agreement entered into between the Company and Ampersand 2018 Limited Partnership, dated January 7, 2021, incorporated by reference to Exhibit 10.5 of the Company’s quarterly report on Form 10-Q for the quarter ended March 31, 2021, filed with the SEC on May 11, 2021.
10.76
Amendment to Secured Promissory Note dated May 10, 2021 with Ampersand 2018 Limited Partnership, incorporated by reference to Exhibit 10.1 of the Company’s quarterly report on Form 10-Q for the quarter ended June 30, 2021, filed with the SEC on August 11, 2021.
10.77
Amendment to Secured Promissory Note dated May 10, 2021 with1315 Capital II, L.P., incorporated by reference to Exhibit 10.2 of the Company’s quarterly report on Form 10-Q for the quarter ended June 30, 2021, filed with the SEC on August 11, 2021.
10.78
Amendment to Security Agreement dated May 10, 2021 by and between Ampersand 2018 Limited Partnership and Interpace Biosciences, Inc., incorporated by reference to Exhibit 10.3 of the Company’s quarterly report on Form 10-Q for the quarter ended June 30, 2021, filed with the SEC on August 11, 2021.
10.79
Second Amendment to Secured Promissory Note dated June 24, 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 June 29, 2021.
10.80
Second Amendment to Secured Promissory Note dated June 25, 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 June 29, 2021.
10.81
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.
10.82
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.
10.83
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.
10.84
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.
10.85
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.
10.86
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.
10.87
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.
88
Exhibit
No.
Description
10.88
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.
10.89
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.
21.1
Subsidiaries of the Registrant, incorporated by reference to Exhibit 21.1 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on April 22, 2020, as amended from time to time.
23.1
Consent of BDO USA, LLP, filed herewith.
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, filed 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, filed herewith.
*
Denotes
compensatory plan, compensation arrangement or management contract.
ITEM
16.
Form
10-K Summary
The
Company has opted to not provide a summary.
89
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report
to be signed on its behalf by the undersigned, thereunto duly authorized.
INTERPACE
BIOSCIENCES, INC.
Date:
March 31, 2022
/s/
Thomas W. Burnell
Thomas
W. Burnell
President
and Chief Executive Officer
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, this report has been signed by the following persons on behalf
of the registrant and in the capacities indicated and on the dates indicated.
Name
Title
Date
/s/
Thomas W. Burnell
President,
Chief Executive Officer and Director
March 31, 2022
Thomas
W. Burnell
(Principal
Executive Officer)
/s/
Thomas Freeburg
Chief
Financial Officer and Treasurer
March
31, 2022
Thomas
Freeburg
(Principal
Financial and Accounting Officer)
/s/
Stephen J. Sullivan
Director
March 31, 2022
Stephen
J. Sullivan
/s/
Joseph Keegan
Director
March
31, 2022
Joseph
Keegan
/s/
Vijay Aggarwal
Director
March
31, 2022
Vijay
Aggarwal
/s/
Robert Gorman
Chairman
of the Board of Directors
March
31, 2022
Robert
Gorman
/s/
Edward Chan
Director
March
31, 2022
Edward
Chan
/s/
Fortunato Ron Rocca
Director
March
31, 2022
Fortunato
Ron Rocca
90
Interpace
Biosciences, Inc.
Index
to Consolidated Financial Statements
and
Financial Statement Schedules
Page
Report
of Independent Registered Public Accounting Firm (BDO USA, LLP; Woodbridge, NJ; PCAOB ID # 243 )
F-2
Consolidated
Financial Statements
Consolidated Balance Sheets at December 31, 2021 and 2020
F-4
Consolidated Statements of Operations for the years ended December 31, 2021 and 2020
F-5
Consolidated
Statements of Stockholders’ Deficit for the years ended December 31, 2021 and 2020
F-6
Consolidated Statements of Cash Flows for the years ended December 31, 2021 and 2020
F-7
Notes to Consolidated Financial Statements
F-8
Schedule II. Valuation and Qualifying Accounts
F-32
F- 1
Report
of Independent Registered Public Accounting Firm
Shareholders
and Board of Directors
Interpace
Biosciences, Inc.
Parsippany,
New Jersey
Opinion
on the Consolidated Financial Statements
We
have audited the accompanying consolidated balance sheets of Interpace Biosciences, Inc. and Subsidiaries (the “Company”)
as of December 31, 2021 and 2020, the related consolidated statements of operations, stockholders’ deficit, and cash flows
for each of the two years in the period ended December 31, 2021, and the related notes and schedules (collectively referred to as the
“consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material
respects, the financial position of the Company at December 31, 2021 and 2020, and the results of its operations and its cash flows for
each of the two years in the period ended December 31, 2021 , in conformity with accounting principles generally accepted in the
United States of America.
Going
Concern Uncertainty
The
accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed
in Note 3 to the consolidated financial statements, the Company has suffered operating losses, has negative operating cash flows
and is dependent upon its ability to generate profitable operations in the future and/or obtain additional financing to meet its obligations
and repay its liabilities arising from normal business operations when they come due. These conditions raise substantial doubt about
its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 3.
The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis
for Opinion
These
consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion
on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public
Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company
in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission
and the PCAOB.
We
conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part
of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing
an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether
due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles
used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
We believe that our audits provide a reasonable basis for our opinion.
Critical
Audit Matter
The
critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that
was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material
to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication
of a critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are
not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or
disclosures to which it relates.
F- 2
Revenue
Recognition
As
described in Note 1 of the consolidated financial statements, the Company’s clinical services derive revenue 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. 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, the Company estimates the amount of variable consideration that should be included in the transaction price using
the expected value method based on historical experience.
We
identified revenue recognition related to the measurement of the Company’s clinical services revenue recognized for each
specified test based on an estimated transaction price or NRV as a critical audit matter. The principal considerations for our
determination included the following: (i) the judgment applied by management based on historical collection rates, (ii) the
estimation of the amount of variable consideration using the expected value method based on historical experience, and (iii) the
expected collection for each test, as the estimate is affected by assumptions in payor behavior such as changes in payor mix, payor
collections, current customer contractual requirements, and experience with ultimate collection from the third-party payors Auditing
these elements involved especially challenging auditor judgment due to the nature and extent of audit effort required to address
these matters, including the extent of specialized skill or knowledge needed.
The
primary procedures we performed to address this critical audit matter included:
●
Evaluating
the consistency and reasonableness of management’s judgments and estimates of variable consideration utilizing the
expected value method based on its historical experience in its calculation of net realizable value.
●
Comparing
the significant assumptions and inputs used by management to the Company’s fee schedule, third-party payor collection
trends, and assessing the historical accuracy of the cash collections used in the Company’s revenue models and assessing the
completeness of adjustments to estimates of future cash collections as a result of significant subsequent contract amendments,
changes in collection trends and changes in payor behavior.
We
have served as the Company’s auditor since 2012.
