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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒ |
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended June 30, 2024
OR
☐ |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the transition period from _______________ to _______________
Commission
File Number: 000-24249
Interpace
Biosciences, Inc. |
(Exact
name of registrant as specified in its charter) |
Delaware |
|
22-2919486 |
(State or other jurisdiction
of |
|
(I.R.S. Employer |
Incorporation or organization) |
|
Identification No.) |
Waterview
Plaza, Suite 310, 2001 Route 46, Parsippany, NJ 07054 |
(Address of principal executive
offices and zip code) |
|
(855)
776-6419 |
(Registrant’s telephone
number, including area code) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
None |
|
N/A |
|
N/A |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”,
“smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated
filer ☐ |
|
Accelerated
filer ☐ |
Non-accelerated filer ☒ |
|
Smaller reporting company
☒ |
|
|
Emerging Growth Company
☐ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
Indicate
the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date:
Class |
|
Shares
Outstanding August 2, 2024 |
Common Stock, par value
$0.01 per share |
|
4,394,312 |
INTERPACE
BIOSICENCES, INC.
FORM
10-Q FOR PERIOD ENDED JUNE 30, 2024
TABLE
OF CONTENTS
PART
I. FINANCIAL INFORMATION
INTERPACE
BIOSCIENCES, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands, except share and per share data)
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
| |
(unaudited) | | |
| |
ASSETS | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 2,019 | | |
$ | 3,498 | |
Accounts receivable, net of allowance for credit loss of $26 and $0, respectively | |
| 6,206 | | |
| 4,983 | |
Other current assets | |
| 1,941 | | |
| 1,841 | |
Total current assets | |
| 10,166 | | |
| 10,322 | |
Property and equipment, net | |
| 1,126 | | |
| 790 | |
Operating lease right of use assets | |
| 1,635 | | |
| 1,864 | |
Other long-term assets | |
| 45 | | |
| 45 | |
Total assets | |
$ | 12,972 | | |
$ | 13,021 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ DEFICIT | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 1,761 | | |
$ | 1,544 | |
Accrued salary and bonus | |
| 1,243 | | |
| 1,969 | |
Other accrued expenses | |
| 8,582 | | |
| 8,201 | |
Note payable at fair value, current | |
| 6,784 | | |
| 5,100 | |
Current liabilities of discontinued operations | |
| 660 | | |
| 660 | |
Total current liabilities | |
| 19,030 | | |
| 17,474 | |
Operating lease liabilities, net of current portion | |
| 1,286 | | |
| 1,472 | |
Note payable at fair value | |
| - | | |
| 4,243 | |
Other long-term liabilities | |
| 5,146 | | |
| 4,968 | |
Total liabilities | |
| 25,462 | | |
| 28,157 | |
| |
| | | |
| | |
Commitments and contingencies (Note 8) | |
| - | | |
| - | |
| |
| | | |
| | |
Redeemable preferred stock, $.01 par value; 5,000,000 shares authorized, 47,000 shares Series B issued
and outstanding | |
| 46,536 | | |
| 46,536 | |
| |
| | | |
| | |
Stockholders’ deficit: | |
| | | |
| | |
Common stock, $.01 par value; 100,000,000 shares authorized; 4,487,157 and 4,447,489 shares issued,
respectively; 4,376,398 and 4,351,445 shares outstanding, respectively | |
| 406 | | |
| 405 | |
Additional paid-in capital | |
| 188,277 | | |
| 188,146 | |
Accumulated deficit | |
| (245,685 | ) | |
| (248,215 | ) |
Treasury stock, at cost (110,759 and 96,044 shares, respectively) | |
| (2,024 | ) | |
| (2,008 | ) |
Total stockholders’ deficit | |
| (59,026 | ) | |
| (61,672 | ) |
Total liabilities and stockholders’ deficit | |
| (33,564 | ) | |
| (33,515 | ) |
| |
| | | |
| | |
Total liabilities, preferred stock and stockholders’ deficit | |
$ | 12,972 | | |
$ | 13,021 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements
INTERPACE
BIOSCIENCES, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited,
in thousands, except for per share data)
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For The Three Months | | |
For The Six Months | |
| |
Ended June 30, | | |
Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Revenue, net | |
$ | 12,042 | | |
$ | 11,026 | | |
$ | 22,314 | | |
$ | 20,853 | |
Cost of revenue | |
| 4,611 | | |
| 4,191 | | |
| 8,812 | | |
| 8,039 | |
Gross profit | |
| 7,431 | | |
| 6,835 | | |
| 13,502 | | |
| 12,814 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Sales and marketing | |
| 2,887 | | |
| 2,605 | | |
| 5,707 | | |
| 4,947 | |
Research and development | |
| 146 | | |
| 186 | | |
| 283 | | |
| 335 | |
General and administrative | |
| 2,141 | | |
| 2,894 | | |
| 4,381 | | |
| 5,389 | |
Acquisition related amortization expense | |
| - | | |
| 318 | | |
| - | | |
| 635 | |
Total operating expenses | |
| 5,174 | | |
| 6,003 | | |
| 10,371 | | |
| 11,306 | |
| |
| | | |
| | | |
| | | |
| | |
Operating income from continuing operations | |
| 2,257 | | |
| 832 | | |
| 3,131 | | |
| 1,508 | |
Interest accretion expense | |
| (12 | ) | |
| (31 | ) | |
| (30 | ) | |
| (66 | ) |
Note payable interest | |
| (176 | ) | |
| (228 | ) | |
| (373 | ) | |
| (453 | ) |
Other income (expense), net | |
| 71 | | |
| (174 | ) | |
| (12 | ) | |
| (156 | ) |
Provision for income taxes | |
| 4 | | |
| 4 | | |
| 8 | | |
| 8 | |
Income from continuing operations | |
| 2,136 | | |
| 395 | | |
| 2,708 | | |
| 825 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from discontinued operations, net of tax | |
| (74 | ) | |
| (220 | ) | |
| (178 | ) | |
| (299 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net income | |
$ | 2,062 | | |
$ | 175 | | |
$ | 2,530 | | |
$ | 526 | |
| |
| | | |
| | | |
| | | |
| | |
Basic income (loss) per share of common stock: | |
| | | |
| | | |
| | | |
| | |
From continuing operations | |
$ | 0.49 | | |
$ | 0.09 | | |
$ | 0.62 | | |
$ | 0.19 | |
From discontinued operations | |
| (0.02 | ) | |
| (0.05 | ) | |
| (0.04 | ) | |
| (0.07 | ) |
Net income per basic share of common stock | |
$ | 0.47 | | |
$ | 0.04 | | |
$ | 0.58 | | |
$ | 0.12 | |
| |
| | | |
| | | |
| | | |
| | |
Diluted income (loss) per share of common stock: | |
| | | |
| | | |
| | | |
| | |
From continuing operations | |
$ | 0.49 | | |
$ | 0.09 | | |
$ | 0.62 | | |
$ | 0.19 | |
From discontinued operations | |
| (0.02 | ) | |
| (0.05 | ) | |
| (0.04 | ) | |
| (0.07 | ) |
Net income per diluted share of common stock | |
$ | 0.47 | | |
$ | 0.04 | | |
$ | 0.58 | | |
$ | 0.12 | |
| |
| | | |
| | | |
| | | |
| | |
Weighted average number of common shares and common share equivalents outstanding: | |
| | | |
| | | |
| | | |
| | |
Basic | |
| 4,376 | | |
| 4,311 | | |
| 4,373 | | |
| 4,309 | |
Diluted | |
| 4,401 | | |
| 4,316 | | |
| 4,393 | | |
| 4,313 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements
INTERPACE
BIOSCIENCES, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT
(unaudited,
in thousands)
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Total | |
| |
| | |
| | |
| | |
| | |
Additional | | |
| | |
| |
| |
Common Stock | | |
Treasury Stock | | |
Paid in | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Total | |
Balance -December 31, 2022 | |
| 4,367,830 | | |
$ | 405 | | |
| 71,120 | | |
$ | (1,976 | ) | |
$ | 187,516 | | |
$ | (249,017 | ) | |
$ | (63,072 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of common stock | |
| 22,996 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
Treasury stock purchased | |
| | | |
| - | | |
| 8,292 | | |
| (9 | ) | |
| - | | |
| - | | |
| (9 | ) |
Stock-based compensation expense | |
| - | | |
| - | | |
| - | | |
| - | | |
| 192 | | |
| - | | |
| 192 | |
Net income | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 351 | | |
| 351 | |
Balance -March 31, 2023 | |
| 4,390,826 | | |
$ | 405 | | |
| 79,412 | | |
$ | (1,985 | ) | |
$ | 187,708 | | |
$ | (248,666 | ) | |
$ | (62,538 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation expense | |
| - | | |
| - | | |
| - | | |
| - | | |
| 157 | | |
| - | | |
| 157 | |
Net income | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 175 | | |
| 175 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance -June 30, 2023 | |
| 4,390,826 | | |
$ | 405 | | |
| 79,412 | | |
$ | (1,985 | ) | |
$ | 187,865 | | |
$ | (248,491 | ) | |
$ | (62,206 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance -December 31, 2023 | |
| 4,447,489 | | |
$ | 405 | | |
| 96,044 | | |
$ | (2,008 | ) | |
$ | 188,146 | | |
$ | (248,215 | ) | |
$ | (61,672 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of common stock | |
| 39,668 | | |
| 1 | | |
| - | | |
| - | | |
| (1 | ) | |
| - | | |
| - | |
Treasury stock purchased | |
| - | | |
| - | | |
| 14,715 | | |
| (16 | ) | |
| - | | |
| - | | |
| (16 | ) |
Stock-based compensation expense | |
| - | | |
| - | | |
| - | | |
| - | | |
| 79 | | |
| - | | |
| 79 | |
Net income | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 468 | | |
| 468 | |
Balance -March 31, 2024 | |
| 4,487,157 | | |
$ | 406 | | |
| 110,759 | | |
$ | (2,024 | ) | |
$ | 188,224 | | |
$ | (247,747 | ) | |
$ | (61,141 | ) |
Balance | |
| 4,487,157 | | |
$ | 406 | | |
| 110,759 | | |
$ | (2,024 | ) | |
$ | 188,224 | | |
$ | (247,747 | ) | |
$ | (61,141 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation expense | |
| - | | |
| - | | |
| - | | |
| - | | |
| 53 | | |
| - | | |
| 53 | |
Net income | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 2,062 | | |
| 2,062 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance -June 30, 2024 | |
| 4,487,157 | | |
$ | 406 | | |
| 110,759 | | |
$ | (2,024 | ) | |
$ | 188,277 | | |
$ | (245,685 | ) | |
$ | (59,026 | ) |
Balance | |
| 4,487,157 | | |
$ | 406 | | |
| 110,759 | | |
$ | (2,024 | ) | |
$ | 188,277 | | |
$ | (245,685 | ) | |
$ | (59,026 | ) |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
INTERPACE
BIOSCIENCES, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited,
in thousands)
| |
2024 | | |
2023 | |
| |
For The Six Months Ended June 30, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Cash Flows From Operating Activities | |
| | | |
| | |
Net income | |
$ | 2,530 | | |
$ | 526 | |
Adjustments to reconcile net income to net cash provided by operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 119 | | |
| 714 | |
Interest accretion expense | |
| 30 | | |
| 66 | |
Amortization of deferred financing fees | |
| - | | |
| 28 | |
Stock-based compensation | |
| 132 | | |
| 349 | |
Bad debt expense reversal | |
| (100 | ) | |
| - | |
Credit loss expense | |
| 26 | | |
| - | |
Change in fair value of note payable | |
| 41 | | |
| 142 | |
Amortization on operating lease right of use asset | |
| 229 | | |
| 349 | |
Other changes in operating assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| (1,249 | ) | |
| (497 | ) |
Other current assets | |
| - | | |
| (101 | ) |
Accounts payable | |
| (13 | ) | |
| 610 | |
Accrued salaries and bonus | |
| (726 | ) | |
| (329 | ) |
Other accrued expenses | |
| 337 | | |
| (138 | ) |
Operating lease liabilities | |
| (188 | ) | |
| (337 | ) |
Other long-term liabilities | |
| 178 | | |
| 162 | |
Net cash provided by operating activities | |
| 1,346 | | |
| 1,544 | |
| |
| | | |
| | |
Cash Flows From Investing Activity | |
| | | |
| | |
Working capital adjustment on sale of Interpace Pharma Solutions | |
| - | | |
| (117 | ) |
Purchase of property and equipment | |
| (225 | ) | |
| (176 | ) |
Net cash used in investing activities | |
| (225 | ) | |
| (293 | ) |
| |
| | | |
| | |
Cash Flows From Financing Activities | |
| | | |
| | |
Payments made on note payable | |
| (2,600 | ) | |
| - | |
Payments on line of credit | |
| - | | |
| (1,000 | ) |
Net cash used in financing activities | |
| (2,600 | ) | |
| (1,000 | ) |
| |
| | | |
| | |
Net (decrease) increase in cash, cash equivalents and restricted cash | |
| (1,479 | ) | |
| 251 | |
Cash, cash equivalents and restricted cash from continuing operations– beginning | |
| 3,498 | | |
| 4,828 | |
Cash, cash equivalents and restricted cash from discontinued operations– beginning | |
| - | | |
| - | |
Cash, cash equivalents and restricted cash – beginning | |
$ | 3,498 | | |
$ | 4,828 | |
Cash, cash equivalents and restricted cash from continuing operations– ending | |
$ | 2,019 | | |
$ | 5,079 | |
Cash, cash equivalents and restricted cash from discontinued operations– ending | |
| - | | |
| - | |
Cash, cash equivalents and restricted cash – ending | |
$ | 2,019 | | |
$ | 5,079 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
INTERPACE
BIOSCIENCES, INC.
NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(Tabular
information in thousands, except per share amounts)
1. OVERVIEW
Nature
of Business
Interpace
Biosciences, Inc. (“Interpace” or the “Company”) is a company that provides molecular diagnostics, bioinformatics
and pathology services for evaluation of risk of cancer by leveraging the latest technology in personalized medicine for improved patient
diagnosis and management. The Company develops and commercializes genomic tests and related first line assays principally focused on
early detection of patients with indeterminate biopsies and at high risk of cancer using the latest technology.
2. BASIS OF PRESENTATION
The
accompanying unaudited interim condensed consolidated financial statements and related notes (the “Interim Financial Statements”)
should be read in conjunction with the consolidated financial statements of the Company and its wholly-owned subsidiaries (Interpace
Diagnostics Lab Inc., Interpace Diagnostics Corporation, and Interpace Diagnostics, LLC), and related notes as included in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities & Exchange Commission (“SEC”)
on April 1, 2024 and as amended on April 26, 2024.
The
Interim Financial Statements of the Company have been prepared in accordance with generally accepted accounting principles in the United
States (“GAAP”) for interim financial reporting and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly,
they do not include all of the information and footnotes required by GAAP for complete financial statements. The Interim Financial Statements
include all normal recurring adjustments that, in the judgment of management, are necessary for a fair presentation of such interim financial
statements. Discontinued operations include the Company’s wholly owned subsidiaries: Group DCA, LLC, InServe Support Solutions;
and TVG, Inc., its Commercial Services business unit, which was sold on December 22, 2015 and its Interpace Pharma Solutions business
(“Pharma Solutions”) which was sold on August 31, 2022. All significant intercompany balances and transactions have been
eliminated in consolidation. Operating results for the three-month period ended June 30, 2024 are not necessarily indicative of the results
that may be expected for the fiscal year ending December 31, 2024.