/s/
BDO USA, LLP
Woodbridge,
New Jersey
March
31, 2022
F- 3
INTERPACE BIOSCIENCES, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
December 31,
December 31,
2021
2020
ASSETS
Current assets:
Cash and cash equivalents
$ 3,064
$ 2,772
Restricted cash
250
600
Accounts receivable, net of allowance for doubtful accounts of $ 72 and $ 275 ,
respectively
6,158
8,028
Other current assets
2,694
2,722
Total current assets
12,166
14,122
Property and equipment, net
6,349
7,349
Other intangible assets, net
7,287
11,351
Goodwill
8,433
8,433
Operating lease right of use assets
4,032
4,384
Other long-term assets
160
42
Total assets
$ 38,427
$ 45,681
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable
$ 2,694
$ 4,511
Accrued salary and bonus
3,024
3,161
Other accrued expenses
9,198
9,795
Current liabilities from discontinued operations
766
766
Total current liabilities
15,682
18,233
Contingent consideration
1,383
1,818
Operating lease liabilities, net of current portion
3,154
3,540
Line of credit
1,500
-
Note payable at fair value
7,942
-
Other long-term liabilities
4,648
4,637
Total liabilities
34,309
28,228
Commitments and contingencies (Note 11)
-
-
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; 4,228,169 and
4,075,257 shares issued, respectively; 4,195,412 and 4,055,593 shares outstanding, respectively
403
402
Additional paid-in capital
186,106
184,404
Accumulated deficit
( 227,059 )
( 212,116 )
Treasury stock, at cost ( 32,757 and 19,664 shares, respectively)
( 1,868 )
( 1,773 )
Total stockholders’ deficit
( 42,418 )
( 29,083 )
Total liabilities and stockholders’ deficit
$ ( 8,109 )
$ ( 855 )
Total liabilities, preferred stock and stockholders’ deficit
$ 38,427
$ 45,681
The
accompanying notes are an integral part of these consolidated financial statements
F- 4
INTERPACE
BIOSCIENCES, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
(in
thousands, except for per share data)
2021
2020
For The Years Ended December 31,
2021
2020
Revenue, net
$ 41,314
$ 32,398
Cost of revenue (excluding amortization of $ 4,064 and $ 4,461 , respectively)
23,369
21,673
Gross profit
17,945
10,725
Operating expenses:
Sales and marketing
10,067
9,254
Research and development
1,882
2,795
General and administrative
13,669
18,192
Transition expense
2,585
2,578
Loss on DiamiR transaction
13
-
Acquisition related amortization expense
4,064
4,461
Change in fair value of contingent consideration
( 338 )
( 489 )
Total operating expenses
31,942
36,791
Operating loss
( 13,997 )
( 26,066 )
Interest accretion expense
( 496 )
( 549 )
Related party interest
( 424 )
-
Other (expense) income, net
( 496 )
467
Loss from continuing operations before tax
( 15,413 )
( 26,148 )
(Benefit) provision for income taxes
( 667 )
53
Loss from continuing operations
( 14,746 )
( 26,201 )
Loss from discontinued operations, net of tax
( 197 )
( 250 )
Net loss
( 14,943 )
( 26,451 )
Less adjustment for preferred stock deemed dividend
-
( 3,033 )
Net loss attributable to common stockholders
$ ( 14,943 )
$ ( 29,484 )
Basic and diluted loss per share of common stock:
From continuing operations
$ ( 3.57 )
$ ( 7.26 )
From discontinued operations
( 0.04 )
( 0.06 )
Net loss per basic and diluted share of common stock
$ ( 3.61 )
$ ( 7.32 )
Weighted average number of common shares and common share equivalents outstanding:
Basic
4,135
4,029
Diluted
4,135
4,029
The
accompanying notes are an integral part of these consolidated financial statements
F- 5
INTERPACE
BIOSCIENCES, INC.
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ DEFICIT
(in
thousands)
For The Year Ended
For The Year Ended
December 31, 2021
December 31, 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
-
-
-
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
Common stock issued
34
-
15
-
Balance at December 31
4,228
403
4,075
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 )
Treasury stock purchased
13
( 95 )
1
( 3 )
Balance at December 31
33
( 1,868 )
20
( 1,773 )
Additional paid-in capital:
Balance at January 1
184,404
182,514
Common stock issued
108
-
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 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
Common stock issued through market sales, net of expenses
-
-
Stock-based compensation expense
54
861
Balance at December 31
186,106
184,404
Accumulated deficit:
Balance at January 1
( 212,116 )
( 185,665 )
Net loss
( 4,207 )
( 6,494 )
Adoption of ASC 842
-
-
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 )
Net loss
( 3,729 )
( 8,143 )
Balance at December 31
( 227,059 )
( 212,116 )
Total stockholders’ deficit
$ ( 42,418 )
$ ( 29,083 )
The
accompanying notes are an integral part of these consolidated financial statements
F- 6
INTERPACE
BIOSCIENCES, INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(in
thousands)
2021
2020
For The Years Ended December 31,
2021
2020
Cash Flows From Operating Activities
Net loss
$ ( 14,943 )
$ ( 26,451 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
5,374
5,501
Interest accretion expense
496
549
Bad debt (recovery) expense
( 140 )
585
Reversal of 2019 bonus accrual
-
( 1,156 )
Mark to market on warrants
50
( 61 )
Amortization of deferred financing fees
122
-
Accrued interest - note payable
120
-
Note payable fees
312
-
Stock-based compensation
1,255
2,187
ESPP expense
113
55
Change in fair value of note payable
( 58 )
-
Deferred income taxes
38
37
Loss on DiamiR transaction
13
-
Change in fair value of contingent consideration
( 338 )
( 489 )
Asset impairment
-
37
Other gains and expenses, net
( 2 )
-
Other changes in operating assets and liabilities:
Decrease in accounts receivable
2,148
1,725
Decrease in other current assets
28
241
Increase in other long-term assets
( 118 )
-
Decrease in accounts payable
( 1,817 )
( 198 )
(Decrease) increase in accrued salaries and bonus
( 137 )
1,976
(Decrease) increase in accrued liabilities
( 1,086 )
1,395
(Decrease) increase in long-term liabilities
( 149 )
88
Net cash used in operating activities
( 8,719 )
( 13,979 )
Cash Flows From Investing Activity
Purchase of property and equipment
( 354 )
( 1,575 )
Sale of property and equipment
39
-
Net cash used in investing activities
( 315 )
( 1,575 )
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
-
Loan proceeds - BroadOak
8,000
-
Loan expenses - BroadOak
( 312 )
-
Payment of related party note and related interest
( 7,924 )
-
Financing fees - related party
( 123 )
-
Borrowings (payments) on Line of Credit
1,500
( 3,000 )
Cash paid for repurchase of restricted shares
-
( 52 )
Net cash provided by financing activities
8,976
16,605
Net (decrease) increase in cash, cash equivalents and restricted cash
( 58 )
1,051
Cash, cash equivalents and restricted cash – beginning
3,372
2,321
Cash, cash equivalents and restricted cash – ending
$ 3,314
$ 3,372
The
accompanying notes are an integral part of these consolidated financial statements
F- 7
1.
Nature
of Business and Significant Accounting Policies
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.
Principles
of Consolidation
The
accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”).
The consolidated financial statements include the accounts of Interpace Biosciences, Inc. fka Interpace Diagnostics Group, Inc., Interpace
Diagnostics Corporation, Interpace Diagnostics, LLC and Interpace Pharma Solutions, Inc. fka Interpace Biopharma, Inc.
Discontinued
operations include the Company’s wholly-owned subsidiaries: Group DCA, LLC (“Group DCA”), InServe Support Solutions
(Pharmakon), and TVG, Inc. (TVG, dissolved December 31, 2014) and its Commercial Services (“CSO”) business unit. All significant
intercompany balances and transactions have been eliminated in consolidation.
The
Company has one reporting segment: the Company’s clinical and pharma services business. The Company’s current reporting segment
structure is reflective of the way the Company’s management views the business, makes operating decisions and assesses performance.
This structure allows investors to better understand Company performance, better assess prospects for future cash flows, and make more
informed decisions about the Company.
Accounting
Estimates
The
preparation of 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 and notes, revenue recognition, unrecognized tax benefits, and asset impairments involving other intangible assets.
The Company periodically reviews these matters and reflects changes in estimates as appropriate. Actual results could materially differ
from those estimates.
Reverse
stock split
On
January 15, 2020, the Company effected a one-for-ten reverse split of its issued and outstanding shares of its common stock (the “Reverse
Stock Split”). Every 10 shares of common stock issued and outstanding were automatically combined into one share of issued and
outstanding common stock, without any change in the par value per share . The Company’s issued and outstanding stock decreased from
39,323,701 to 3,932,370 and 39,205,895 to 3,920,589 at December 31, 2019. All information related to common stock, stock options, restricted
stock units, warrants and earnings per share have been retroactively adjusted to give effect to the reverse stock split for all periods
presented.
F- 8
Cash
and Cash Equivalents
Cash
and cash equivalents include unrestricted cash accounts, money market investments and highly liquid investment instruments with original
maturity of three months or less at the date of purchase.
Accounts
Receivable, Net
The
Company’s accounts receivables represent unconditional rights to consideration and are generated using its proprietary tests 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.
Other
current assets
Other
current assets consisted of the following as of December 31, 2021 and 2020:
Schedule
of Current Assets
December 31, 2021
December 31, 2020
Lab supply inventory
$ 1,786
$ 2,052
Prepaid expenses
800
625
Other
108
45
Total other current assets
$ 2,694
$ 2,722
Property
and Equipment, net
Property
and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization is recognized on a straight-line
basis, using the estimated useful lives of: seven to twelve years for furniture and fixtures; two to five years for office and computer
equipment; three to twelve years for lab equipment; and leasehold improvements are amortized over the shorter of the estimated service
lives or the terms of the related leases which are currently three to ten years . Repairs and maintenance are charged to expense as incurred.
Upon disposition, the asset and related accumulated depreciation and amortization are removed from the related accounts and any gains
or losses are reflected in operations.
Software
Costs
Internal-Use
Software - It is the Company’s policy to capitalize certain costs incurred in connection with developing or obtaining internal-use
software. Capitalized software costs are included in property and equipment on the consolidated balance sheet and amortized over the
software’s useful life, generally three to seven years . Software costs that do not meet capitalization criteria are expensed immediately.
External-Use
Software - It is the Company’s policy to capitalize certain costs incurred in connection with developing or obtaining external-use
software. Capitalized software costs are included in property and equipment on the consolidated balance sheet and amortized over the
software’s useful life, generally three years . Software costs that do not meet capitalization criteria are expensed immediately.
See
Note 6, Property and Equipment , for further information.
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 Consolidated Statements of Operations.
F- 9
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.
As
a result of overall economic conditions related to the coronavirus pandemic, the impact of the coronavirus pandemic on the Company’s
financial results, and the decrease in the price of the Company’s common stock noted during the third quarter of fiscal 2020, the
Company performed an internal review of its long-lived assets. Due to an extended delay in the launch of the Company’s Barrett’s
test, the Company believes there was a triggering event in Fiscal 2016. The Company applied the required procedures under ASC 360 and
assessed the estimated future cash flows related to the Barrett’s intangible asset on an undiscounted basis. It was determined
that the carrying value of the asset was in excess of the undiscounted cash flows as of December 31, 2016. As a result, the Company performed
a formal valuation of the asset on a discounted basis in order to measure the related impairment.
Contingencies
In
the normal course of business, the Company is subject to various contingencies. Contingencies are recorded in the consolidated financial
statements when it is probable that a liability will be incurred and the amount of the loss is reasonably estimable, or otherwise disclosed,
in accordance with ASC 450, Contingencies. Significant judgment is required in both the determination of probability and the determination
as to whether a loss is reasonably estimable. In the event the Company determines that a loss is not probable, but is reasonably possible,
and it becomes possible to develop what the Company believes to be a reasonable range of possible loss, then the Company will include
disclosures related to such matter as appropriate and in compliance with ASC 450. To the extent there is a reasonable possibility that
the losses could exceed the amounts already accrued, the Company will, when applicable, adjust the accrual in the period the determination
is made, disclose an estimate of the additional loss or range of loss, indicate that the estimate is immaterial with respect to its financial
statements as a whole or, if the amount of such adjustment cannot be reasonably estimated, disclose that an estimate cannot be made.
The Company is not currently involved in any legal proceedings of a material nature and, accordingly, the Company has not accrued estimated
costs related to any legal claims.
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. Revenue is recognized based on the estimated transaction price or 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 would affect net revenue in the
period such variances become known.
F- 10
For
our pharma services, 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.
The
Company elected the practical expedient to expense contract costs as incurred related to clinical services because the contract term
is less than one year. Contract costs for pharma services were not significant.
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.
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.
Stock-Based
Compensation
The
compensation cost associated with the granting of stock-based awards is based on the grant date fair value of the stock award. The Company
recognizes the compensation cost, net of estimated forfeitures, over the shorter of the vesting period or the period from the grant date
to the date when retirement eligibility is achieved. Forfeitures are initially estimated based on historical information and subsequently
updated over the life of the awards to ultimately reflect actual forfeitures. As a result, changes in forfeiture activity can influence
the amount of stock compensation cost recognized from period to period. The Company primarily uses the Black-Scholes option-pricing model
to determine the fair value of stock options. The determination of the fair value
of stock-based payment awards is made on the date of grant and is affected by the Company’s stock price as well as assumptions
made regarding a number of complex and subjective variables. These assumptions include: expected stock price volatility over the term
of the awards; actual and projected employee stock option exercise behaviors; the risk-free interest rate; and expected dividend yield.
The fair value of restricted stock units, or RSUs, and restricted shares is equal to the closing stock price on the date of grant. In
2020, the Company issued performance-based options and RSUs based on achieving stock price or certain other financial metrics. These
require the Company to assess the likelihood of achieving certain performance milestones on a quarterly basis. In these instances, the
Company has the initial valuation model prepared by an outside expert.
See
Note 15, Stock-Based Compensation, for further information.
Treasury
Stock
Treasury
stock purchases are accounted for under the cost method whereby the entire cost of the acquired stock is recorded as treasury stock.
Upon reissuance of shares, the Company records any difference between the weighted-average cost of such shares and any proceeds received
as an adjustment to additional paid-in capital.
Leases
The
Company determines if an arrangement contains a lease in whole or in part at the inception of the contract. Right-of-use (“ROU”)
assets represent the Company’s right to use an underlying asset for the lease term while lease liabilities represent our obligation
to make lease payments arising from the lease. All leases with terms greater than twelve months result in the recognition of a ROU asset
and a liability at the lease commencement date based on the present value of the lease payments over the lease term. Unless a lease provides
all of the information required to determine the implicit interest rate, we use our incremental borrowing rate based on the information
available at the commencement date in determining the present value of the lease payments. We use the implicit interest rate in the lease
when readily determinable.
Our
lease terms include all non-cancelable periods and may include options to extend (or to not terminate) the lease when it is reasonably
certain that we will exercise that option. Leases with terms of twelve months or less at the commencement date are expensed on a straight-line
basis over the lease term and do not result in the recognition of an asset or liability. See Note 8, Leases .