3. LIQUIDITY
In
October 2021, the Company entered into a $7.5 million revolving credit facility with Comerica Bank (“Comerica”) (the “Comerica
Loan Agreement”). In February 2024, the Company terminated the Comerica Loan Agreement. The Company did not owe anything outstanding
on the line of credit at the time of termination and does not owe anything further to Comerica. See Note 16, Revolving Line of Credit.
Also in October 2021, the Company entered into an $8.0 million term loan with BroadOak Fund V, L.P. (“BroadOak”) (the “Term
Loan”), the proceeds of which were used to repay in full at their maturity the existing secured promissory note with Ampersand
Capital Partners (“Ampersand”) (the “Ampersand Note”) and 1315 Capital II, L.P (“1315 Capital”) (the
“1315 Capital Note”). In May 2022, the Company entered into a Subordinated Convertible Promissory Note agreement with BroadOak
for an additional $2.0 million (the “Convertible Note”), which was converted into a subordinated term loan and was added
to the outstanding Term Loan balance. The Term Loan has been subsequently amended. See Note 13, Notes Payable, for more details.
Along
with many laboratories, the Company may be affected by the Proposed Local Coverage Determination (“LCD”) DL39365, which
is currently under consideration by Novitas, the Company’s medical administrator contractor. If finalized, this Proposed LCD,
which governs “Genetic Testing for Oncology,” could impact the existing Medicare coverage for one of our molecular
tests, PancraGEN®. On June 5, 2023, the Company announced that Novitas issued the final LCD of Genetic Testing for
Oncology (L39365) which if finalized, would have established non-coverage for the Company’s widely used
PancraGEN® test effective July 17, 2023. On July 6, 2023, Novitas announced that it would not be implementing the
final Genetic Testing for Oncology LCD (L39365) as scheduled on July 17, 2023. Novitas then issued a new virtually identical
proposed LCD affecting the same companies and tests and reaching the same conclusions as noted in the previously rescinded LCD on
July 27, 2023. In response, the Company participated in a public meeting presentation and submitted detailed written comments
supporting the use of PancraGEN®. The timing and content of any final implemented LCD is uncertain at this time; the
process could potentially take a year or longer from issuance of the updated proposed LCD to reach a conclusion. On July
29, 2024 the Company announced that CMS granted Novitas an undefined extension to the final decision for the LCD. As a
result, the Company is able to continue offering PancraGEN® and the related Point2® fluid chemistry
tests for amylase, CEA, and glucose. In the event Novitas ultimately restricts coverage for the PancraGEN® test, the
Company’s liquidity could be negatively impacted.
For
the six months ended June 30, 2024, the Company had operating income from continuing operations of $3.1 million. As of June 30, 2024,
the Company had cash and cash equivalents of $2.0 million, total current assets of $10.2 million and current liabilities of $19.0 million.
As of August 2, 2024, the Company had approximately $1.8 million of cash and cash equivalents.
The
Company intends to meet its ongoing capital needs by using its available cash, as well as through targeted margin improvement; collection
of accounts receivable; containment of costs; and the potential use of other financing options and other strategic alternatives.
The
Company continues to explore various strategic alternatives, dilutive and non-dilutive sources of funding, including equity and debt
financings, strategic alliances, business development and other sources in order to provide additional liquidity. With the delisting
of its common stock from Nasdaq in February 2021, the Company’s ability to raise additional capital on terms acceptable to it has
been adversely impacted. There can be no assurance that the Company will be successful in obtaining such funding on terms acceptable
to it.
With
the improvement in operating cash flows associated with the disposition of the Pharma Solutions business, and the Company’s improved
operating performance, as of the date of this filing, the Company anticipates that current cash and cash equivalents and forecasted cash
receipts will be sufficient to meet its anticipated cash requirements through the next twelve months from the date of the filing of this
report.
4. DISCONTINUED OPERATIONS
Liabilities
classified as discontinued operations as of both June 30, 2024 and December 31, 2023 consists of accrued expenses which are liabilities
related to the former Commercial Services business unit.
The
table below presents the significant components of its former Pharma Solutions business unit’s results included within loss from
discontinued operations, net of tax in the condensed consolidated statements of operations for the three- and six months ended June 30,
2024 and 2023.
SCHEDULE
OF COMPONENTS OF ASSETS AND LIABILITIES AND REVENUE CLASSIFIED AS DISCONTINUED
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For The Three Months Ended | | |
For The Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Revenue, net | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Loss from discontinued operations | |
| - | | |
| (137 | ) | |
| - | | |
| (137 | ) |
Income tax expense | |
| 74 | | |
| 83 | | |
| 178 | | |
| 162 | |
Loss from discontinued operations, net of tax | |
$ | (74 | ) | |
$ | (220 | ) | |
$ | (178 | ) | |
$ | (299 | ) |
Cash
used from discontinued operations, operating activities, was $20,000, and investing activities was $0.1 million for the six months ended
June 30, 2023. There was no cash used from discontinued operations for the six months ended June 30, 2024.There was no depreciation and
amortization expense for the three or six months ended June 30, 2024 and June 30, 2023, respectively, in discontinued operations.
5. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Accounting
Estimates
The
preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions
that affect the amounts of assets and liabilities reported and disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the reporting period. Management’s estimates are based on historical
experience, facts and circumstances available at the time, and various other assumptions that are believed to be reasonable under the
circumstances. Significant estimates include accounting for valuation allowances related to deferred income taxes, contingent consideration,
allowances for credit losses, revenue recognition, unrecognized tax benefits, and asset impairments involving intangible assets. The
Company periodically reviews these matters and reflects changes in estimates in earnings as appropriate. Actual results could materially
differ from those estimates.
Revenue
Recognition
We
derive our revenues from the performance of proprietary assays or tests. The Company’s performance obligation is fulfilled upon
the completion, review and release of test results to the customer. We subsequently bill third-party payers or direct-bill payers for
the tests performed. Under Accounting Standards Codification 606, revenue is recognized based on the estimated transaction price or net
realizable value, which is determined based on historical collection rates by each payer category for each proprietary test offered by
the Company. To the extent the transaction price includes variable consideration, for all third party and direct-bill payers and proprietary
tests, we estimate the amount of variable consideration that should be included in the transaction price using the expected value method
based on historical experience.
We
regularly review the ultimate amounts received from the third-party and direct-bill payers and related estimated reimbursement rates
and adjust the NRV’s and related contractual allowances accordingly. If actual collections and related NRV’s vary significantly
from our estimates, we will adjust the estimates of contractual allowances, which affects net revenue in the period such variances become
known.
Financing
and Payment
For
non-Medicare claims, our payment terms vary by payer category. Payment terms for direct-payers in our clinical services are typically
thirty days and in our pharma services, were up to sixty days. Commercial third-party-payers are required to respond to a claim within
a time period established by their respective state regulations, generally between thirty to sixty days. However, payment for commercial
third-party claims may be subject to a denial and appeal process, which could take up to two years in some instances where multiple appeals
are submitted. The Company generally appeals all denials from commercial third-party payers. We bill Medicare directly for tests performed
for Medicare patients and must accept Medicare’s fee schedule for the covered tests as payment in full.
Costs
to Obtain or Fulfill a Customer Contract
Sales
commissions are expensed in the period in which they have been earned. These costs are recorded in sales and marketing expense in the
condensed consolidated statements of operations.
Accounts
Receivable
The
Company’s accounts receivable represent unconditional rights to consideration and are generated using its clinical services. 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.
The allowance for credit losses balance was $26,000 and $0 at June 30, 2024 and December 31, 2023, respectively.
Leases
The
Company determines if an arrangement contains a lease in whole or in part at the inception of the contract. Right-of-use (“ROU”)
assets represent the Company’s right to use an underlying asset for the lease term while lease liabilities represent our obligation
to make lease payments arising from the lease. All leases with terms greater than twelve months result in the recognition of a ROU asset
and a liability at the lease commencement date based on the present value of the lease payments over the lease term. Unless a lease provides
all of the information required to determine the implicit interest rate, we use our incremental borrowing rate based on the information
available at the commencement date in determining the present value of the lease payments. We use the implicit interest rate in the lease
when readily determinable.
Our
lease terms include all non-cancelable periods and may include options to extend (or to not terminate) the lease when it is reasonably
certain that we will exercise that option. Leases with terms of twelve months or less at the commencement date are expensed on a straight-line
basis over the lease term and do not result in the recognition of an asset or liability. See Note 7, Leases.
Other
Current Assets
Other
current assets consisted of the following as of June 30, 2024 and December 31, 2023:
SCHEDULE
OF OTHER CURRENT ASSETS
| |
June 30, 2024 | | |
December 31, 2023 | |
Lab supplies | |
$ | 1,231 | | |
$ | 1,227 | |
Prepaid expenses | |
| 667 | | |
| 590 | |
Other | |
| 43 | | |
| 24 | |
Total other current assets | |
$ | 1,941 | | |
$ | 1,841 | |
Long-Lived
Assets, including Finite-Lived Intangible Assets
Finite-lived
intangible assets are stated at cost less accumulated amortization. Amortization of finite-lived acquired intangible assets is recognized
on a straight-line basis, using the estimated useful lives of the assets of approximately two years to ten years in acquisition-related
amortization expense in the condensed consolidated statements of operations.
The
Company reviews the recoverability of long-lived assets and finite-lived intangible assets whenever events or changes in circumstances
indicate that the carrying value of such assets may not be recoverable. If the sum of the expected future undiscounted cash flows is
less than the carrying amount of the asset, an impairment loss is recognized by reducing the recorded value of the asset to its fair
value measured by future discounted cash flows. This analysis requires estimates of the amount and timing of projected cash flows and,
where applicable, judgments associated with, among other factors, the appropriate discount rate. Such estimates are critical in determining
whether any impairment charge should be recorded and the amount of such charge if an impairment loss is deemed to be necessary.
Basic
and Diluted Net Income (Loss) per Share
A
reconciliation of the number of shares of common stock, par value $0.01 per share, used in the calculation of basic and diluted income
(loss) per share for the three- and six-month periods ended June 30, 2024 and 2023 is as follows:
SCHEDULE
OF BASIC AND DILUTED NET LOSS PER SHARE
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Basic weighted average number of common shares | |
| 4,376 | | |
| 4,311 | | |
| 4,373 | | |
| 4,309 | |
Potential dilutive effect of stock-based awards | |
| 25 | | |
| 5 | | |
| 20 | | |
| 4 | |
Diluted weighted average number of common shares | |
| 4,401 | | |
| 4,316 | | |
| 4,393 | | |
| 4,313 | |
The
Company’s Series B Redeemable Preferred Stock, on an as converted basis into common stock of 7,833,334 shares for the three- and
six-months ended June 30, 2024, and the following outstanding stock-based awards, were excluded from the computation of the effect of
dilutive securities on income (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
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Options | |
| 288 | | |
| 475 | | |
| 288 | | |
| 475 | |
Restricted stock units (RSUs) | |
| 182 | | |
| 215 | | |
| 187 | | |
| 217 | |
Anti-dilutive
securities | |
| 470 | | |
| 690 | | |
| 475 | | |
| 692 | |
6. FAIR VALUE MEASUREMENTS
Cash
and cash equivalents, accounts receivable and accounts payable approximate fair value due to their relative short-term nature. The Company’s
financial liabilities reflected at fair value in the condensed consolidated financial statements include contingent consideration, warrant
liability and note payable. Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly
transaction between market participants at the measurement date. In determining fair value, the Company uses various methods including
market, income and cost approaches. Based on these approaches, the Company often utilizes certain assumptions that market participants
would use in pricing the asset or liability, including assumptions about risk and/or the risks inherent in the inputs to the valuation
technique. These inputs can be readily observable, market-corroborated, or generally unobservable inputs. The Company utilizes valuation
techniques that maximize the use of observable inputs and minimize the use of unobservable inputs. Based upon observable inputs used
in the valuation techniques, the Company is required to provide information according to the fair value hierarchy. The fair value hierarchy
ranks the quality and reliability of the information used to determine fair values into three broad levels as follows:
|
Level 1: |
Valuations for assets and
liabilities traded in active markets from readily available pricing sources for market transactions involving identical assets or
liabilities. |
|
|
|
|
Level 2: |
Valuations for assets and
liabilities traded in less active dealer or broker markets. Valuations are obtained from third-party pricing services for identical
or similar assets or liabilities. |
|
|
|
|
Level 3: |
Valuations incorporate
certain assumptions and projections in determining the fair value assigned to such assets or liabilities. |
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 June 30, 2024 | | |
Fair Value Measurements | |
| |
| | |
Fair | | |
As of June 30, 2024 | |
| |
Amount | | |
Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| | |
| |
Liabilities: | |
| | | |
| | | |
| | | |
| | | |
| | |
Contingent consideration: | |
| | | |
| | | |
| | | |
| | | |
| | |
Asuragen (1) | |
$ | 30 | | |
$ | 30 | | |
$ | - | | |
$ | - | | |
$ | 30 | |
Note payable: | |
| | | |
| | | |
| | | |
| | | |
| | |
BroadOak loan | |
| 7,400 | | |
| 6,784 | | |
| - | | |
| - | | |
| 6,784 | |
| |
$ | 7,430 | | |
$ | 6,814 | | |
$ | - | | |
$ | - | | |
$ | 6,814 | |
| |
As of December 31, 2023 | | |
Fair Value Measurements | |
| |
Carrying | | |
Fair | | |
As of December 31, 2023 | |
| |
Amount | | |
Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Liabilities: | |
| | | |
| | | |
| | | |
| | | |
| | |
Contingent consideration: | |
| | | |
| | | |
| | | |
| | | |
| | |
Asuragen (1) | |
$ | 453 | | |
$ | 453 | | |
$ | - | | |
$ | - | | |
$ | 453 | |
Note payable: | |
| | | |
| | | |
| | | |
| | | |
| | |
BroadOak loan | |
| 10,000 | | |
| 9,343 | | |
| - | | |
| - | | |
| 9,343 | |
| |
$ | 10,453 | | |
$ | 9,796 | | |
$ | - | | |
$ | - | | |
$ | 9,796 | |
In
connection with the acquisition of certain assets from Asuragen, Inc., the Company recorded contingent consideration related to contingent
payments and other revenue-based payments. The Company determined the fair value of the contingent consideration based on a probability-weighted
income approach derived from revenue estimates. The fair value measurement is based on significant inputs not observable in the market
and thus represents a Level 3 measurement.
In
connection with the Term 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.
A
roll forward of the carrying value of the Contingent Consideration Liability and BroadOak Loan to June 30, 2024 is as follows:
SCHEDULE
OF FAIR VALUE, ASSETS MEASURED ON RECURRING BASIS, UNOBSERVABLE INPUT RECONCILIATION
| |
| | |
| | |
| | |
| | |
Adjustment | | |
| |
| |
December 31,
2023 | | |
Payments | | |
Transferred
to Accrued
Expenses | | |
Accretion/
Interest Accrued | | |
to Fair Value/
Mark to
Market | | |
June 30,
2024 | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Asuragen | |
$ | 453 | | |
$ | - | | |
$ | (453 | ) | |
$ | 30 | | |
$ | - | | |
$ | 30 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
BroadOak loans | |
| 9,343 | | |
| (2,600 | ) | |
| - | | |
| - | | |
| 41 | | |
| 6,784 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
$ | 9,796 | | |
$ | (2,600 | ) | |
$ | (453 | ) | |
$ | 30 | | |
$ | 41 | | |
$ | 6,814 | |
Certain
of the Company’s non-financial assets, such as 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.
7. LEASES
The
table below presents the lease-related assets and liabilities recorded in the Condensed Consolidated Balance Sheet:
SCHEDULE
OF LEASE RELATED ASSETS AND LIABILITIES
| |
Classification on the Balance Sheet | |
June 30, 2024 | | |
December 31, 2023 | |
| |
| |
| | |
| |
Assets | |
| |
| | | |
| | |
Operating lease assets | |
Operating lease right of use assets | |
| 1,635 | | |
| 1,864 | |
Total lease assets | |
| |
$ | 1,635 | | |
$ | 1,864 | |
| |
| |
| | | |
| | |
Liabilities | |
| |
| | | |
| | |
Current | |
| |
| | | |
| | |
Operating lease liabilities | |
Other accrued expenses | |
| 319 | | |
| 377 | |
Total current lease liabilities | |
| |
$ | 319 | | |
$ | 377 | |
Noncurrent | |
| |
| | | |
| | |
Operating lease liabilities | |
Operating lease liabilities, net of current portion | |
| 1,286 | | |
| 1,472 | |
Total long-term lease liabilities | |
| |
| 1,286 | | |
| 1,472 | |
Total lease liabilities | |
| |
$ | 1,605 | | |
$ | 1,849 | |
The
weighted average remaining lease term for the Company’s operating leases was 3.9 years as of June 30, 2024 and the weighted average
discount rate for those leases was 11.9%. Total operating lease expense from continuing operations under these agreements for both the three months ended June
30, 2024 and 2023 was approximately $0.2 million and for the six months ended June 30, 2024 and 2023 was approximately $0.3 million
and $0.4 million, respectively. Total cash paid under these agreements for both the six months ended June 30, 2024 and 2023 was approximately
$0.4 million, respectively. The Company’s operating lease expenses are recorded within “Cost of revenue”
and “General and administrative expenses.”
The
table below reconciles the cash flows to the lease liabilities recorded on the Company’s Condensed Consolidated Balance Sheet as
of June 30, 2024:
SCHEDULE
OF MATURITIES OF OPERATING LEASE LIABILITIES
| |
Operating Leases | |
2024 - remaining six months | |
$ | 268 | |
2025 | |
| 450 | |
2026 | |
| 500 | |
2027 | |
| 550 | |
2028 | |
| 275 | |
Total minimum lease payments | |
| 2,043 | |
Less: amount of lease payments representing effects of discounting | |
| 438 | |
Present value of future minimum lease payments | |
| 1,605 | |
Less: current obligations under leases | |
| 319 | |
Long-term lease obligations | |
$ | 1,286 | |
8. COMMITMENTS AND CONTINGENCIES
Litigation
From
time to time, the Company may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business.
When the Company is aware of a claim or potential claim, it assesses the likelihood of any loss or exposure. If it is probable that a
loss will result and the amount of the loss can be reasonably estimated, the Company will record a liability for the loss. In addition
to the estimated loss, the recorded liability includes probable and estimable legal costs associated with the claim or potential claim.
Litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may
harm the Company’s business. There is no pending litigation involving the Company at this time.
Due
to the nature of the businesses in which the Company is engaged, it is subject to certain risks. Such risks include, among others, risk
of liability for personal injury or death to persons using products or services that the Company promotes or commercializes. There can
be no assurance that substantial claims or liabilities will not arise in the future due to the nature of the Company’s business
activities. There is also the risk of employment related litigation and other litigation in the ordinary course of business.
The
Company could also be held liable for errors and omissions of its employees in connection with the services it performs that are outside
the scope of any indemnity or insurance policy. The Company could be materially adversely affected if it were required to pay damages
or incur defense costs in connection with a claim that is outside the scope of an indemnification agreement; if the indemnity, although
applicable, is not performed in accordance with its terms; or if the Company’s liability exceeds the amount of applicable insurance
or indemnity.
9. OTHER ACCRUED EXPENSES
Other
accrued expenses consisted of the following as of June 30, 2024 and December 31, 2023:
SCHEDULE OF OTHER ACCRUED EXPENSES
| |
June 30, 2024 | | |
December 31, 2023 | |
Accrued royalties | |
$ | 7,010 | | |
$ | 6,268 | |
Contingent consideration | |
| 30 | | |
| 453 | |
Operating lease liability | |
| 319 | | |
| 377 | |
Accrued sales and marketing - diagnostics | |
| 28 | | |
| 43 | |
Accrued lab costs - diagnostics | |
| 103 | | |
| 68 | |
Accrued professional fees | |
| 162 | | |
| 241 | |
Taxes payable | |
| 308 | | |
| 261 | |
All others | |
| 622 | | |
| 490 | |
Total other accrued expenses | |
$ | 8,582 | | |
$ | 8,201 | |
10. STOCK-BASED COMPENSATION
Historically,
stock options have been granted with an exercise price equal to the market value of the common stock on the date of grant, with expiration
10 years from the date they are granted, and generally vest over a one to three-year period for employees and members of the Board. Upon
exercise, new shares will be issued by the Company. The restricted shares and restricted stock units (“RSUs”) granted to
Board members and employees generally have a three-year graded vesting period and are subject to accelerated vesting and forfeiture under
certain circumstances.
There
were no stock option awards issued during the six months ended June 30, 2024 and June 30, 2023.
The
Company recognized approximately $0.1 million and $0.2 million of stock-based compensation expense within continuing operations during
the three-month periods ended June 30, 2024 and 2023, respectively and approximately $0.1 million and $0.3 million for the six-month
periods ended June 30, 2024 and 2023, respectively. The following table has a breakout of stock-based compensation expense from continuing
operations by line item.
SCHEDULE OF SHARE-BASED COMPENSATION ARRANGEMENTS BY SHARE-BASED PAYMENT AWARD
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Cost of revenue | |
$ | - | | |
$ | 12 | | |
$ | 4 | | |
$ | 26 | |
Sales and marketing | |
| 23 | | |
| 30 | | |
| 53 | | |
| 60 | |
General and administrative | |
| 30 | | |
| 115 | | |
| 75 | | |
| 263 | |
Total stock compensation expense | |
$ | 53 | | |
$ | 157 | | |
$ | 132 | | |
$ | 349 | |
11. INCOME TAXES
Generally,
accounting standards require companies to provide for income taxes each quarter based on their estimate of the effective tax rate for
the full year. The authoritative guidance for accounting for income taxes allows use of the discrete method when it provides a better
estimate of income tax expense. Due to the Company’s valuation allowance position, it is the Company’s position that the
discrete method provides a more accurate estimate of income tax expense and therefore income tax expense for the current quarter has
been presented using the discrete method. As the year progresses, the Company refines its estimate based on the facts and circumstances
by each tax jurisdiction. The following table summarizes income tax expense on income from continuing operations and the effective tax
rate for the three- and six-month periods ended June 30, 2024 and 2023:
SCHEDULE OF EFFECTIVE INCOME TAX RATE
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Provision for income tax | |
$ | 4 | | |
$ | 4 | | |
$ | 8 | | |
$ | 8 | |
Effective income tax rate | |
| 0.2 | % | |
| 1.0 | % | |
| 0.3 | % | |
| 1.0 | % |
Income
tax expense for both periods was primarily due to state franchise taxes.
Other
long-term liabilities consisted of uncertain tax positions as of June 30, 2024 and December 31, 2023.
12. SEGMENT INFORMATION
We
operate under one segment which is the business of developing and selling clinical services.
13. NOTES PAYABLE
BroadOak
Loan
On
October 29, 2021, the Company and its subsidiaries entered into the Term Loan with BroadOak, providing for a term loan in the aggregate
principal amount of $8,000,000. Funding of the Term Loan took place on November 1, 2021. The Term Loan was scheduled to mature 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 was subordinate
to the Company’s $7,500,000 revolving credit facility with Comerica Bank. See Note 16, Revolving Line of Credit. The Term Loan
had an origination fee of 3% of the Term Loan amount, and a terminal payment equal to (i) 15% of the original principal amount of the
Term Loan if the change of control occurs on or prior to the first anniversary of the funding of the Term Loan, (ii) 20% of the original
principal amount of the Term Loan if the change of control occurs after the first anniversary but on or prior to the second anniversary
of the funding of the Term Loan and (iii) 30% of the original principal amount of the Term Loan if the change of control occurs after
the second anniversary of the funding of the Term Loan, or if the Term Loan is repaid on its maturity date.
The
Term Loan 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 Term Loan also contains customary events of default.
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 stockholders’ deficit. Accordingly, the Company elected the fair value option for the Note.
In
May 2022, the Company issued a convertible note to BroadOak, pursuant to which BroadOak funded a term loan in the aggregate principal
amount of $2.0 million, which was converted into a subordinated term loan and was added to the outstanding balance of the Term Loan.
On
October 24, 2023, the Company entered into a Second Amendment to Loan and Security Agreement (the “Second Amendment”) with
BroadOak. The primary changes to the original Term Loan were as follows:
|
● |
The Company made a one-time
payment in an aggregate amount equal to $2,500,000, on October 30, 2023 and applied the payment in full satisfaction of the $3,000,000
Terminal Payment (as defined in the Term Loan). See above regarding the Terminal Payment. |
|
● |
Effective November 1, 2023,
the interest rate under the Term Loan was reduced from 9% to 8% through the maturity date of October 31, 2024 or earlier, upon the
occurrence of a change in control (“Loan Maturity Date”). |
|
|
|
|
● |
The Company had the option
to request an extension of the Loan Maturity Date in writing no less than sixty days prior to the Loan Maturity Date. If BroadOak
agreed to the extension, the Loan Maturity Date would automatically be extended. |
On
March 29, 2024, the Company entered into a Third Amendment to Loan and Security Agreement with BroadOak (the “Third Amendment”).
The primary changes to the Second Amendment were as follows:
|
● |
The maturity date was extended
to June 30, 2025. |
|
● |
Beginning April 1, 2024,
the Company will make $500,000 monthly payments with the remaining loan balance due on the new maturity date. |
The
Third Amendment was treated as a debt modification which is accounted for prospectively. Since the Term Loan is carried at fair value
under the fair value option, the Second Amendment did not result in any extinguishment gain or loss upon amendment, and the impact of
the revised terms was incorporated into the Company’s first quarter 2024 fair value calculation.
The
balance of the loan outstanding at June 30, 2024 was $7.4 million.
14. SUPPLEMENTAL CASH FLOW INFORMATION
Supplemental
Disclosures of Non-Cash Activities
(in
thousands)
SUPPLEMENTAL CASH FLOW INFORMATION
| |
2024 | | |
2023 | |
| |
Six Months Ended | |
| |
June 30, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Taxes accrued for repurchase of restricted shares | |
$ | 16 | | |
$ | 9 | |
Purchase of property and equipment included in accounts payable | |
| 230 | | |
| 29 | |
15. MEZZANINE EQUITY
Redeemable
Preferred Stock
On
January 10, 2020, the Company entered into a Securities Purchase and Exchange Agreement (the “Securities Purchase and Exchange
Agreement”) with 1315 Capital and Ampersand (collectively, the “Investors”) pursuant to which the Company agreed to
sell to the Investors an aggregate of $20.0 million in Series B Preferred Stock of the Company, at an issuance price per share of $1,000
(“New Investment Shares”). Pursuant to the Securities Purchase and Exchange Agreement, 1315 Capital agreed to purchase 19,000
shares of Series B Preferred Stock at an aggregate purchase price of $19.0 million and Ampersand agreed to purchase 1,000 shares of Series
B Preferred Stock at an aggregate purchase price of $1.0 million.
In
addition, the Company agreed to exchange $27.0 million of the Company’s existing Series A convertible preferred stock, par value
$0.01 per share, held by Ampersand (the “Series A Preferred Stock”), represented by 270 shares of Series A Preferred Stock
with a stated value of $100,000 per share, which represents all of the Company’s issued and outstanding Series A Preferred Stock,
for 27,000 newly issued shares of Series B Preferred Stock (such shares of Series B Preferred Stock, the “Exchange Shares”
and such transaction, the “Exchange”). Following the Exchange, no shares of Series A Preferred Stock remained designated,
authorized, issued or outstanding. The Series B Preferred Stock has a conversion price of $6.00.
Voting
On
any matter presented to the stockholders of the Company for their action or consideration at any meeting of stockholders of the Company
(or by written consent of stockholders in lieu of meeting), each holder of outstanding shares of Series B Preferred Stock will be entitled
to cast the number of votes equal to the number of whole shares of the Company’s common stock into which the shares of Series B
Preferred Stock held by such holder are convertible as of the record date for determining stockholders entitled to vote on such matter.
Except as provided by law or by the Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred
Stock (the “Certificate of Designation”), holders of Series B Preferred Stock will vote together with the holders of common
stock as a single class and on an as-converted to common stock basis.
Director
Designation Rights
The
Certificate of Designation also provides each Investor with the following director designation rights: for so long such Investor holds
at least sixty percent (60%) of the Series B Preferred Stock issued to it on the Issuance Date (as defined therein), such Investor will
be entitled to elect two directors to the Company’s Board of Directors (the “Board”), provided that one of the directors
qualifies as an “independent director” under Rule 5605(a)(2) of the listing rules of the Nasdaq Stock Market (or any successor
rule or similar rule promulgated by another exchange on which the Company’s securities are then listed or designated) (“Independent
Director”). However, if at any time such Investor holds less than sixty percent (60%), but at least forty percent (40%), of the
Series B Preferred Stock issued to them on the Issuance Date, such Investor would only be entitled to elect one director to the Board.
Any director elected pursuant to the terms of the Certificate of Designation may be removed without cause by, and only by, the affirmative
vote of the holders of Series B Preferred Stock. A vacancy in any directorship filled by the holders of Series B Preferred Stock may
be filled only by vote or written consent in lieu of a meeting of such holders of Series B Preferred Stock or by any remaining director
or directors elected by such holders of Series B Preferred Stock.
On
November 15, 2023, Edward Chan, a director designated by 1315 Capital to the Board, provided notice to the Company of his resignation
from the Board, effective immediately. Further, on December 7, 2023, Robert Gorman, a director designated by Ampersand to the Board,
provided notice to the Company of his resignation as a director and as Chairman of the Board, effective immediately.
As
of the date of this report, each of 1315 Capital and Ampersand has appointed one director to the Board, and each has not appointed a
second director to the Board.
Conversion
The
Certificate of Designation provides that from and after the Issuance Date and subject to the terms of the Certificate of Designation,
each share of Series B Preferred Stock is convertible, at any time and from time to time, at the option of the holder into a number of
shares of common stock equal to dividing the amount equal to the greater of the Stated Value of such Series B Preferred Stock, plus any
dividends declared but unpaid thereon, or such amount per share as would have been payable had each such share been converted into common
stock immediately prior to a liquidation, by six dollars ($6.00) (subject to adjustment in the event of any stock dividend, stock split,
combination, or other similar recapitalization affecting such shares). The aggregate number of shares of common stock that may be issued
through conversion of all of the New Investment Shares and Exchange Shares is 7,833,334 shares (subject to appropriate adjustment in
the event of any stock dividend, stock split, combination or other similar recapitalization affecting such shares).