F- 11
Income
taxes
Income
taxes are based on income for financial reporting purposes calculated using the Company’s expected annual effective rate and reflect
a current tax liability or asset for the estimated taxes payable or recoverable on the current year tax return and expected annual changes
in deferred taxes. Any interest or penalties on income tax are recognized as a component of income tax expense.
The
Company accounts for income taxes using the asset and liability method. This method requires recognition of deferred tax assets and liabilities
for expected future tax consequences of temporary differences that currently exist between tax bases and financial reporting bases of
the Company’s assets and liabilities based on enacted tax laws and rates. Deferred tax expense (benefit) is the result of changes
in the deferred tax asset and liability. A valuation allowance is established, when necessary, to reduce the deferred income tax assets
when it is more likely than not that all or a portion of a deferred tax asset will not be realized.
The
Company operates in multiple tax jurisdictions and pays or provides for the payment of taxes in each jurisdiction where it conducts business
and is subject to taxation. The breadth of the Company’s operations and the complexity of the tax law require assessments of uncertainties
and judgments in estimating the ultimate taxes the Company will pay. The final taxes paid are dependent upon many factors, including
negotiations with taxing authorities in various jurisdictions, outcomes of tax litigation and resolution of proposed assessments arising
from federal and state audits. Uncertain tax positions are recognized in the financial statements when it is more likely than not (i.e.,
a likelihood of more than fifty percent) that a position taken or expected to be taken in a tax return would be sustained upon examination
by tax authorities that have full knowledge of all relevant information. A recognized tax position is then measured as the largest amount
of benefit that is greater than fifty percent likely to be realized upon ultimate settlement . The Company adjusts accruals for unrecognized
tax benefits as facts and circumstances change, such as the progress of a tax audit. However, any adjustments made may be material to
the Company’s consolidated results of operations or cash flows for a reporting period. Penalties and interest, if incurred, would
be recorded as a component of current income tax expense.
Significant
judgment is also required in evaluating the need for and magnitude of appropriate valuation allowances against deferred tax assets. Deferred
tax assets are regularly reviewed for recoverability. The Company currently has significant deferred tax assets resulting from net operating
loss carryforwards and deductible temporary differences, which should reduce taxable income in future periods, if generated. The realization
of these assets is dependent on generating future taxable income.
Income
(Loss) per Share
Basic
earnings per common share are computed by dividing net income by the weighted average number of shares outstanding during the year including
any unvested share-based payment awards that contain nonforfeitable rights to dividends. Diluted earnings per common share are computed
by dividing net income by the sum of the weighted average number of shares outstanding and dilutive common shares under the treasury
method. Unvested share-based payment awards that contain nonforfeitable rights to dividends or dividend equivalents (whether paid or
unpaid), are participating securities and are included in the computation of earnings per share pursuant to the two-class method. As
a result of the losses incurred in both 2021 and 2020, the potentially dilutive common shares have been excluded from the earnings per
share computation for these periods because its inclusion would have been anti-dilutive. Additionally, preferred shares have been excluded
in the denominator of the earnings per share computation, on an if-converted basis, as such shares would have been anti-dilutive.
F- 12
2.
Recent
Accounting Standards
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.
Accounting Pronouncements
Pending Adoption
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.
3.
Going
Concern
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.
For
the fiscal year ended December 31, 2021, we had an operating loss of $ 14.0
million. As of December 31, 2021, we had cash, cash equivalents and restricted cash of $ 3.3 million,
total current assets of $ 12.2 million
and current liabilities of $ 15.7 million.
As of March 18, 2022, we had approximately $ 2.7 million
of cash on hand, excluding restricted cash.
In
January 2022, the Company announced that CMS issued a new billing policy whereby CMS will no longer reimburse for the use of the
Company’s ThyGeNEXT ® and ThyraMIR ® tests when billed together by the same provider/supplier for
the same beneficiary on the same date of service. On February 28, 2022, the Company announced that the National Correct Coding
Initiative (NCCI) program issued a response on behalf of CMS stating that the January 2022 billing policy reimbursement change for
ThyGeNEXT ® (0245U) and ThyraMIR ® (0018U) tests has been retroactively reversed to January 1, 2022. CMS
is currently reimbursing the Company for one of its two thyroid tests, and has agreed to retroactively reimburse for the second test
once they have completed their internal administrative adjustments. We have been notified by CMS/NCCI that processing of claims for
dates of service after January 1, 2022 will be completed beginning July 1, 2022. As of the date of this filing, the Company has not
yet realized the full cash collection benefit of current and retroactive Thyroid testing and such cash collections may be
temporarily reduced or delayed until we resolved the matter with CMS. As of the date of this Report, the Company currently
anticipates that current cash and cash equivalents will be insufficient to meet its anticipated cash requirements through the next
twelve months. These factors raise substantial doubt about the Company’s ability to continue as a going
concern.
On
January 7, 2021, the Company entered into secured promissory notes in the amount of $ 3 million and $ 2 million with Ampersand (“Ampersand
Note”) and 1315 Capital (“1315 Capital Note”), respectively. See Note 13, Notes Payable, 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.
F- 13
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
October 2021, the Company entered into a $ 7.5
million revolving credit facility with Comerica.
See Note 19, Revolving Line of Credit , for more details. 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 discussed above. See Note 13, Notes
Payable, for more details.
Although
the Company is targeting to achieve adjusted EBITDA and cash flow breakeven during Fiscal 2022, we may not generate positive cash flows
from operations for the year ending December 31, 2022. We intend to meet our ongoing capital needs by using our available cash and availability
under the Comerica Loan Agreement, as well as through revenue growth and margin improvement; collection of accounts receivable; containment
of costs; and the potential use of other financing options. However, if we are unable to meet the financial covenants under the Comerica
Loan Agreement, the revolving line of credit and notes payable will become due and payable immediately.
The
Company is exploring various dilutive and non-dilutive sources of funding, including equity and debt financings, strategic alliances,
business development and other sources in order to provide additional liquidity and expand the business through acquisitions or other
strategic transactions. With the Company’s delisting from Nasdaq in February 2021, its ability to raise additional capital on terms
acceptable to the Company may be adversely impacted. There can be no assurance that the Company will be successful in obtaining such
funding on terms acceptable to the Company. In January 2022, the Company’s registration statement for a rights offering become
effective. The rights offering was subsequently terminated in January 2022.
4.
Discontinued
Operations
The
Company accounts for business dispositions and its businesses held for sale in accordance with ASC 205-20, Discontinued Operations. ASC
205-20 requires the results of operations of business dispositions to be segregated from continuing operations and reflected as discontinued
operations in current and prior periods.
The
components of liabilities classified as discontinued operations relate to Commercial Services and consist of the following as of December
31, 2021 and December 31, 2020:
Schedule of Discontinued Operations
December 31,
2021
December 31,
2020
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 consolidated statements of operations for the years ended December 31, 2021 and
2020.
2021
2020
Years Ended
December 31,
2021
2020
Income from discontinued operations, before tax
$ -
$ -
Income tax expense
197
250
Loss from discontinued operations, net of tax
$ ( 197 )
$ ( 250 )
F- 14
5.