Mandatory
Conversion
If
the Company consummates the sale of shares of common stock to the public in a firm-commitment underwritten public offering pursuant to
an effective registration statement under the Securities Act pursuant to which the price of the common stock in such offering is at least
equal to twelve dollars ($12.00) (subject to adjustment in the event of any stock dividend, stock split, combination, or other similar
recapitalization affecting such shares) and such offering does not include warrants (or any other convertible security) and results in
at least $25,000,000 in proceeds, net of the underwriting discount and commissions, to the Company, and the common stock continues to
be listed for trading on the Nasdaq Capital Market or another exchange, all outstanding shares of Series B Preferred Stock will automatically
be converted into shares of common stock, at the then effective Series B Conversion Ratio (as defined in the Certificate of Designation).
Liquidation
Upon
any voluntary or involuntary liquidation, dissolution or winding up of the Company or Deemed Liquidation (as defined in the Certificate
of Designation) (a “Liquidation”), the holders of shares of Series B Preferred Stock then outstanding will be entitled to
be paid out of the assets of the Company available for distribution to its stockholders (on a pari passu basis with the holders of any
class or series of preferred stock ranking on liquidation on a parity with the Series B Preferred Stock), and before any payment will
be made to the holders of common stock or any other class or series of preferred stock ranking on liquidation junior to the Series B
Preferred Stock by reason of their ownership thereof, an amount per share of Series B Preferred Stock equal to the greater of (i) the
Stated Value of such share of Series B Preferred Stock, plus any dividends declared but unpaid thereon, or (ii) such amount per share
as would have been payable had each such share been converted into common stock immediately prior to such Liquidation.
As
of June 30, 2024 and December 31, 2023, there were 47,000 issued and outstanding shares of Series B Preferred Stock, respectively.
16. REVOLVING LINE OF CREDIT
On
October 13, 2021, the Company and its subsidiaries entered into the Comerica Loan Agreement with Comerica, providing for a revolving
credit facility of up to $7,500,000 (the “Credit Facility”). The Company could use the proceeds of the Credit Facility for
working capital and other general corporate purposes.
On
October 6, 2023, effective September 30, 2023, the Company entered into a Fifth Amendment to its Loan and Security Agreement (the “Fifth
Amendment to the Comerica Loan Agreement”) with Comerica Bank providing for a revolving credit facility of up to $5,000,000.
In
February 2024, the Company terminated the Comerica Loan Agreement. The Company did not owe anything outstanding on the line of credit
at the time of termination and does not owe anything further to Comerica.
17. RECENT ACCOUNTING STANDARDS
Accounting
Pronouncements Adopted
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 ASU 2020-06 amendments are effective for fiscal years beginning after December 15, 2023, and interim
periods within those fiscal years. This was adopted on January 1, 2024 and there was no impact upon adoption.
Accounting
Pronouncements Pending
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This ASU requires public
entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income
taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption
permitted. The Company is currently evaluating the impact the adoption of this standard on its financial statements.
INTERPACE
BIOSCIENCES, INC
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
FORWARD-LOOKING
STATEMENTS
This
quarterly report on Form 10-Q contains “forward-looking statements” within the meaning of Section 27A of the Securities Act
of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”). Statements that are not historical facts, including statements about our plans, objectives, beliefs and expectations, are
forward-looking statements. Forward-looking statements include statements preceded by, followed by or that include the words “believes,”
“expects,” “anticipates,” “plans,” “estimates,” “intends,” “projects,”
“should,” “could,” “may,” “will” or similar words and expressions. These forward-looking
statements are contained throughout this Form 10-Q.
Forward-looking
statements are only predictions and are not guarantees of future performance. These statements are based on current expectations and
assumptions involving judgments about, among other things, future economic, competitive and market conditions and future business decisions,
all of which are difficult or impossible to predict accurately and many of which are beyond our control. These predictions are also affected
by known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from those expressed
or implied by any forward-looking statement. Many of these factors are beyond our ability to control or predict. Our actual results could
differ materially from the results contemplated by these forward-looking statements due to a number of factors. Such factors include,
but are not limited to, the following:
|
● |
our history of operating
losses prior to fiscal 2023; |
|
|
|
|
● |
our expectations of future
revenues, expenditures, capital or other funding requirements; |
|
|
|
|
● |
our reliance on Medicare
reimbursement for our clinical services and our being subject to decisions of the Center for Medicare and Medicaid Services (“CMS”)
regarding reimbursement and pricing of our clinical services which could have a material adverse effect on our business and financial
results; |
|
|
|
|
● |
our ability to continue
to perform, bill and receive reimbursement for our PancraGEN® molecular test long-term under the existing local coverage
determination (“LCD”), given that such LCD is currently under review by Novitas, the Company’s Medicare administrative
contractor; |
|
|
|
|
● |
our secured lender has
the right to foreclose on substantially all of our assets if we are unable to timely repay our outstanding obligations; |
|
|
|
|
● |
our dependence on sales
and reimbursements from our clinical services for all of our revenue; |
|
|
|
|
● |
the ability to continue
to generate sufficient revenue from our clinical service products and other products and/or solutions that we develop in the future
is important for our ability to meet our financial and other targets; |
|
|
|
|
● |
our ability to finance
our business on acceptable terms in the future, which may limit the ability to grow our business, develop and commercialize products
and services, develop and commercialize new molecular clinical service solutions and technologies; |
|
|
|
|
● |
our obligations to make
royalty and milestone payments to our licensors; |
|
● |
our dependence on third
parties for the supply of some of the materials used in our clinical services tests; |
|
● |
the potential adverse impact
of current and future laws, licensing requirements and governmental regulations upon our business operations, including but not limited
to the evolving U.S. regulatory environment related to laboratory developed tests (“LDTs”), pricing of our tests and
services and patient access limitations; |
|
|
|
|
● |
our reliance on our sales
and marketing activities for future business growth and our ability to continue to expand our sales and marketing activities; |
|
|
|
|
● |
our being subject to the
controlling interests of our two private equity investors who control, on an as-converted basis, an aggregate of 64.2% of our outstanding
shares of common stock through their holdings of our Series B Preferred Stock, and this concentration of ownership along with their
authority for designation rights for a majority of our directors and their right to approve certain of our actions has a substantial
influence on our decisions; |
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● |
the delisting of our common
stock from Nasdaq has adversely affected and may continue to adversely affect our common stock and business and financial condition; |
|
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● |
geopolitical and other
economic and political conditions or events (such as the wars in Ukraine and Israel/Gaza); |
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● |
our ability to implement
our business strategy; and |
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● |
the potential impact of
existing and future contingent liabilities on our financial condition. |
Please
see Part I – Item 1A – “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31,
2023 filed with the SEC on April 1, 2024, and as amended on April 26, 2024, as well as other documents we file with the SEC from time-to-time,
for other important factors that could cause our actual results to differ materially from our current expectations as expressed in the
forward-looking statements discussed in this Form 10-Q. Because of these and other risks, uncertainties and assumptions, you should not
place undue reliance on these forward-looking statements. In addition, these statements speak only as of the date of the report in which
they are set forth and, except as may be required by law, we undertake no obligation to revise or update publicly any forward-looking
statements for any reason.
OVERVIEW
We
are a fully integrated commercial company that provides molecular diagnostics, bioinformatics and pathology services for evaluation of
risk of cancer by leveraging the latest technology in personalized medicine for improved patient diagnosis and management. We develop
and commercialize genomic tests and related first line assays principally focused on early detection of patients with indeterminate biopsies
and at high risk of cancer using the latest technology.
Impact
of Our Reliance on CMS and Novitas
Along
with many laboratories, we may be affected by the Proposed LCD DL39365, which is currently under consideration by our local Medicare
Administrative Contractor, Novitas. If finalized, this Proposed LCD, which governs “Genetic Testing for Oncology,” could
impact the existing Medicare coverage for one of our molecular tests, PancraGEN®. On June 5, 2023 we announced that
Novitas issued the final LCD of Genetic Testing for Oncology (L39365) which, if finalized, would have established non-coverage for
the Company’s widely used PancraGEN® test effective July 17, 2023. On July 6, 2023, Novitas announced that it
would not be implementing the final Genetic Testing for Oncology LCD (L39365) as scheduled on July 17, 2023. Novitas then issued a
new virtually identical proposed LCD affecting the same companies and tests and reaching the same conclusions as noted in the
previously rescinded LCD on July 27, 2023. In response, the Company participated in a public meeting presentation and submitted
detailed written comments supporting the use of PancraGEN®. The timing and content of any final implemented LCD is
uncertain at this time; the process could potentially take a year or longer from issuance of the updated proposed LCD to reach a
conclusion. On July 29, 2024 the Company announced that CMS granted Novitas an undefined extension to the final decision
for the LCD. As a result, we are able to continue offering PancraGEN® and the related Point2® fluid
chemistry tests for amylase, CEA, and glucose. In the event Novitas ultimately restricts coverage for the PancraGEN®
test, the Company’s liquidity could be negatively impacted.
U.S.
Food and Drug Administration Regulation of LDTs
While
subject to oversight by CMS through its enforcement of the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”), the
Food and Drug Administration (“FDA”) has claimed regulatory authority over laboratories that produce LDTs, a type of in vitro
diagnostic test that is designed, manufactured and used within a single laboratory. The FDA has regulatory responsibility over, among
other areas, instruments, test kits, reagents and other devices used in clinical laboratories to perform diagnostic testing in the United
States.
Historically,
the FDA has exercised enforcement discretion over most LDTs. On April 29, 2024, however, the FDA published a final rule on LDTs, in which
FDA outlines its plans to end enforcement discretion for many LDTs in five stages over a four-year period. In Phase 1 (effective May
6, 2025), clinical laboratories running LDTs will be required to comply with medical device (adverse event) reporting and correction/removal
reporting requirements, as well as requirements for maintenance of complaint files under the FDA’s quality systems regulation (QSR).
In Phase 2 (effective May 6, 2026), clinical laboratories will be required to comply with all other device requirements (e.g., registration/listing,
labeling, investigational use), except for the remaining QSR requirements and premarket review. In Phase 3 (effective May 6, 2027), clinical
laboratories will be required to comply with all remaining applicable QSR requirements. In Phase 4 (effective ~November 6, 2027), clinical
laboratories will be required to comply with premarket review requirements for high-risk tests (i.e., tests subject to the premarket
approval (PMA) requirement). Finally, in Phase 5 (effective May 6, 2028), clinical laboratories will be required to comply with premarket
review requirements for moderate- and low-risk tests (i.e., tests subject to the de novo or 510(k) requirement).
Under
the final rule, several types of tests will be eligible for some degree of continued enforcement discretion. For example, LDTs approved
by the New York State Department of Health will be exempt from premarket review requirements but will remain subject to the requirements
of Phases 1 through 3. Similarly, LDTs first marketed prior to May 6, 2024 that are not subsequently modified, or are modified only in
certain limited ways, will be exempt from the premarket review and most quality systems requirements, but will remain subject to the
requirements of Phases 1 and 2. The FDA notes, however, that it retains discretion to pursue enforcement action for violations of the
Federal Food, Drug and Cosmetic Act at any time and intends to do so when appropriate. The FDA further explains that it may update any
of the enforcement discretion policies set forth in the final rule as circumstances warrant or if the circumstances that inform those
policies change, consistent with the FDA’s good guidance practices.
To
the extent the FDA ultimately regulates certain LDTs, our LDTs may be subject to certain additional regulatory requirements. Complying
with the FDA’s requirements can be expensive, time-consuming, and subject us to significant or unanticipated delays. Insofar as
we may be required to obtain premarket clearance or approval to perform or continue performing an LDT, we cannot assure you that we will
be able to obtain such authorization. Even if we obtain regulatory clearance or approval where required, such authorization may not be
for the intended uses that we believe are commercially attractive or are critical to the commercial success of our tests. As a result,
the application of the FDA’s requirements to our tests could materially and adversely affect our business, financial condition,
and results of operations.
Failure
to comply with applicable requirements could result in a range of enforcement actions by the FDA, such as warning letters, civil monetary
penalties, injunctions, criminal prosecution, recall or seizure, operating restrictions, partial suspension or total shutdown of operations,
and denial of or challenges to applications for clearance or approval, as well as significant adverse publicity.
Legislative
proposals have also been introduced that, if enacted, would potentially supersede the final rule. In March 2017, members of Congress
posted a discussion draft of “The Diagnostics Accuracy and Innovation Act”. The discussion draft included language that,
if enacted, would have established a new regulatory framework for the oversight of in vitro clinical tests (“IVCTs”) which
include LDTs. In March 2020, members of Congress introduced “The Verifying Accurate, Leading-edge IVCT Development (VALID) Act.”
This bill has been re-introduced in substantially similar forms over the years, and, most recently in March 2023. Under the most recent
version of the VALID Act, a risk-based approach would be used to regulate IVCTs while grandfathering many existing IVCTs from certain
requirements. Each test will be classified as high-risk, moderate-risk, or low-risk. Pre-market review will be required for high-risk
tests. To market a high-risk IVCT, reasonable assurance of analytical and clinical validity for the intended use must be established.
Under VALID, a precertification process would be established which will allow a laboratory to establish that the facilities, methods,
and controls used in the development of certain IVCTs meet quality system requirements. If pre-certified, IVCTs falling within the scope
of a certification order will not be subject to pre-market review. The new regulatory framework would include quality control and post-market
reporting requirements. The FDA would have the authority to withdraw from the market IVCTs if there is a reasonable likelihood that such
tests will cause death or serious adverse health consequences (among other criteria). Failure to comply with applicable regulatory requirements
could result in enforcement action by the FDA, such as fines, product suspensions, warning letters, recalls, injunctions and other civil
and criminal sanctions. However, we cannot predict if this (or any other bill) will be enacted in its current (or any other) form and
cannot quantify the effect of such proposals on our business.
Whether
via statute, regulation, or sub-regulatory action, any FDA effort to end enforcement discretion for LDTs is likely to continue to be
met with resistance by certain sections of industry. On May 29, 2024, the American Clinical Laboratory Association filed a lawsuit challenging
the April 2024 LDT final rule, in which the plaintiffs argue that FDA lacks authority to regulate LDTs as medical devices. We cannot
predict the likelihood of success of this or any other such actions, nor can we quantify the effect of such efforts on our business.
Revenue
Recognition
Clinical
services derive revenues from the performance of proprietary assays or tests. Our performance obligation is fulfilled upon completion,
review and release of test results to the customer, at which time we bill third-party payers or direct-bill payers for the tests performed.
Under Accounting Standards Codification 606, revenue is recognized based upon the estimated transaction price or net realizable value
(“NRV”), which is determined based on historical collection rates by each payer category for each proprietary test offered.
To the extent that the transaction price includes variable consideration, for all third party and direct-bill payers and proprietary
tests, we estimate the amount of variable consideration that should be included in the transaction price using the expected value method
based on historical experience.
The
ultimate amounts received from the third-party and direct-bill payers and related estimated reimbursement rates are regularly reviewed
and we adjust the NRV’s and related contractual allowances accordingly. If actual collections and related NRV’s vary significantly
from our estimates, we adjust the estimates of contractual allowances, which affects net revenue in the period such variances become
known.
Cost
of Revenue
Cost
of revenue consists primarily of the costs associated with operating our laboratory and other costs directly related to our tests. Personnel
costs, which constitute the largest portion of cost of services, include all labor-related costs, such as salaries, bonuses, fringe benefits
and payroll taxes for laboratory personnel. Other direct costs include, but are not limited to, laboratory supplies, certain consulting
expenses, royalty expenses, and facility expenses.
CONDENSED
CONSOLIDATED RESULTS OF OPERATIONS
The
following table sets forth, for the periods indicated, certain statements of operations data. The trends illustrated in this table may
not be indicative of future results.
Condensed
Consolidated Results of Continuing Operations for the Quarter Ended June 30, 2024 Compared to the Quarter Ended June 30, 2023 (unaudited,
in thousands)
| |
Three Months Ended June 30, | |
| |
2024 | | |
2024 | | |
2023 | | |
2023 | |
| |
| | |
% to | | |
| | |
% to | |
| |
| | |
revenue | | |
| | |
revenue | |
| |
| | |
| | |
| | |
| |
Revenue, net | |
$ | 12,042 | | |
| 100.0 | % | |
$ | 11,026 | | |
| 100.0 | % |
Cost of revenue | |
| 4,611 | | |
| 38.3 | % | |
| 4,191 | | |
| 38.0 | % |
Gross profit | |
| 7,431 | | |
| 61.7 | % | |
| 6,835 | | |
| 62.0 | % |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Sales and marketing | |
| 2,887 | | |
| 24.0 | % | |
| 2,605 | | |
| 23.6 | % |
Research and development | |
| 146 | | |
| 1.2 | % | |
| 186 | | |
| 1.7 | % |
General and administrative | |
| 2,141 | | |
| 17.8 | % | |
| 2,894 | | |
| 26.2 | % |
Acquisition related amortization expense | |
| - | | |
| 0.0 | % | |
| 318 | | |
| 2.9 | % |
Total operating expenses | |
| 5,174 | | |
| 43.0 | % | |
| 6,003 | | |
| 54.4 | % |
| |
| | | |
| | | |
| | | |
| | |
Operating income | |
| 2,257 | | |
| 18.7 | % | |
| 832 | | |
| 7.5 | % |
Interest accretion expense | |
| (12 | ) | |
| -0.1 | % | |
| (31 | ) | |
| -0.3 | % |
Note payable interest | |
| (176 | ) | |
| -1.5 | % | |
| (228 | ) | |
| -2.1 | % |
Other income (expense), net | |
| 71 | | |
| 0.6 | % | |
| (174 | ) | |
| -1.6 | % |
Income from continuing operations before tax | |
| 2,140 | | |
| 17.8 | % | |
| 399 | | |
| 3.6 | % |
Provision for income taxes | |
| 4 | | |
| 0.0 | % | |
| 4 | | |
| 0.0 | % |
Income from continuing operations | |
| 2,136 | | |
| 17.7 | % | |
| 395 | | |
| 3.6 | % |
| |
| | | |
| | | |
| | | |
| | |
Loss from discontinued operations, net of tax | |
| (74 | ) | |
| -0.6 | % | |
| (220 | ) | |
| -2.0 | % |
| |
| | | |
| | | |
| | | |
| | |
Net income | |
$ | 2,062 | | |
| 17.1 | % | |
$ | 175 | | |
| 1.6 | % |
Revenue,
net
Revenue,
net for the three months ended June 30, 2024 increased by $1.0 million, or 9%, to $12.0 million, compared to $11.0 million for the three
months ended June 30, 2023. The increase in net revenue was largely driven by increased test volumes as compared to the prior year.
Cost
of revenue
Consolidated
cost of revenue for the three months ended June 30, 2024 was $4.6 million, as compared to $4.2 million for the three months ended
June 30, 2023. As a percentage of revenue, cost of revenue was approximately 38% for both the three months ended June 30, 2024 and the three months ended June 30, 2023.
Gross
profit
Consolidated
gross profit was approximately $7.4 million for the three months ended June 30, 2024 and $6.8 million for the three months ended June
30, 2023. The gross profit percentage was approximately 62% for both the three months ended June 30, 3024 and June 30, 2023, respectively.
Sales
and marketing expense
Sales
and marketing expense was approximately $2.9 million for the three months ended June 30, 2024 and $2.6 million for the three months ended
June 30, 2023. The increase was primarily attributable to increased headcount and related employee
costs. As a percentage of revenue, sales and marketing expense was approximately 24% in both periods.
Research
and development
Research
and development expense was approximately $0.1 million for the three months ended June 30, 2024 and $0.2 million for the three months
ended June 30, 2023. As a percentage of revenue, research and development expense decreased to 1% from 2% in the comparable prior year
period.
General
and administrative
General
and administrative expense was approximately $2.1 million for the three months ended June 30, 2024 and $2.9 million for the three months
ended June 30, 2023. The decrease can be primarily attributed to a decrease in legal and related
professional fees.
Acquisition
amortization expense
During
the three months ended June 30, 2023, we recorded amortization expense of approximately $0.3 million, which was related to intangible
assets associated with prior acquisitions. There was no amortization expense during the three months ended June 30, 2024.
Operating
income
Operating
income from continuing operations was $2.3 million for the three months ended June 30, 2024 as compared to operating income from continuing
operations of $0.8 million for the three months ended June 30, 2023. The increase in operating income from continuing operations was
primarily attributable to the increase in revenue and lower general and administrative expenses discussed above.
Provision
for income taxes
Income
tax expense was approximately $4,000 for both the three months ended June 30, 2024 and the three months ended June 30, 2023.
Loss
from discontinued operations, net of tax
We
had a loss from discontinued operations of approximately $0.1 million for the three months ended June 30, 2024 and a loss from discontinued
operations of approximately $0.2 million for the three months ended June 30, 2023.
Condensed
Consolidated Results of Continuing Operations for the Six Months Ended June 30, 2024 Compared to the Six Months Ended June 30, 2023 (unaudited,
in thousands)
| |
Six Months Ended June 30, | |
| |
2024 | | |
2024 | | |
2023 | | |
2023 | |
| |
| | |
% to | | |
| | |
% to | |
| |
| | |
revenue | | |
| | |
revenue | |
| |
| | |
| | |
| | |
| |
Revenue, net | |
$ | 22,314 | | |
| 100.0 | % | |
$ | 20,853 | | |
| 100.0 | % |
Cost of revenue | |
| 8,812 | | |
| 39.5 | % | |
| 8,039 | | |
| 38.6 | % |
Gross profit | |
| 13,502 | | |
| 60.5 | % | |
| 12,814 | | |
| 61.4 | % |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Sales and marketing | |
| 5,707 | | |
| 25.6 | % | |
| 4,947 | | |
| 23.7 | % |
Research and development | |
| 283 | | |
| 1.3 | % | |
| 335 | | |
| 1.6 | % |
General and administrative | |
| 4,381 | | |
| 19.6 | % | |
| 5,389 | | |
| 25.8 | % |
Acquisition related amortization expense | |
| - | | |
| 0.0 | % | |
| 635 | | |
| 3.0 | % |
Total operating expenses | |
| 10,371 | | |
| 46.5 | % | |
| 11,306 | | |
| 54.2 | % |
| |
| | | |
| | | |
| | | |
| | |
Operating income | |
| 3,131 | | |
| 14.0 | % | |
| 1,508 | | |
| 7.2 | % |
Interest accretion expense | |
| (30 | ) | |
| -0.1 | % | |
| (66 | ) | |
| -0.3 | % |
Note payable interest | |
| (373 | ) | |
| -1.7 | % | |
| (453 | ) | |
| -2.2 | % |
Other expense, net | |
| (12 | ) | |
| -0.1 | % | |
| (156 | ) | |
| -0.7 | % |
Income from continuing operations before tax | |
| 2,716 | | |
| 12.2 | % | |
| 833 | | |
| 4.0 | % |
Provision for income taxes | |
| 8 | | |
| 0.0 | % | |
| 8 | | |
| 0.0 | % |
Income from continuing operations | |
| 2,708 | | |
| 12.1 | % | |
| 825 | | |
| 4.0 | % |
| |
| | | |
| | | |
| | | |
| | |
Loss from discontinued operations, net of tax | |
| (178 | ) | |
| -0.8 | % | |
| (299 | ) | |
| -1.4 | % |
| |
| | | |
| | | |
| | | |
| | |
Net income | |
$ | 2,530 | | |
| 11.3 | % | |
$ | 526 | | |
| 2.5 | % |
Revenue,
net
Revenue,
net for the six months ended June 30, 2024 increased by $1.5 million, or 7%, to $22.3 million, compared to $20.9 million for the six
months ended June 30, 2023. The increase in net revenue was largely driven by increased test volumes as compared to the prior year.
Cost
of revenue
Consolidated
cost of revenue for the six months ended June 30, 2024 was $8.8 million, as compared to $8.0 million for the six months ended June 30,
2023. As a percentage of revenue, cost of revenue was approximately 40% for the six months ended June 30, 2024 as compared to 39% for
the six months ended June 30, 2023.
Gross
profit
Consolidated
gross profit was approximately $13.5 million for the six months ended June 30, 2024 and $12.8 million for the six months ended June 30,
2023. The gross profit percentage was approximately 60% for the six months ended June 30, 3024 and 61% for the six months ended June
30, 2023. The increase was primarily due to the increase in revenue discussed above.
Sales
and marketing expense
Sales
and marketing expense was approximately $5.7 million for the six months ended June 30, 2024 and $4.9 million for the six months ended
June 30, 2023. The increase was primarily due to increased employee costs. As a percentage of revenue, sales and marketing expense increased
to 26% from 24% in the comparable prior year period due to the increase in sales and marketing expense.
Research
and development
Research
and development expense was approximately $0.3 million for both the six months ended June 30, 2024 and June 30, 2023, respectively. As
a percentage of revenue, research and development expense decreased to 1% from 2% in the comparable prior year period.
General
and administrative
General
and administrative expense was approximately $4.4 million for the six months ended June 30, 2024 and $5.4 million for the three months
ended June 30, 2023. The decrease can be primarily attributed to a decrease in legal and related
professional fees.
Acquisition
amortization expense
During
the six months ended June 30, 2023, we recorded amortization expense of approximately $0.6 million, which was related to intangible assets
associated with prior acquisitions. There was no amortization expense during the six months ended June 30, 2024.
Operating
income
Operating
income from continuing operations was $3.1 million for the six months ended June 30, 2024 as compared to operating income from continuing
operations of $1.5 million for the six months ended June 30, 2023. The increase in operating income from continuing operations was primarily
attributable to the increase in revenue and lower general and administrative expenses discussed above.
Provision
for income taxes
Income
tax expense was approximately $8,000 for both the six months ended June 30, 2024 and June 30, 2023.
Loss
from discontinued operations, net of tax
We
had a loss from discontinued operations of approximately $0.2 million for the six months ended June 30, 2024 and a loss from discontinued
operations of approximately $0.3 million for the six months ended June 30, 2023.
Non-GAAP
Financial Measures
In
addition to the United States generally accepted accounting principles (“GAAP”), results provided throughout this document,
we have provided certain non-GAAP financial measures to help evaluate the results of our performance. We believe that these non-GAAP
financial measures, when presented in conjunction with comparable GAAP financial measures, are useful to both management and investors
in analyzing our ongoing business and operating performance. We believe that providing the non-GAAP information to investors, in addition
to the GAAP presentation, allows investors to view our financial results in the way that management views financial results.
In
this Quarterly Report on Form 10-Q, we discuss Adjusted EBITDA, a non-GAAP financial measure. Adjusted EBITDA is a metric used by management
to measure cash flow of the ongoing business. Adjusted EBITDA is defined as income or loss from continuing operations, plus depreciation
and amortization, non-cash stock based compensation, interest and taxes, and other non-cash expenses including change in fair value of
notes payable and warrant liability. The table below includes a reconciliation of this non-GAAP financial measure to the most directly
comparable GAAP financial measure.
Reconciliation
of Adjusted EBITDA (Unaudited)
($
in thousands)
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Income from continuing operations (GAAP Basis) | |
$ | 2,136 | | |
$ | 395 | | |
$ | 2,708 | | |
$ | 825 | |
Depreciation and amortization | |
| 67 | | |
| 357 | | |
| 119 | | |
| 714 | |
Stock-based compensation | |
| 53 | | |
| 157 | | |
| 132 | | |
| 349 | |
Taxes expense | |
| 4 | | |
| 4 | | |
| 8 | | |
| 8 | |
Interest accretion expense | |
| 12 | | |
| 31 | | |
| 30 | | |
| 66 | |
Note payable interest | |
| 176 | | |
| 228 | | |
| 373 | | |
| 453 | |
Interest income | |
| (14 | ) | |
| (13 | ) | |
| (29 | ) | |
| (13 | ) |
Change in fair value of note payable | |
| (57 | ) | |
| 165 | | |
| 41 | | |
| 142 | |
Adjusted EBITDA | |
$ | 2,377 | | |
$ | 1,324 | | |
$ | 3,382 | | |
$ | 2,544 | |
LIQUIDITY
AND CAPITAL RESOURCES
In
October 2021, the Company entered into a Loan and Security 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 was scheduled
to mature 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 was subordinate to the Company’s former $7,500,000 revolving credit facility with Comerica Bank. The Term Loan has an origination
fee of 3% of the Term Loan amount, and a terminal payment equal to (i) 15% of the original principal amount of the Term Loan if the change
of control occurs on or prior to the first anniversary of the funding of the Term Loan, (ii) 20% of the original principal amount of
the Term Loan if the change of control occurs after the first anniversary but on or prior to the second anniversary of the funding of
the Term Loan and (iii) 30% of the original principal amount of the Term Loan if the change of control occurs after the second anniversary
of the funding of the Term Loan, or if the Term Loan is repaid on its maturity date. Upon receipt of the term loan, the proceeds were
used to repay in full at their maturity the notes extended by Ampersand and 1315 Capital discussed above. See Note 13, Notes Payable,
for more details. In May 2022, the Company issued a Convertible Note to BroadOak, pursuant to which BroadOak funded a term loan in
the aggregate principal amount of $2.0 million which was converted into a subordinated term loan and was added to the outstanding balance of the Term Loan. See Note 13, Notes Payable, for more details.
On
October 24, 2023, the Company entered into a Second Amendment to the Loan and Security Agreement with BroadOak (the “Second Amendment”).
The primary changes to the Term Loan were as follows:
|
● |
The Company made a one-time
payment in an aggregate amount equal to $2,500,000, on October 30, 2023 and applied the payment in full satisfaction of the $3,000,000
Terminal Payment (as defined in the Term Loan). See Note 13, Notes Payable, regarding the Terminal Payment. |
|
|
|
|
● |
Effective November 1, 2023,
the interest rate under the Term Loan was reduced from 9% to 8% through the maturity date of October 31, 2024 or earlier, upon the
occurrence of a change in control (“Loan Maturity Date”). |
|
|
|
|
● |
The Company has the option
to request an extension of the Loan Maturity Date in writing no less than sixty days prior to the Loan Maturity Date. If BroadOak
agreed to the extension, the Loan Maturity Date would automatically be extended. |
On
March 29, 2024, the Company entered into a Third Amendment to the Loan and Security Agreement with BroadOak (the “Third Amendment”),
extending the loan maturity date to June 30, 2025. The primary changes to the Second Amendment were as follows:
|
● |
The maturity date was extended
to June 30, 2025. |
|
|
|
|
● |
Beginning April 1, 2024,
the Company will make $500,000 monthly payments with the remaining loan balance due on the new maturity date. |
The
Term Loan contains affirmative and negative restrictive covenants, including restrictions on certain mergers, acquisitions, investments
and encumbrances which could adversely affect our ability to conduct our business. The Term Loan also contains customary events of default.