Fair
Value Measurements
Cash
and cash equivalents, accounts receivable, and accounts payable approximate fair value due to their relative short-term nature. The Company’s
financial liabilities reflected at fair value in the consolidated financial statements include contingent consideration, notes payable,
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
for assets and liabilities include certain unobservable inputs in the assumptions and projections used 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 December 31, 2021
Fair Value Measurements
Carrying
Fair
As of December 31, 2021
Amount
Value
Level 1
Level 2
Level 3
Liabilities:
Contingent consideration:
Asuragen
$ 1,871
$ 1,871
$ -
$ -
$ 1,871
Other accrued expenses:
Warrant
liability
71
71
-
-
71
Note payable:
BroadOak loan
7,942
7,942
-
-
7,942
$ 9,884
$ 9,884
$ -
$ -
$ 9,884
F- 15
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
$ 2,216
$ 2,216
$ -
$ -
$ 2,216
Other long-term liabilities:
Warrant
liability
21
21
-
-
21
$ 2,237
$ 2,237
$ -
$ -
$ 2,237
In
connection with the acquisition of certain assets from Asuragen, the Company recorded contingent consideration related to contingent
payments and other revenue-based payments. The Company determined the fair value of the contingent consideration based on a probability-weighted
income approach derived from revenue estimates. The fair value measurement is based on significant inputs not observable in the market
and thus represents a Level 3 measurement.
In connection with the
BroadOak loan, the Company records the loan at fair value. The fair value of the loan is determined by a probability-weighted
approach regarding the loan’s change in control feature. See Note 13, Notes Payable, for more details. The fair value
measurement is based on the estimated probability of a change in control and thus represents a Level 3 measurement.
Schedule of Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation
Adjustment
Accretion/
to
Fair Value/
December
31,
2020
Loan
Received
Payments
Interest
Accrued
Mark
to
Market
December
31,
2021
Asuragen
$
2,216
-
$
( 503
)
$
496
$
( 338
)
$
1,871
Underwriters
Warrants
21
-
-
-
50
71
BroadOak
Loan
-
8,000
-
-
( 58
)
7,942
$
2,237
$
8,000
$
( 5 03
)
$
496
$
( 346
)
$
9,884
Certain
of the Company’s non-financial assets, such as other intangible assets are measured at fair value on a nonrecurring basis when
there is an indicator of impairment and recorded at fair value only when an impairment charge is recognized.
6.
Property
and Equipment
Property
and equipment consisted of the following as of December 31, 2021 and 2020:
Schedule of Property and Equipment
2021
2020
December 31,
2021
2020
Furniture and fixtures
$ 339
$ 339
Lab and office equipment
7,837
7,536
Computer equipment
331
339
Internal-use software
1,572
1,572
Leasehold improvements
506
505
Property and equipment
10,585
10,291
Less accumulated depreciation and amortization
( 4,236 )
( 2,942 )
Net property and equipment
$ 6,349
$ 7,349
Depreciation
and amortization expense from continuing operations was approximately $ 1.2 million and $ 0.8 million for the years ended December 31,
2021 and 2020, respectively. There was internal-use software amortization expense included in depreciation and amortization expense in
2021 of approximately $ 0.3 million. As of December 31, 2021, capitalized external-use software was fully amortized.
F- 16
7.
Goodwill
and Other Intangible Assets
Goodwill
is attributable to the acquisition of the Biopharma business from CGI 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. The
goodwill balance at December 31, 2021 was $ 8.4 million. The net carrying value of the identifiable intangible assets as of December 31,
2021 and December 31, 2020 is as follows:
Schedule of Identifiable Intangible Assets Carrying Value
As of December 31, 2021
As of December 31, 2020
Life
Carrying
Carrying
(Years)
Amount
Amount
Asuragen acquisition:
Thyroid
9
$ 8,519
$ 8,519
RedPath acquisition:
Pancreas test
7
16,141
16,141
Barrett’s test
9
6,682
6,682
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
$ ( 31,964 )
$ ( 27,900 )
Net Carrying Value
$ 7,287
$ 11,351
The
following table displays a roll forward of the carrying amount of goodwill from January 1, 2020 to December 31, 2021:
Schedule of Goodwill Carrying Value
Carrying
Amount
Balance as of January 1, 2020
$ 8,433
Adjustments
-
Balance as of December 31, 2020
$ 8,433
Adjustments
-
Balance as of December 31, 2021
$ 8,433
Amortization
expense was approximately $ 4.1 million and $ 4.5 million for the years ended December 31, 2021 and 2020, respectively. Estimated amortization
expense for the next five years is as follows:
Schedule of Future Estimated Amortization Expense
2022
2023
2024
2025
2026
$ 2,143
$ 1,734
$ 873
$ 873
$ 873
F- 17
8.
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
December 31, 2021
Assets
Financing lease assets
Property and equipment, net
$ 636
Operating lease assets
Operating lease right of use assets
4,032
Total lease assets
$ 4,668
Liabilities
Current
Financing lease liabilities
Other accrued expenses
$ 79
Operating lease liabilities
Other accrued expenses
1,041
Total current lease liabilities
$ 1,120
Noncurrent
Financing lease liabilities
Other long-term liabilities
59
Operating lease liabilities
Operating lease liabilities, net of current portion
3,154
Total long-term lease liabilities
3,213
Total lease liabilities
$ 4,333
The
weighted average remaining lease term for the Company’s operating leases was 6.4 years as of December 31, 2021 and 7.1 years as
of December 31, 2020 and the weighted average discount rate for those leases was 6.5 % and 6.0 % as of December 31, 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 undiscounted cash flows to the lease liabilities recorded on the Company’s Consolidated Balance Sheet
as of December 31, 2021:
Schedule of Maturities of Operating and Financing Lease Liabilities
Operating Leases
Financing Leases
2022
$ 1,295
$ 86
2023
897
60
2024
567
-
2025
402
-
2026-2030
1,924
-
Total minimum lease payments
5,085
146
Less: amount of lease payments representing effects of discounting
890
8
Present value of future minimum lease payments
4,195
138
Less: current obligations under leases
1,041
79
Long-term lease obligations
$ 3,154
$ 59
F- 18
9.
Retirement
Plans
The
Company offers an employee 401(k) saving plan. Under the Interpace Biosciences, Inc. 401(k) Plan, employees may contribute up to 50 %
of their pre- or post-tax base compensation. The Company currently offers a safe harbor matching contribution equal to 100 % of the first
3 % of the participant’s contributed base salary plus 50 % of the participant’s base salary contributed exceeding 3 % but not
more than 5 % . Participants are not allowed to invest any of their 401(k) funds in the Company’s common stock. The Company’s
total contribution expense from continuing operations related to the 401(k) plan for the years ended December 31, 2021 and December 31,
2020 was approximately $ 0.3 million and $ 0.4 million, respectively.
10.
Accrued
Expenses and Other Long-Term Liabilities
Other
accrued expenses consisted of the following as of December 31, 2021 and 2020:
Schedule of Other Accrued Expenses
December 31, 2021
December 31, 2020
Accrued royalties
$ 3,890
$ 2,710
Contingent consideration
488
398
Upfront Medicare payment
-
2,066
Operating lease liability
1,041
1,027
Financing lease liability
79
177
Deferred revenue
40
54
Interest payable
120
-
Warrant liability
71
-
Accrued sales and marketing - diagnostics
47
51
Accrued lab costs - diagnostics
228
161
Accrued professional fees
932
854
Taxes payable
245
334
Unclaimed property
565
565
All others
1,452
1,398
Total other accrued expenses
$ 9,198
$ 9,795
Other
long-term liabilities consisted of the following as of December 31, 2021 and 2020:
Schedule of Long Term Liabilities
December 31, 2021
December 31, 2020
Warrant liability
$ -
$ 21
Uncertain tax positions
4,577
4,342
Deferred revenue
13
136
Other
58
138
Total other long-term liabilities
$ 4,648
$ 4,637
11.
Commitments
and Contingencies
The
Company leases facilities and certain equipment under agreements classified as operating leases, which expire at various dates through
May 2030 . Substantially all of the property leases provide for increases based upon use of utilities and landlord’s operating expenses
as well as pre-defined rent escalations. Total expense from continuing operations under these agreements for the years ended December
31, 2021 and 2020 was approximately $ 1.2 million and $ 2.1 million, respectively.
F- 19
As
of December 31, 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 are 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
$ 5,085
$ 1,295
$ 1,464
$ 816
$ 1,510
Total
$ 5,085
$ 1,295
$ 1,464
$ 816
$ 1,510
Litigation
Due
to the nature of the businesses in which the Company is engaged it is subject to certain risks. Such risks include, among others, risk
of liability for personal injury or death to persons using products the Company promotes or commercializes. There can be no assurance
that substantial claims or liabilities will not arise in the future due to the nature of the Company’s business activities and
recent increases in litigation related to healthcare products.
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.
12.
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.
F- 20
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.
As
of December 31, 2021 and 2020, there were 47,000 Series B issued and outstanding shares of preferred stock, respectively.
13.
Notes
Payable
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 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, which include restrictions on certain mergers, acquisitions, investments, encumbrances,
etc., could adversely affect our ability to conduct our business. The BroadOak Loan Agreement also contains customary events of default.
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.
F- 21
As
a condition for BroadOak to extend the Term Loan to the Company and its subsidiaries, the Company’s existing creditor, Comerica,
and BroadOak entered into that certain Subordination and Intercreditor Agreement, dated as of November 1, 2021, pursuant to which BroadOak
agreed to subordinate all of the indebtedness and obligations of the Company and its subsidiaries owing to BroadOak to all of the indebtedness
and obligations of the Company and its subsidiaries owing to Comerica (the “Intercreditor Agreement”). BroadOak further agreed
to subordinate all of its respective security interests in assets or property of the Company and its subsidiaries to Comerica’s
security interests in such assets or property. The Intercreditor Agreement provides that it is solely for the benefit of BroadOak and
Comerica and is not for the benefit of the Company or any of its subsidiaries.
The
Company concluded that the Note met the definition of a “recognized financial liability” which is an acceptable financial
instrument eligible for the fair value option under ASC 825-10-15-4, and did not meet the definition of any of the financial instruments
listed within ASC 825-10-15-5 that are not eligible for the fair value option. The Note is not convertible and does not have any component
recorded to shareholders’ equity. Accordingly, the Company elected the fair value option for the Note.
Secured
Promissory Notes – Related Parties
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 38.7 %
and 26.3 %
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 12, 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 was 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 were due on the Notes until their maturity date. All payments on
the Notes were 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, August 31, 2021, and September 29, 2021, the Company and Ampersand amended the Ampersand Note to change its maturity date
to the earlier of (a) August 31, 2021, September 30, 2021, and October 31, 2021, respectively 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, August 31, 2021, and September 29,
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 remained in full force and
effect, and was not amended in connection with the amendments to the Notes.
In
the case of the amendments, the Company reviewed the changes in accordance with ASC 470 and determined they should be treated as modifications.
F- 22
The
Notes contained certain negative covenants which prevented 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
Company used the proceeds of the BroadOak Term Loan discussed above 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.
14.
Warrants
Warrants
outstanding and warrant activity for the year ended December 31, 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
December
31,
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 0.4 years.
F- 23
15.
Stock-Based
Compensation
The
Company’s stock-incentive program is a long-term retention program that is intended to attract, retain and provide incentives for
talented employees, officers and directors, and to align stockholder and employee interests. Currently, the Company is able to grant
options, stock appreciation rights (“SARs”) and restricted shares from the Interpace Biosciences, Inc. 2019 Equity Incentive
Plan. No new grants may be made under the Company’s prior stock incentive plan, the Interpace Diagnostics Group, Inc. (now known
as Interpace Biosciences, Inc.) Amended and Restated 2004 Stock Award and Incentive Plan (the “2004 Plan”). Unless earlier
terminated by action of the Company’s board of directors, the 2004 Plan will remain in effect until such time as no stock remains
available for delivery and the Company has no further rights or obligations under the 2004 Plan with respect to outstanding awards thereunder.
Historically,
stock options have been granted with an exercise price equal to the market value of the common stock on the date of grant, expire 10
years from the date they are granted, and generally vested over a one to three-year period for employees and members of the Board. Upon
exercise, new shares will be issued by the Company. The restricted shares and restricted stock units (“RSUs”) granted to
employees generally have a three-year graded vesting period and are subject to accelerated vesting and forfeiture under certain circumstances.
Restricted shares and RSUs granted to Board members generally have a three-year graded vesting period and are subject to accelerated
vesting and forfeiture under certain circumstances .
The
Company primarily uses the Black-Scholes option-pricing model to determine the fair value of stock options. The determination
of the fair value of stock-based payment awards on the date of grant using an option-pricing model is affected by the Company’s
stock price as well as assumptions regarding a number of complex and subjective variables. These variables include the Company’s
expected stock price volatility over the term of the awards, actual and projected employee stock option exercise behaviors, risk-free
interest rate and expected dividends. Expected volatility is based on historical volatility. As there is no trading volume for the Company’s
options, implied volatility is not representative of the Company’s current volatility so the historical volatility of the Company’s
common stock is determined to be more indicative of the Company’s expected future stock performance. The expected life is determined
using the safe-harbor method. The Company expects to use this simplified method for valuing employee options until more detailed information
about exercise behavior becomes available over time. The Company bases the risk-free interest rate on U.S. Treasury zero-coupon issues
with remaining terms similar to the expected term on the options. The Company does not anticipate paying any cash dividends in the foreseeable
future and therefore uses an expected dividend yield of zero in the option valuation model. The Company is required to estimate forfeitures
at the time of grant and revise those estimates in subsequent periods if actual forfeitures differ from those estimates. The Company
uses historical data to estimate pre-vesting option forfeitures and records stock-based compensation expense only for those awards that
are expected to vest. The Company recognizes compensation cost, net of estimated forfeitures, arising from the issuance of stock options on a straight-line basis over the vesting period of the grant.
The
Company began an employee stock purchase plan in 2020 and recognized approximately $ 0.1 million and $ 0.04 million in expense related
to that plan for the years ended December 31, 2021 and 2020, respectively.
The
estimated compensation cost associated with the granting of restricted stock and restricted stock units is based on the fair value of
the Company’s common stock on the date of grant. The Company recognizes the compensation cost, net of estimated forfeitures, arising
from the issuance of restricted stock and restricted stock units on a straight-line basis over the shorter of the vesting period or the
period from the grant date to the date when retirement eligibility is achieved.
The
following table provides the weighted average assumptions used in determining the fair value of the stock options granted during the
years ended December 31, 2021 and December 31, 2020.
Schedule
of Stock Options, Valuation Assumptions
December 31, 2021
December 31, 2020
Risk-free interest rate
0.79 %
0.75 %
Expected life
6 .0
years
6.5
years
Expected volatility
134.73 %
123.71 %
Dividend yield
-
-
The
weighted-average fair value of stock options granted during the year ended December 31, 2021 was estimated to be $ 4.64 . The weighted-average
fair value of stock options granted during the year ended December 31, 2020 was estimated to be $ 5.36 . There were 13,042 options exercised
in 2021. There were no options exercised in 2020. Historically, shares issued upon the exercise of options have been new shares and have
not come from treasury shares.