The balance of the loan at June 30, 2024 was $7.4 million.
For
the six months ended June 30, 2024, we had operating income from continuing operations of $3.1 million. As of the six months ended June
30, 2024, we had cash and cash equivalents of $2.0 million, total current assets of $10.2 million and current liabilities of $19.0 million.
As of August 2, 2024, we had approximately $1.8 million of cash and cash equivalents.
During
the six months ended June 30, 2024, net cash provided by operating activities was $1.3 million. The main component of cash provided by
operating activities was our net income of $2.5 million, partially offset by an increase in accounts receivable of $1.2 million. During
the six months ended June 30, 2023, net cash provided by operating activities was $1.5 million. The
main component of cash provided by operating activities was our net income of $0.5 million, which included non-cash expenses of $1.3
million.
For
both periods net cash used in investing activities was primarily related to the purchase of lab equipment.
For
the six months ended June 30, 2024, cash used in financing activities was $2.6 million, which were payments made on the BroadOak Term
Loan. For the six months ended June 30, 2023, cash used in financing activities was $1.0 million, which were payments made on the Comerica
Revolving Line of Credit.
We
intend to meet our ongoing capital needs by using our available cash generated from operations as well as through targeted margin improvement;
collection of accounts receivable; containment of costs; and the potential use of other financing options and other strategic alternatives.
The
Company continues to explore various strategic alternatives, dilutive and non-dilutive sources of funding, including equity and debt
financings, strategic alliances, business development and other sources in order to provide additional liquidity. With the Company’s
delisting of its common stock from Nasdaq in February 2021, our ability to raise additional capital on terms acceptable to the Company
has been adversely impacted. There can be no assurance that the Company will be successful in obtaining such funding on terms acceptable
to the Company.
Further,
along with many laboratories, we may be affected by the Proposed LCD DL39365, which is currently under consideration by our local
Medicare Administrative Contractor, Novitas. If finalized, this Proposed LCD, which governs “Genetic Testing for
Oncology,” could impact the existing Medicare coverage for one of our molecular tests, PancraGEN®. On June 5,
2023 we announced that Novitas issued the final LCD of Genetic Testing for Oncology (L39365) which, if finalized, would have
established non-coverage for the Company’s widely used PancraGEN® test effective July 17, 2023. On July 6,
2023, Novitas announced that it would not be implementing the final Genetic Testing for Oncology LCD (L39365) as scheduled on July
17, 2023. Novitas then issued a new virtually identical proposed LCD affecting the same companies and tests and reaching the same
conclusions as noted in the previously rescinded LCD on July 27, 2023. In response, the Company participated in a public meeting
presentation and submitted detailed written comments supporting the use of PancraGEN®. The timing and content of any
final implemented LCD is uncertain at this time; the process could potentially take a year or longer from issuance of the updated
proposed LCD to reach a conclusion. On July 29, 2024 the Company announced that CMS granted Novitas an undefined
extension to the final decision for the LCD. As a result, we are able to continue offering PancraGEN® and the related
Point2® fluid chemistry tests for amylase, CEA, and glucose. In the event Novitas ultimately restricts coverage for
the PancraGEN® test, the Company’s liquidity could be negatively impacted.
Inflation
We
do not believe that inflation had a significant impact on our results of operations for the periods presented. However, inflation and
supply chain disruptions, whether caused by restrictions or slowdowns in shipping or logistics, increases in demand for certain goods
used in our operations, or otherwise, could impact our operations in the near term.
Critical
Accounting Estimates
See
Note 5, Summary of Significant Accounting Policies and Note 17, Recent Accounting Standards to the Interim Financial Statements
included elsewhere in this Quarterly Report on Form 10-Q for information regarding newly adopted and recent accounting pronouncements.
See also Note 1, Nature of Business and Significant Accounting Policies to our financial statements included in our Annual Report
on Form 10-K for the year ended December 31, 2023, as amended, for a discussion of our critical accounting policies. There have been
no material changes to such critical accounting policies. We believe our most critical accounting policies include accounting for contingent
consideration, revenue recognition, long-lived assets, research and development expenses and stock-based compensation expense.
Off-Balance
Sheet Arrangements
None.
Item
3. Quantitative and Qualitative Disclosures About Market Risk
As
a smaller reporting company, we are electing scaled disclosure reporting obligations and therefore are not required to provide the information
requested by this Item.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
principal executive officer and principal financial officer evaluated the effectiveness of our disclosure controls and procedures as
of June 30, 2024. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under 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 SEC’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 management’s evaluation of the Company’s disclosure controls and procedures, the principal executive officer and principal
financial officer of the Company identified a material weakness in the Company’s internal control over financial reporting in the
quarterly period ended March 31, 2024 related to the timing of revenue recognition based on the Company’s revenue recognition policy
and have concluded that the Company’s disclosure controls and procedures were not effective as of June 30, 2024 as a result of
such material weakness in the Company’s internal control over financial reporting.
The
Company has adopted a remediation plan, pursuant to which the Company plans to amend its internal controls to mitigate the material weakness,
which was identified by management, including by updating its procedures regarding the testing of revenue recognition, and reviewing
the procedures which ensure that revenue is recorded in the period in which it is earned. The Company believes implementation of these
processes and appropriate testing of their effectiveness will remediate the material weakness in the Company’s internal control
over financial reporting.
Changes
in Internal Controls over Financial Reporting
Other
than the material weakness and the adoption of the remediation plan discussed above, there has been no change in our internal control
over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the quarter covered
by this report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings
None.
Item
1A. Risk Factors
In
addition to the other information set forth in this report, you should carefully consider the factors discussed in Part I, Item 1A, “Risk
Factors” in our Annual Report on Form 10-K of the Company filed with the SEC on April 1, 2024, as amended, and as updated and supplemented
below and in subsequent filings. These risk factors could materially harm our business, operating results and financial condition. Additional
factors and uncertainties not currently known to us or that we currently consider immaterial also may materially adversely affect our
business, financial condition or future results.
If
the FDA implements its plans to regulate LDTs, such activities could have a material adverse effect on our clinical services and/or cause
us to incur substantial costs and delays associated with trying to obtain pre-market clearance or approval and comply with applicable
pre- and post-market requirements.
Clinical
laboratory tests like our clinical services tests are regulated under CLIA as well as by applicable state laws and may also be subject
to FDA regulation, depending on how the test is classified. For example, the FDA regulates in vitro diagnostic tests (also called in
vitro diagnostics or “IVDs”), specimen collection kits, analyte specific reagents (ASRs), and instruments used in conducting
diagnostic testing as medical devices. Most tests offered as LDTs have historically been subject to enforcement discretion by the FDA.
LDTs are defined by FDA as IVDs that are intended for clinical use and are designed, manufactured, and used within a single CLIA-certified,
high-complexity clinical laboratory.
On
April 29, 2024, however, the FDA published a final rule on LDTs, in which FDA outlines its plans to end enforcement discretion for many
LDTs in five stages over a four-year period. In Phase 1 (effective May 6, 2025), clinical laboratories running LDTs will be required
to comply with medical device (adverse event) reporting and correction/removal reporting requirements, as well as requirements for maintenance
of complaint files under the FDA’s quality systems regulation (QSR). In Phase 2 (effective May 6, 2026), clinical laboratories
will be required to comply with all other device requirements (e.g., registration/listing, labeling, investigational use), except for
the remaining QSR requirements and premarket review. In Phase 3 (effective May 6, 2027), clinical laboratories will be required to comply
with all remaining applicable QSR requirements. In Phase 4 (effective ~November 6, 2027), clinical laboratories will be required to comply
with premarket review requirements for high-risk tests (i.e., tests subject to the premarket approval (PMA) requirement). Finally, in
Phase 5 (effective May 6, 2028), clinical laboratories will be required to comply with premarket review requirements for moderate- and
low-risk tests (i.e., tests subject to the de novo or 510(k) requirement).
Under
the final rule, several types of tests will be eligible for some degree of continued enforcement discretion. For example, LDTs approved
by the NYSDOH will be exempt from premarket review requirements but will remain subject to the requirements of Phases 1 through 3. Similarly,
LDTs first marketed prior to May 6, 2024 that are not subsequently modified, or are modified only in certain limited ways, will be exempt
from the premarket review and most quality systems requirements, but will remain subject to the requirements of Phases 1 and 2. FDA notes,
however, that it retains discretion to pursue enforcement action for violations of the FDCA at any time and intends to do so when appropriate.
FDA further explains that it may update any of the enforcement discretion policies set forth in the final rule as circumstances warrant
or if the circumstances that inform those policies change, consistent with FDA’s good guidance practices. We are actively reviewing
the final rule to evaluate its applicability to our operations, and the extent to which we may be required to modify our operations to
comply with its requirements.
On
May 29, 2024, the American Clinical Laboratory Association filed a lawsuit challenging the FDA’s authority to regulate LDTs as
medical devices under the Federal Food, Drug, and Cosmetic Act. The outcome of this lawsuit is uncertain at this time.
If
we are required to submit applications to FDA for our currently marketed clinical tests and any tests that we may develop in the future,
we may be required to conduct additional studies, which may be time-consuming and costly and could result in our currently marketed tests
being withdrawn from the market. Continued compliance with the FDA’s regulations would increase the cost of conducting our clinical
services, and subject us to heightened regulation by the FDA and penalties for failure to comply with these requirements. Failure to
comply with applicable regulatory requirements can result in enforcement action by the FDA, such as warning letters, civil monetary penalties,
injunctions, criminal prosecution, recall or seizure, operating restrictions, partial suspension or total shutdown of operations, and
denial of or challenges to applications for clearance, authorization or approval, as well as significant adverse publicity. Any other
regulatory or legislative proposals that would increase general FDA oversight of clinical laboratories or LDTs could negatively impact
our business if additional requirements are imposed. We are monitoring developments and anticipate that our clinical services products
will be able to comply with requirements that are ultimately imposed by the FDA. In the meantime, we maintain our CLIA accreditation
and state licenses, which permit the use of LDTs for diagnostic purposes.
If
the FDA seeks to enforce the applicable medical device regulations against our clinical services tests, we could be subject to a wide
range of penalties and would likely be prohibited from continuing to offer the applicable tests in interstate commerce until we have
obtained FDA approval, authorization or clearance through the Premarket Approval (PMA), de novo or 510(k) process, respectively, as applicable.
Additionally, we could be subject to enforcement for noncompliance with the FDA’s regulations on marketing and promotional communications,
manufacturing, quality and safety standards, labeling, storage, registration and listing, recordkeeping, adverse event reporting, and
any other regulations applicable to IVDs. Any adverse enforcement action against us may have a material adverse effect on our clinical
services and results of operations.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item
3. Defaults Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
None.
Item
5. Other Information
None.