F- 24
Stock-based
compensation for the years ended December 31, 2021 and 2020 is as follows:
Schedule
of Share-Based Compensation Arrangements by Share-Based Payment Award
2021
2020
RSUs and restricted stock
$ 433
$ 176
Performance-based awards
107
265
Common stock awards
-
116
Options
715
1,630
Total stock-based compensation expense
$ 1,255
$ 2,187
A
summary of stock option activity for the year ended December 31, 2021, and changes during such year, is presented below:
Schedule
of Stock Option Activity
Weighted-Average
Weighted-
Remaining
Average
Contractual
Aggregate
Grant
Period
Intrinsic
Shares
Price
(in years)
Value
Outstanding at January 1, 2021
848,819
$
8.76
8.59
$
-
Granted
347,500
6.00
9.21
-
Exercised
( 13,042
)
9.45
Forfeited or expired
( 550,766
)
9.15
-
Outstanding at December 31, 2021
632,511
6.89
8.40
-
Exercisable at December 31, 2021
206,732
9.14
7.53
-
Vested and expected to vest
537,520
7.15
8.36
-
A
summary of the status of the Company’s non-vested options for the year ended December 31, 2021, and changes during such year, is
presented below:
Schedule
of Non Vested Option Activity
Shares
Weighted-
Average
Grant Date
Fair Value
Nonvested at January 1, 2021
487,318
$ 5.81
Granted
347,500
4.64
Vested
( 127,696 )
6.54
Forfeited
( 284,646 )
5.72
Nonvested at December 31, 2021
422,476
$ 4.78
The
aggregate fair value of options vested during the years ended December 31, 2021 and 2020 was $ 0.8 million and $ 1.5 million, respectively.
The weighted-average grant date fair value of options vested during the year ended December 31, 2020 was $ 7.34 .
F- 25
A
summary of the Company’s non-vested shares of restricted stock and restricted stock units for the year ended December 31, 2021,
and changes during such year, is presented below:
Schedule of Share-Based Compensation, Restricted Stock and Restricted Stock Units Activity
Average
Weighted-
Remaining
Average
Vesting
Aggregate
Grant Date
Period
Intrinsic
Shares
Fair Value
(in years)
Value
Nonvested at January 1, 2021
239,457
$
10.00
1.75
$
1,348,781
Granted
207,438
5.46
-
-
Vested
( 65,577
)
4.65
-
-
Forfeited
( 52,379
)
5.23
-
-
Nonvested at December 31, 2021
328,939
$
3.67
1.34
$
2,467,043
The
aggregate fair value of restricted stock units vested during each of the years ended December 31, 2021 and 2020 was $ 0.3 million and
$ 0.4 million, respectively.
As
of December 31, 2021, there was approximately $ 2.0 million of total unrecognized compensation cost, net of estimated forfeitures, related
to unvested stock options and restricted stock units.
16.
Revenue
Sources
The
Company’s clinical services customers consist primarily of physicians, hospitals and clinics. Its revenue channels include Medicare,
Medicare Advantage, Medicaid, Client Billings (hospitals, etc.), and commercial payers. The following sets forth the net revenue generated
by revenue channel accounted for more than 10% of the Company’s revenue from continuing operations during the years ended December
31, 2021 and 2020, respectively. For the years ended December 31, 2021 and December 31, 2020, revenue from Medicare was approximately
54 % and 50 % of total revenue, respectively.
Schedule of Revenue by Major Customers
Years Ended December 31,
Customer
2021
2020
Medicare
$ 17,778
$ 10,186
Medicare Advantage
$ 5,859
$ 3,566
Commercial Payors
$ 5,555
$ 4,136
Client Billings
$ 3,752
$ 2,582
17.
Income
Taxes
The
benefit from income taxes on continuing operations for the years ended December 31, 2021 and 2020 is comprised of the following:
Schedule of Components of Income Tax Expense (Benefit)
2021
2020
Current:
Federal
$ -
$ -
State
( 705 )
16
Total current
( 705 )
16
Deferred:
Federal
24
23
State
14
14
Total deferred
38
37
(Benefit) provision from income taxes
$ ( 667 )
$ 53
F- 26
The
Company performs an analysis each year to determine whether the expected future income will more likely than not be sufficient to realize
the deferred tax assets. The Company’s recent operating results and projections of future income weighed heavily in the Company’s
overall assessment. As a result of this analysis, the Company continues to maintain a full valuation allowance against its federal and
state net deferred tax assets at December 31, 2021 as the Company believes that it is more likely than not that these assets will not
be realized. In the current year, the company maintains a full valuation allowance in consolidation and no separate company deferred
tax liability recorded will be recorded.
The
tax effects of significant items comprising the Company’s deferred tax assets and (liabilities) as of December 31, 2021 and 2020
are as follows:
Schedule of Deferred Tax Assets and Liabilities
2021
2020
Deferred tax assets:
Federal net operating loss carryforwards
$ 24,923
$ 17,015
State net operating loss carryforwards
3,498
2,953
Compensation
1,844
1,492
Allowances and reserves
585
436
Intangible assets
571
292
State taxes
942
900
Credit carryforward
2
229
163(j) interest
1,047
745
Leases
41
54
Deferred revenue
95
95
Valuation allowance
( 33,170 )
( 23,684 )
Gross deferred tax assets
378
527
Deferred tax liability:
Property and equipment
( 471 )
( 582 )
Deferred tax liability-net valuation allowance
$ ( 93 )
$ ( 55 )
The
Company’s deferred tax asset and deferred tax liabilities are included within Other long-term liabilities , respectively,
within the consolidated balance sheet as of December 31, 2021 and 2020. Federal tax attribute carryforwards at December 31, 2021, consist
primarily of approximately $ 118.6
million of federal net operating losses.
In addition, the Company has approximately $ 56.3
million of state net operating losses carryforwards
post 382 ownership change. The utilization of the federal carryforwards as an available offset to future taxable income is subject to
limitations under federal income tax laws. Under
current federal income tax law, federal NOLs incurred in tax years beginning after December 31, 2017 may be carried forward indefinitely,
but the deductibility of such federal NOLs is limited to 80% of Federal Taxable Income, and current state net operating losses not utilized
begin to expire this year .
The
NOL carry forwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. NOL, and
tax credit carry forwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest
of significant stockholders over a three year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue
Code of 1986, as amended, or the Code, as well as similar state tax provisions. The amount of the annual limitation, if any, will be
determined based on the value of our company immediately prior to an ownership change. Subsequent ownership changes may further affect
the limitation in future years. Additionally, U.S. tax laws limit the time during which these carry forwards may be applied against future
taxes, therefore, we may not be able to take full advantage of these carry forwards for federal income tax purposes. During 2021, the
Company completed a 382 assessment of the available NOLs under Section 382 and determined that the Company underwent an ownership change
on March 30, 2017 and July 15, 2019 and as a result, NOLs attributable to the pre-ownership change are subject to a substantial annual
limitation under Section 382 of the Internal Revenue Code due to the multiple ownership changes. The Company has adjusted their NOL carryforwards
to address the impact of the 382 ownership change. Federal Net Operating Losses of $ 71.2
million are subject to annual limitation as of
the ownership changes for ownership changes. The remaining $ 47.4 M
of NOLs incurred post July 15, 2019 are not subject to any annual limitation and can be carried forward indefinitely.
F- 27
A
reconciliation of the difference between the federal statutory tax rates and the Company’s effective tax rate from continuing operations
is as follows:
Schedule of Effective Income Tax Rate Reconciliation
2021
2020
Federal statutory
rate
21.0 %
21.0 %
State income tax rate, net
of Federal tax benefit
4.2 %
4.0 %
Meals and entertainment
( 0.1 %)
( 0.1 %)
Valuation allowance
( 25.3 )%
( 25.0 %)
Naked credit
( 0.2 %)
( 0.1 %)
NJ
NOL credit sale
4.7 %
0.0 %
Effective
tax rate
4.3 %
( 0.2 %)
The
following table summarizes the change in uncertain tax benefit reserves for the two years ended December 31, 2020:
Schedule of Unrecognized Tax Benefits Roll Forward
Unrecognized
Tax Benefits
Balance of unrecognized benefits as of January 1, 2020
$ 877
Additions for tax positions of prior years
-
Balance as of January 1, 2021
$ 877
Additions for tax positions of prior years
-
Balance as of December 31, 2021
$ 877
As
of December 31, 2021 and 2020, the total amount of gross unrecognized tax benefits was $ 0.9 million and $ 0.9 million, respectively. The
total amount of unrecognized tax benefits that, if recognized, would affect the effective tax rate as of December 31, 2021 and 2020 was
$ 0.9 million and $ 0.9 million, respectively.
The
Company recognized interest and penalties of $ 0.2 million and $ 0.3 million, respectively, related to uncertain tax positions in income
tax expense during each of the years ended December 31, 2021 and 2020. At December 31, 2021 and 2020, accrued interest and penalties,
net were $ 3.6 million and $ 3.4 million, respectively, and included in the Other long-term liabilities in the consolidated balance
sheets.
The
Company and its subsidiaries file a U.S. Federal consolidated income tax return and consolidated and separate income tax returns in numerous
states and local tax jurisdictions. The following tax years remain subject to examination as of December 31, 2021:
Schedule of Tax Years Subject to Examination
Jurisdiction
Tax Years
Federal
2017
– 2021
State and Local
2016
– 2021
To
the extent there was a failure to file a tax return in a previous year; the statute of limitation will not begin until the return is
filed. There were no examinations in process by the Internal Revenue Service as of December 31, 2021.
F- 28
18.
Basic and Diluted Net Loss per Share
A
reconciliation of the number of shares used in the calculation of basic and diluted earnings per share for the years ended December 31,
2021 and 2020 are as follows (rounded to thousands):
Schedule of Weighted Average Number of Shares
Years Ended December 31,
2021
2020
Basic weighted average number of common shares
4,135
4,029
Potential dilutive effect of stock-based awards
-
-
Diluted weighted average number of common shares
4,135
4,029
The
Company’s Series B Preferred Stock, on an as converted basis of 7,833,334 shares 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
Years Ended December 31,
2021
2020
Options
632
849
Restricted stock units (RSUs)
329
238
Warrants
1,405
1,405
2,366
2,492
19.
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.
F- 29
The
Credit Facility matures on September 30, 2023 , and is secured by a first priority lien on substantially all of the assets of the Company
and its subsidiaries. As of December 31, 2021, the balance of the revolving line was $ 1.5 million.
The
Comerica Loan Agreement contains affirmative and negative restrictive covenants that are applicable whether or not any amounts are
outstanding under the Comerica Loan Agreement. These restrictive covenants, which include restrictions on certain mergers,
acquisitions, investments, encumbrances, etc., could adversely affect our ability to conduct our business. The Comerica Loan
Agreement also contains financial covenants requiring specified minimum liquidity and minimum revenue thresholds and 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.
Revolving
Line of Credit – Silicon Valley Bank
On
November 13, 2018 the Company, Interpace Diagnostics Corporation, and Interpace Diagnostics, LLC entered into a Loan and Security Agreement
(the “SVB Loan Agreement”) with Silicon Valley Bank (“SVB”), which provided for up to $ 4.0 million of debt financing
consisting of a term loan of up to $ 850,000 and a revolving line of credit based on its outstanding accounts receivable (the “Revolving
Line”) of up to $ 3.75 million. As of December 31, 2020, the balance of the Revolving Line with SVB was zero .
On
January 5, 2021, the Company terminated the SVB Loan Agreement in accordance with the terms of the agreement. In connection with the
termination, SVB waived its right to any termination fees and released its security interest in the assets of the Company.
20.
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 legal expenses. The following is a roll forward of the transition expenses
liabilities:
Schedule of Transition Expenses
Facilities/
Personnel
Infrastructure
Legal
Total
Balance at December 31, 2020
$ 885
$ 269
$ -
$ 1,154
Transition expenses
1,044
1,036
505
2,585
Payments
( 1,929 )
( 1,305 )
( 505 )
( 3,739 )
Balance at December 31, 2021
$ -
$ -
$ -
$ -
F- 30
21.
Supplemental
Cash Flow Information
Supplemental
Disclosure of Other Cash Flow Information
(in
thousands)
Supplemental Cash Flow Information
Cash paid for taxes
$ 369
$ 218
Cash paid for interest
$ 424
$ 60
Supplemental
Disclosures of Non Cash Activities
(in
thousands)
Years Ended
December 31,
2021
2020
Operating
Taxes accrued for repurchase of restricted shares
$ 95
$ -
Investing
Preferred Stock Deemed Dividend
$ -
$ 3,033
Investment in DiamiR
248
-
Financing
Accrued financing costs
$ -
$ 31
22.
Subsequent
Events
Centers for Medicare & Medicaid
Services (CMS) Billing Policy Notice & Rights Offering
On January 28, 2022, the Company announced
that the Centers for Medicare & Medicaid Services (CMS) issued a new billing policy whereby CMS would no longer reimburse for the
use of the Company’s ThyGeNEXT ® and ThyraMIR ® tests when billed together by the same provider/supplier
for the same beneficiary on the same date of service and that the Company was terminating its previously announced rights offering and
the mutual termination of the standby purchase agreement with 3K Limited Partnership. The CMS billing policy decision was subsequently
reversed in February 2022, however the Company has not yet realized the full cash collection benefit of current and retroactive Thyroid
testing and such cash collections may be temporarily reduced or delayed until we resolved the matter with CMS.
F- 31
INTERPACE
BIOSCIENCES, INC.
VALUATION
AND QUALIFYING ACCOUNTS
YEARS
ENDED DECEMBER 31, 2021 AND 2020
($
in thousands)
Schedule II - Valuation and Qualifying Accounts
Additions
Balance at
(Reductions)
(1)
Balance at
Beginning
Charged to
Deductions
end
Description
of Period
Operations
Other
of Period
2020
Allowance for doubtful accounts
$ 25
-
250
$ 275
Allowance for doubtful notes
$ 869
-
-
$ 869
Tax valuation allowance
$ 17,027
-
6,657
$ 23,684
2021
Allowance for doubtful accounts
$ 275
-
( 203 )
$ 72
Allowance for doubtful notes
$ 869
-
-
$ 869
Tax valuation allowance
$ 23,684
-
9,486
$ 33,170
(1)
Includes
payments and actual write offs, as well as changes in estimates in the reserves.
F- 32
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.