Item
6. Exhibits
Exhibit
No. |
|
Description |
|
|
|
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. |
|
|
|
31.1* |
|
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
31.2* |
|
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.1+ |
|
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.2+ |
|
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
101.INS |
|
Inline XBRL Instance Document
– the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL
document. |
101.SCH |
|
Inline XBRL Taxonomy Extension
Schema Document. |
101.CAL |
|
Inline XBRL Taxonomy Extension
Calculation Linkbase Document. |
101.DEF |
|
Inline XBRL Taxonomy Extension
Definition Linkbase Document. |
101.LAB |
|
Inline XBRL Taxonomy Extension
Label Linkbase Document. |
101.PRE |
|
Inline XBRL Taxonomy Extension
Presentation Linkbase Document. |
104 |
|
Cover Page Interactive
Data File (formatted as Inline XBRL and contained in Exhibits 101). |
* |
Filed Herewith. |
|
|
+ |
Exhibits 32.1 and 32.2
are being furnished herewith and shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act or
otherwise subject to the liability of that section, nor shall such exhibits be deemed to be incorporated by reference to any registration
statement or other document filed under the Securities Act or the Exchange Act, except as otherwise stated in any such filing. |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
Date: August
8, 2024 |
Interpace
Biosciences, Inc. |
|
(Registrant) |
|
|
|
/s/ Thomas
W. Burnell |
|
Thomas W. Burnell |
|
President and Chief Executive Officer |
|
(Principal Executive Officer) |
|
|
Date: August 8, 2024 |
/s/ Christopher
McCarthy |
|
Christopher McCarthy |
|
Chief Financial Officer |
|
(Principal
Financial Officer) |
Exhibit
31.1
CERTIFICATION
PURSUANT TO SECTION 302
OF
THE SARBANES-OXLEY ACT OF 2002
I,
Thomas W. Burnell, certify that:
|
1. |
I have reviewed this Quarterly
Report on Form 10-Q for the quarter ended June 30, 2024 of Interpace Biosciences, Inc. (the “registrant”); |
|
|
|
|
2. |
Based on my knowledge,
this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements
made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this
report; |
|
|
|
|
3. |
Based on my knowledge,
the financial statements, and other financial information included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
|
|
|
|
4. |
The registrant’s
other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f)
and 15d-15(f)) for the registrant and have: |
|
a. |
Designed such disclosure
controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities,
particularly during the period in which this report is being prepared; |
|
|
|
|
b. |
Designed such internal
control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision,
to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for
external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c. |
Evaluated the effectiveness
of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness
of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
|
|
|
|
d. |
Disclosed in this report
any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is
reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
|
5. |
The registrant’s
other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting,
to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the
equivalent functions): |
|
a. |
All significant deficiencies
and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely
affect the registrant’s ability to record, process, summarize and report financial information; and |
|
|
|
|
b. |
Any fraud, whether or not
material, that involves management or other employees who have a significant role in the registrant’s internal control over
financial reporting. |
Date: August 8, 2024 |
/s/
Thomas W. Burnell |
|
Chief Executive Officer |
|
(Principal Executive Officer) |
Exhibit
31.2
CERTIFICATION
PURSUANT TO SECTION 302
OF
THE SARBANES-OXLEY ACT OF 2002
I,
Christopher McCarthy, certify that:
|
1. |
I have reviewed this Quarterly
Report on Form 10-Q for the quarter ended June 30, 2024 of Interpace Biosciences, Inc. (the “registrant”); |
|
|
|
|
2. |
Based on my knowledge,
this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements
made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this
report; |
|
|
|
|
3. |
Based on my knowledge,
the financial statements, and other financial information included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
|
|
|
|
4. |
The registrant’s
other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f)
and 15d-15(f)) for the registrant and have: |
|
a. |
Designed such disclosure
controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities,
particularly during the period in which this report is being prepared; |
|
|
|
|
b. |
Designed such internal
control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision,
to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for
external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c. |
Evaluated the effectiveness
of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness
of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
|
|
|
|
d. |
Disclosed in this report
any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is
reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
|
5. |
The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions): |
|
a. |
All significant deficiencies
and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely
affect the registrant’s ability to record, process, summarize and report financial information; and |
|
|
|
|
b. |
Any fraud, whether or not
material, that involves management or other employees who have a significant role in the registrant’s internal control over
financial reporting. |
Date: August 8, 2024 |
/s/
Christopher McCarthy |
|
Chief Financial Officer |
|
(Principal Financial Officer) |
Exhibit
32.1
CERTIFICATION
PURSUANT TO
18
U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report of Interpace Biosciences, Inc. (the “Company”) on Form 10-Q for the period ended June
30, 2024 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Thomas W. Burnell, as
Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002, to the best of my knowledge, that:
|
(1) |
The Report fully complies
with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
|
|
|
|
(2) |
The information contained
in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: August 8, 2024 |
/s/
Thomas W. Burnell |
|
Chief Executive Officer |
|
(Principal Executive Officer) |
Exhibit
32.2
CERTIFICATION
PURSUANT TO
18
U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report of Interpace Biosciences, Inc. (the “Company”) on Form 10-Q for the period ended June
30, 2024 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Christopher McCarthy
as Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002, to the best of my knowledge, that:
|
(1) |
The Report fully complies
with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
|
|
|
|
(2) |
The information contained
in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: August 8, 2024 |
/s/
Christopher McCarthy |
|
Chief Financial Officer |
|
(Principal Financial Officer) |
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v3.24.2.u1
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash and cash equivalents |
$ 2,019
|
$ 3,498
|
Accounts receivable, net of allowance for credit loss of $26 and $0, respectively |
6,206
|
4,983
|
Other current assets |
1,941
|
1,841
|
Total current assets |
10,166
|
10,322
|
Property and equipment, net |
1,126
|
790
|
Operating lease right of use assets |
1,635
|
1,864
|
Other long-term assets |
45
|
45
|
Total assets |
12,972
|
13,021
|
Current liabilities: |
|
|
Accounts payable |
1,761
|
1,544
|
Accrued salary and bonus |
1,243
|
1,969
|
Other accrued expenses |
8,582
|
8,201
|
Note payable at fair value, current |
6,784
|
5,100
|
Current liabilities of discontinued operations |
660
|
660
|
Total current liabilities |
19,030
|
17,474
|
Operating lease liabilities, net of current portion |
1,286
|
1,472
|
Note payable at fair value |
|
4,243
|
Other long-term liabilities |
5,146
|
4,968
|
Total liabilities |
25,462
|
28,157
|
Commitments and contingencies (Note 8) |
|
|
Redeemable preferred stock, $.01 par value; 5,000,000 shares authorized, 47,000 shares Series B issued and outstanding |
46,536
|
46,536
|
Stockholders’ deficit: |
|
|
Common stock, $.01 par value; 100,000,000 shares authorized; 4,487,157 and 4,447,489 shares issued, respectively; 4,376,398 and 4,351,445 shares outstanding, respectively |
406
|
405
|
Additional paid-in capital |
188,277
|
188,146
|
Accumulated deficit |
(245,685)
|
(248,215)
|
Treasury stock, at cost (110,759 and 96,044 shares, respectively) |
(2,024)
|
(2,008)
|
Total stockholders’ deficit |
(59,026)
|
(61,672)
|
Total liabilities and stockholders’ deficit |
(33,564)
|
(33,515)
|
Total liabilities, preferred stock and stockholders’ deficit |
$ 12,972
|
$ 13,021
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v3.24.2.u1
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Allowance for credit loss |
$ 26,000
|
$ 0
|
Temporary equity, par value |
$ 0.01
|
$ 0.01
|
Temporary equity, shares authorized |
5,000,000
|
5,000,000
|
Common stock, par value |
$ 0.01
|
$ 0.01
|
Common stock, shares authorized |
100,000,000
|
100,000,000
|
Common stock, shares issued |
4,487,157
|
4,447,489
|
Common stock, shares outstanding |
4,376,398
|
4,351,445
|
Treasury stock, shares |
110,759
|
96,044
|
Series B Preferred Stock [Member] |
|
|
Temporary equity, shares issued |
47,000
|
47,000
|
Temporary equity, shares outstanding |
47,000
|
47,000
|
X |
- DefinitionAmount of allowance for credit loss on accounts receivable, classified as current.
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v3.24.2.u1
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
Revenue, net |
$ 12,042
|
$ 11,026
|
$ 22,314
|
$ 20,853
|
Cost of revenue |
4,611
|
4,191
|
8,812
|
8,039
|
Gross profit |
7,431
|
6,835
|
13,502
|
12,814
|
Operating expenses: |
|
|
|
|
Sales and marketing |
2,887
|
2,605
|
5,707
|
4,947
|
Research and development |
146
|
186
|
283
|
335
|
General and administrative |
2,141
|
2,894
|
4,381
|
5,389
|
Acquisition related amortization expense |
|
318
|
|
635
|
Total operating expenses |
5,174
|
6,003
|
10,371
|
11,306
|
Operating income from continuing operations |
2,257
|
832
|
3,131
|
1,508
|
Interest accretion expense |
(12)
|
(31)
|
(30)
|
(66)
|
Note payable interest |
(176)
|
(228)
|
(373)
|
(453)
|
Other income (expense), net |
71
|
(174)
|
(12)
|
(156)
|
Income from continuing operations before tax |
2,140
|
399
|
2,716
|
833
|
Provision for income taxes |
4
|
4
|
8
|
8
|
Income from continuing operations |
2,136
|
395
|
2,708
|
825
|
Loss from discontinued operations, net of tax |
(74)
|
(220)
|
(178)
|
(299)
|
Net income |
$ 2,062
|
$ 175
|
$ 2,530
|
$ 526
|
Basic income (loss) per share of common stock: |
|
|
|
|
From continuing operations |
$ 0.49
|
$ 0.09
|
$ 0.62
|
$ 0.19
|
From discontinued operations |
(0.02)
|
(0.05)
|
(0.04)
|
(0.07)
|
Net income per basic share of common stock |
0.47
|
0.04
|
0.58
|
0.12
|
Diluted income (loss) per share of common stock: |
|
|
|
|
From continuing operations |
0.49
|
0.09
|
0.62
|
0.19
|
From discontinued operations |
(0.02)
|
(0.05)
|
(0.04)
|
(0.07)
|
Net income per diluted share of common stock |
$ 0.47
|
$ 0.04
|
$ 0.58
|
$ 0.12
|
Weighted average number of common shares and common share equivalents outstanding: |
|
|
|
|
Basic |
4,376
|
4,311
|
4,373
|
4,309
|
Diluted |
4,401
|
4,316
|
4,393
|
4,313
|
X |
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v3.24.2.u1
Condensed Consolidated Statements of Stockholders' Deficit (Unaudited) - USD ($) $ in Thousands |
Common Stock [Member] |
Treasury Stock, Common [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Balance at Dec. 31, 2022 |
$ 405
|
$ (1,976)
|
$ 187,516
|
$ (249,017)
|
$ (63,072)
|
Balance, shares at Dec. 31, 2022 |
4,367,830
|
71,120
|
|
|
|
Issuance of common stock |
|
|
|
|
|
Issuance of common stock, shares |
22,996
|
|
|
|
|
Treasury stock purchased |
|
$ (9)
|
|
|
(9)
|
Treasury stock purchased, shares |
|
8,292
|
|
|
|
Stock-based compensation expense |
|
|
192
|
|
192
|
Net income |
|
|
|
351
|
351
|
Balance at Mar. 31, 2023 |
$ 405
|
$ (1,985)
|
187,708
|
(248,666)
|
(62,538)
|
Balance, shares at Mar. 31, 2023 |
4,390,826
|
79,412
|
|
|
|
Balance at Dec. 31, 2022 |
$ 405
|
$ (1,976)
|
187,516
|
(249,017)
|
(63,072)
|
Balance, shares at Dec. 31, 2022 |
4,367,830
|
71,120
|
|
|
|
Net income |
|
|
|
|
526
|
Balance at Jun. 30, 2023 |
$ 405
|
$ (1,985)
|
187,865
|
(248,491)
|
(62,206)
|
Balance, shares at Jun. 30, 2023 |
4,390,826
|
79,412
|
|
|
|
Balance at Mar. 31, 2023 |
$ 405
|
$ (1,985)
|
187,708
|
(248,666)
|
(62,538)
|
Balance, shares at Mar. 31, 2023 |
4,390,826
|
79,412
|
|
|
|
Stock-based compensation expense |
|
|
157
|
|
157
|
Net income |
|
|
|
175
|
175
|
Balance at Jun. 30, 2023 |
$ 405
|
$ (1,985)
|
187,865
|
(248,491)
|
(62,206)
|
Balance, shares at Jun. 30, 2023 |
4,390,826
|
79,412
|
|
|
|
Balance at Dec. 31, 2023 |
$ 405
|
$ (2,008)
|
188,146
|
(248,215)
|
(61,672)
|
Balance, shares at Dec. 31, 2023 |
4,447,489
|
96,044
|
|
|
|
Issuance of common stock |
$ 1
|
|
(1)
|
|
|
Issuance of common stock, shares |
39,668
|
|
|
|
|
Treasury stock purchased |
|
$ (16)
|
|
|
(16)
|
Treasury stock purchased, shares |
|
14,715
|
|
|
|
Stock-based compensation expense |
|
|
79
|
|
79
|
Net income |
|
|
|
468
|
468
|
Balance at Mar. 31, 2024 |
$ 406
|
$ (2,024)
|
188,224
|
(247,747)
|
(61,141)
|
Balance, shares at Mar. 31, 2024 |
4,487,157
|
110,759
|
|
|
|
Balance at Dec. 31, 2023 |
$ 405
|
$ (2,008)
|
188,146
|
(248,215)
|
(61,672)
|
Balance, shares at Dec. 31, 2023 |
4,447,489
|
96,044
|
|
|
|
Net income |
|
|
|
|
2,530
|
Balance at Jun. 30, 2024 |
$ 406
|
$ (2,024)
|
188,277
|
(245,685)
|
(59,026)
|
Balance, shares at Jun. 30, 2024 |
4,487,157
|
110,759
|
|
|
|
Balance at Mar. 31, 2024 |
$ 406
|
$ (2,024)
|
188,224
|
(247,747)
|
(61,141)
|
Balance, shares at Mar. 31, 2024 |
4,487,157
|
110,759
|
|
|
|
Stock-based compensation expense |
|
|
53
|
|
53
|
Net income |
|
|
|
2,062
|
2,062
|
Balance at Jun. 30, 2024 |
$ 406
|
$ (2,024)
|
$ 188,277
|
$ (245,685)
|
$ (59,026)
|
Balance, shares at Jun. 30, 2024 |
4,487,157
|
110,759
|
|
|
|
X |
- DefinitionAmount of increase to additional paid-in capital (APIC) for recognition of cost for award under share-based payment arrangement.
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v3.24.2.u1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Cash Flows From Operating Activities |
|
|
Net income |
$ 2,530
|
$ 526
|
Adjustments to reconcile net income to net cash provided by operating activities: |
|
|
Depreciation and amortization |
119
|
714
|
Interest accretion expense |
30
|
66
|
Amortization of deferred financing fees |
|
28
|
Stock-based compensation |
132
|
349
|
Bad debt expense reversal |
(100)
|
|
Credit loss expense |
26
|
|
Change in fair value of note payable |
41
|
142
|
Amortization on operating lease right of use asset |
229
|
349
|
Other changes in operating assets and liabilities: |
|
|
Accounts receivable |
(1,249)
|
(497)
|
Other current assets |
|
(101)
|
Accounts payable |
(13)
|
610
|
Accrued salaries and bonus |
(726)
|
(329)
|
Other accrued expenses |
337
|
(138)
|
Operating lease liabilities |
(188)
|
(337)
|
Other long-term liabilities |
178
|
162
|
Net cash provided by operating activities |
1,346
|
1,544
|
Cash Flows From Investing Activity |
|
|
Working capital adjustment on sale of Interpace Pharma Solutions |
|
(117)
|
Purchase of property and equipment |
(225)
|
(176)
|
Net cash used in investing activities |
(225)
|
(293)
|
Cash Flows From Financing Activities |
|
|
Payments made on note payable |
(2,600)
|
|
Payments on line of credit |
|
(1,000)
|
Net cash used in financing activities |
(2,600)
|
(1,000)
|
Net (decrease) increase in cash, cash equivalents and restricted cash |
(1,479)
|
251
|
Cash, cash equivalents and restricted cash from continuing operations– beginning |
3,498
|
4,828
|
Cash, cash equivalents and restricted cash from discontinued operations– beginning |
|
|
Cash, cash equivalents and restricted cash – beginning |
3,498
|
4,828
|
Cash, cash equivalents and restricted cash from continuing operations– ending |
2,019
|
5,079
|
Cash, cash equivalents and restricted cash from discontinued operations– ending |
|
|
Cash, cash equivalents and restricted cash – ending |
$ 2,019
|
$ 5,079
|
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v3.24.2.u1
OVERVIEW
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
OVERVIEW |
1. OVERVIEW
Nature
of Business
Interpace
Biosciences, Inc. (“Interpace” or the “Company”) is a company that provides molecular diagnostics, bioinformatics
and pathology services for evaluation of risk of cancer by leveraging the latest technology in personalized medicine for improved patient
diagnosis and management. The Company develops and commercializes genomic tests and related first line assays principally focused on
early detection of patients with indeterminate biopsies and at high risk of cancer using the latest technology.
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v3.24.2.u1
BASIS OF PRESENTATION
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
BASIS OF PRESENTATION |
2. BASIS OF PRESENTATION
The
accompanying unaudited interim condensed consolidated financial statements and related notes (the “Interim Financial Statements”)
should be read in conjunction with the consolidated financial statements of the Company and its wholly-owned subsidiaries (Interpace
Diagnostics Lab Inc., Interpace Diagnostics Corporation, and Interpace Diagnostics, LLC), and related notes as included in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities & Exchange Commission (“SEC”)
on April 1, 2024 and as amended on April 26, 2024.
The
Interim Financial Statements of the Company have been prepared in accordance with generally accepted accounting principles in the United
States (“GAAP”) for interim financial reporting and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly,
they do not include all of the information and footnotes required by GAAP for complete financial statements. The Interim Financial Statements
include all normal recurring adjustments that, in the judgment of management, are necessary for a fair presentation of such interim financial
statements. Discontinued operations include the Company’s wholly owned subsidiaries: Group DCA, LLC, InServe Support Solutions;
and TVG, Inc., its Commercial Services business unit, which was sold on December 22, 2015 and its Interpace Pharma Solutions business
(“Pharma Solutions”) which was sold on August 31, 2022. All significant intercompany balances and transactions have been
eliminated in consolidation. Operating results for the three-month period ended June 30, 2024 are not necessarily indicative of the results
that may be expected for the fiscal year ending December 31, 2024.
|
X |
- DefinitionThe entire disclosure for the basis of accounting, or basis of presentation, used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS).
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v3.24.2.u1
LIQUIDITY
|
6 Months Ended |
Jun. 30, 2024 |
Liquidity |
|
LIQUIDITY |
3. LIQUIDITY
In
October 2021, the Company entered into a $7.5 million revolving credit facility with Comerica Bank (“Comerica”) (the “Comerica
Loan Agreement”). In February 2024, the Company terminated the Comerica Loan Agreement. The Company did not owe anything outstanding
on the line of credit at the time of termination and does not owe anything further to Comerica. See Note 16, Revolving Line of Credit.
Also in October 2021, the Company entered into an $8.0 million term loan with BroadOak Fund V, L.P. (“BroadOak”) (the “Term
Loan”), the proceeds of which were used to repay in full at their maturity the existing secured promissory note with Ampersand
Capital Partners (“Ampersand”) (the “Ampersand Note”) and 1315 Capital II, L.P (“1315 Capital”) (the
“1315 Capital Note”). In May 2022, the Company entered into a Subordinated Convertible Promissory Note agreement with BroadOak
for an additional $2.0 million (the “Convertible Note”), which was converted into a subordinated term loan and was added
to the outstanding Term Loan balance. The Term Loan has been subsequently amended. See Note 13, Notes Payable, for more details.
Along
with many laboratories, the Company may be affected by the Proposed Local Coverage Determination (“LCD”) DL39365, which
is currently under consideration by Novitas, the Company’s medical administrator contractor. If finalized, this Proposed LCD,
which governs “Genetic Testing for Oncology,” could impact the existing Medicare coverage for one of our molecular
tests, PancraGEN®. On June 5, 2023, the Company announced that Novitas issued the final LCD of Genetic Testing for
Oncology (L39365) which if finalized, would have established non-coverage for the Company’s widely used
PancraGEN® test effective July 17, 2023. On July 6, 2023, Novitas announced that it would not be implementing the
final Genetic Testing for Oncology LCD (L39365) as scheduled on July 17, 2023. Novitas then issued a new virtually identical
proposed LCD affecting the same companies and tests and reaching the same conclusions as noted in the previously rescinded LCD on
July 27, 2023. In response, the Company participated in a public meeting presentation and submitted detailed written comments
supporting the use of PancraGEN®. The timing and content of any final implemented LCD is uncertain at this time; the
process could potentially take a year or longer from issuance of the updated proposed LCD to reach a conclusion. On July
29, 2024 the Company announced that CMS granted Novitas an undefined extension to the final decision for the LCD. As a
result, the Company is able to continue offering PancraGEN® and the related Point2® fluid chemistry
tests for amylase, CEA, and glucose. In the event Novitas ultimately restricts coverage for the PancraGEN® test, the
Company’s liquidity could be negatively impacted.
For
the six months ended June 30, 2024, the Company had operating income from continuing operations of $3.1 million. As of June 30, 2024,
the Company had cash and cash equivalents of $2.0 million, total current assets of $10.2 million and current liabilities of $19.0 million.
As of August 2, 2024, the Company had approximately $1.8 million of cash and cash equivalents.
The
Company intends to meet its ongoing capital needs by using its available cash, as well as through targeted margin improvement; collection
of accounts receivable; containment of costs; and the potential use of other financing options and other strategic alternatives.
The
Company continues to explore various strategic alternatives, dilutive and non-dilutive sources of funding, including equity and debt
financings, strategic alliances, business development and other sources in order to provide additional liquidity. With the delisting
of its common stock from Nasdaq in February 2021, the Company’s ability to raise additional capital on terms acceptable to it has
been adversely impacted. There can be no assurance that the Company will be successful in obtaining such funding on terms acceptable
to it.
With
the improvement in operating cash flows associated with the disposition of the Pharma Solutions business, and the Company’s improved
operating performance, as of the date of this filing, the Company anticipates that current cash and cash equivalents and forecasted cash
receipts will be sufficient to meet its anticipated cash requirements through the next twelve months from the date of the filing of this
report.
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v3.24.2.u1
DISCONTINUED OPERATIONS
|
6 Months Ended |
Jun. 30, 2024 |
Discontinued Operations and Disposal Groups [Abstract] |
|
DISCONTINUED OPERATIONS |
4. DISCONTINUED OPERATIONS
Liabilities
classified as discontinued operations as of both June 30, 2024 and December 31, 2023 consists of accrued expenses which are liabilities
related to the former Commercial Services business unit.
The
table below presents the significant components of its former Pharma Solutions business unit’s results included within loss from
discontinued operations, net of tax in the condensed consolidated statements of operations for the three- and six months ended June 30,
2024 and 2023.
SCHEDULE
OF COMPONENTS OF ASSETS AND LIABILITIES AND REVENUE CLASSIFIED AS DISCONTINUED
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For The Three Months Ended | | |
For The Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Revenue, net | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Loss from discontinued operations | |
| - | | |
| (137 | ) | |
| - | | |
| (137 | ) |
Income tax expense | |
| 74 | | |
| 83 | | |
| 178 | | |
| 162 | |
Loss from discontinued operations, net of tax | |
$ | (74 | ) | |
$ | (220 | ) | |
$ | (178 | ) | |
$ | (299 | ) |
Cash
used from discontinued operations, operating activities, was $20,000, and investing activities was $0.1 million for the six months ended
June 30, 2023. There was no cash used from discontinued operations for the six months ended June 30, 2024.There was no depreciation and
amortization expense for the three or six months ended June 30, 2024 and June 30, 2023, respectively, in discontinued operations.
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- DefinitionThe entire disclosure related to a disposal group. Includes, but is not limited to, a discontinued operation, disposal classified as held-for-sale or disposed of by means other than sale or disposal of an individually significant component.
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v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
5. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Accounting
Estimates
The
preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions
that affect the amounts of assets and liabilities reported and disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the reporting period. Management’s estimates are based on historical
experience, facts and circumstances available at the time, and various other assumptions that are believed to be reasonable under the
circumstances. Significant estimates include accounting for valuation allowances related to deferred income taxes, contingent consideration,
allowances for credit losses, revenue recognition, unrecognized tax benefits, and asset impairments involving intangible assets. The
Company periodically reviews these matters and reflects changes in estimates in earnings as appropriate. Actual results could materially
differ from those estimates.
Revenue
Recognition
We
derive our revenues from the performance of proprietary assays or tests. The Company’s performance obligation is fulfilled upon
the completion, review and release of test results to the customer. We subsequently bill third-party payers or direct-bill payers for
the tests performed. Under Accounting Standards Codification 606, revenue is recognized based on the estimated transaction price or net
realizable value, which is determined based on historical collection rates by each payer category for each proprietary test offered by
the Company. To the extent the transaction price includes variable consideration, for all third party and direct-bill payers and proprietary
tests, we estimate the amount of variable consideration that should be included in the transaction price using the expected value method
based on historical experience.
We
regularly review the ultimate amounts received from the third-party and direct-bill payers and related estimated reimbursement rates
and adjust the NRV’s and related contractual allowances accordingly. If actual collections and related NRV’s vary significantly
from our estimates, we will adjust the estimates of contractual allowances, which affects net revenue in the period such variances become
known.
Financing
and Payment
For
non-Medicare claims, our payment terms vary by payer category. Payment terms for direct-payers in our clinical services are typically
thirty days and in our pharma services, were up to sixty days. Commercial third-party-payers are required to respond to a claim within
a time period established by their respective state regulations, generally between thirty to sixty days. However, payment for commercial
third-party claims may be subject to a denial and appeal process, which could take up to two years in some instances where multiple appeals
are submitted. The Company generally appeals all denials from commercial third-party payers. We bill Medicare directly for tests performed
for Medicare patients and must accept Medicare’s fee schedule for the covered tests as payment in full.
Costs
to Obtain or Fulfill a Customer Contract
Sales
commissions are expensed in the period in which they have been earned. These costs are recorded in sales and marketing expense in the
condensed consolidated statements of operations.
Accounts
Receivable
The
Company’s accounts receivable represent unconditional rights to consideration and are generated using its clinical services. 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.
The allowance for credit losses balance was $26,000 and $0 at June 30, 2024 and December 31, 2023, respectively.
Leases
The
Company determines if an arrangement contains a lease in whole or in part at the inception of the contract. Right-of-use (“ROU”)
assets represent the Company’s right to use an underlying asset for the lease term while lease liabilities represent our obligation
to make lease payments arising from the lease. All leases with terms greater than twelve months result in the recognition of a ROU asset
and a liability at the lease commencement date based on the present value of the lease payments over the lease term. Unless a lease provides
all of the information required to determine the implicit interest rate, we use our incremental borrowing rate based on the information
available at the commencement date in determining the present value of the lease payments. We use the implicit interest rate in the lease
when readily determinable.
Our
lease terms include all non-cancelable periods and may include options to extend (or to not terminate) the lease when it is reasonably
certain that we will exercise that option. Leases with terms of twelve months or less at the commencement date are expensed on a straight-line
basis over the lease term and do not result in the recognition of an asset or liability. See Note 7, Leases.
Other
Current Assets
Other
current assets consisted of the following as of June 30, 2024 and December 31, 2023:
SCHEDULE
OF OTHER CURRENT ASSETS
| |
June 30, 2024 | | |
December 31, 2023 | |
Lab supplies | |
$ | 1,231 | | |
$ | 1,227 | |
Prepaid expenses | |
| 667 | | |
| 590 | |
Other | |
| 43 | | |
| 24 | |
Total other current assets | |
$ | 1,941 | | |
$ | 1,841 | |
Long-Lived
Assets, including Finite-Lived Intangible Assets
Finite-lived
intangible assets are stated at cost less accumulated amortization. Amortization of finite-lived acquired intangible assets is recognized
on a straight-line basis, using the estimated useful lives of the assets of approximately two years to ten years in acquisition-related
amortization expense in the condensed consolidated statements of operations.
The
Company reviews the recoverability of long-lived assets and finite-lived intangible assets whenever events or changes in circumstances
indicate that the carrying value of such assets may not be recoverable. If the sum of the expected future undiscounted cash flows is
less than the carrying amount of the asset, an impairment loss is recognized by reducing the recorded value of the asset to its fair
value measured by future discounted cash flows. This analysis requires estimates of the amount and timing of projected cash flows and,
where applicable, judgments associated with, among other factors, the appropriate discount rate. Such estimates are critical in determining
whether any impairment charge should be recorded and the amount of such charge if an impairment loss is deemed to be necessary.
Basic
and Diluted Net Income (Loss) per Share
A
reconciliation of the number of shares of common stock, par value $0.01 per share, used in the calculation of basic and diluted income
(loss) per share for the three- and six-month periods ended June 30, 2024 and 2023 is as follows:
SCHEDULE
OF BASIC AND DILUTED NET LOSS PER SHARE
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Basic weighted average number of common shares | |
| 4,376 | | |
| 4,311 | | |
| 4,373 | | |
| 4,309 | |
Potential dilutive effect of stock-based awards | |
| 25 | | |
| 5 | | |
| 20 | | |
| 4 | |
Diluted weighted average number of common shares | |
| 4,401 | | |
| 4,316 | | |
| 4,393 | | |
| 4,313 | |
The
Company’s Series B Redeemable Preferred Stock, on an as converted basis into common stock of 7,833,334 shares for the three- and
six-months ended June 30, 2024, and the following outstanding stock-based awards, were excluded from the computation of the effect of
dilutive securities on income (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
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Options | |
| 288 | | |
| 475 | | |
| 288 | | |
| 475 | |
Restricted stock units (RSUs) | |
| 182 | | |
| 215 | | |
| 187 | | |
| 217 | |
Anti-dilutive
securities | |
| 470 | | |
| 690 | | |
| 475 | | |
| 692 | |
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v3.24.2.u1
FAIR VALUE MEASUREMENTS
|
6 Months Ended |
Jun. 30, 2024 |
Fair Value Disclosures [Abstract] |
|
FAIR VALUE MEASUREMENTS |
6. FAIR VALUE MEASUREMENTS
Cash
and cash equivalents, accounts receivable and accounts payable approximate fair value due to their relative short-term nature. The Company’s
financial liabilities reflected at fair value in the condensed consolidated financial statements include contingent consideration, warrant
liability and note payable. Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly
transaction between market participants at the measurement date. In determining fair value, the Company uses various methods including
market, income and cost approaches. Based on these approaches, the Company often utilizes certain assumptions that market participants
would use in pricing the asset or liability, including assumptions about risk and/or the risks inherent in the inputs to the valuation
technique. These inputs can be readily observable, market-corroborated, or generally unobservable inputs. The Company utilizes valuation
techniques that maximize the use of observable inputs and minimize the use of unobservable inputs. Based upon observable inputs used
in the valuation techniques, the Company is required to provide information according to the fair value hierarchy. The fair value hierarchy
ranks the quality and reliability of the information used to determine fair values into three broad levels as follows:
|
Level 1: |
Valuations for assets and
liabilities traded in active markets from readily available pricing sources for market transactions involving identical assets or
liabilities. |
|
|
|
|
Level 2: |
Valuations for assets and
liabilities traded in less active dealer or broker markets. Valuations are obtained from third-party pricing services for identical
or similar assets or liabilities. |
|
|
|
|
Level 3: |
Valuations incorporate
certain assumptions and projections in determining the fair value assigned to such assets or liabilities. |
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 June 30, 2024 | | |
Fair Value Measurements | |
| |
| | |
Fair | | |
As of June 30, 2024 | |
| |
Amount | | |
Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| | |
| |
Liabilities: | |
| | | |
| | | |
| | | |
| | | |
| | |
Contingent consideration: | |
| | | |
| | | |
| | | |
| | | |
| | |
Asuragen (1) | |
$ | 30 | | |
$ | 30 | | |
$ | - | | |
$ | - | | |
$ | 30 | |
Note payable: | |
| | | |
| | | |
| | | |
| | | |
| | |
BroadOak loan | |
| 7,400 | | |
| 6,784 | | |
| - | | |
| - | | |
| 6,784 | |
| |
$ | 7,430 | | |
$ | 6,814 | | |
$ | - | | |
$ | - | | |
$ | 6,814 | |
(1) |
See Note 9, Other Accrued Expenses |
| |
As of December 31, 2023 | | |
Fair Value Measurements | |
| |
Carrying | | |
Fair | | |
As of December 31, 2023 | |
| |
Amount | | |
Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Liabilities: | |
| | | |
| | | |
| | | |
| | | |
| | |
Contingent consideration: | |
| | | |
| | | |
| | | |
| | | |
| | |
Asuragen (1) | |
$ | 453 | | |
$ | 453 | | |
$ | - | | |
$ | - | | |
$ | 453 | |
Note payable: | |
| | | |
| | | |
| | | |
| | | |
| | |
BroadOak loan | |
| 10,000 | | |
| 9,343 | | |
| - | | |
| - | | |
| 9,343 | |
| |
$ | 10,453 | | |
$ | 9,796 | | |
$ | - | | |
$ | - | | |
$ | 9,796 | |
(1) |
See Note 9, Other Accrued Expenses |
In
connection with the acquisition of certain assets from Asuragen, Inc., the Company recorded contingent consideration related to contingent
payments and other revenue-based payments. The Company determined the fair value of the contingent consideration based on a probability-weighted
income approach derived from revenue estimates. The fair value measurement is based on significant inputs not observable in the market
and thus represents a Level 3 measurement.
In
connection with the Term 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.
A
roll forward of the carrying value of the Contingent Consideration Liability and BroadOak Loan to June 30, 2024 is as follows:
SCHEDULE
OF FAIR VALUE, ASSETS MEASURED ON RECURRING BASIS, UNOBSERVABLE INPUT RECONCILIATION
| |
| | |
| | |
| | |
| | |
Adjustment | | |
| |
| |
December 31,
2023 | | |
Payments | | |
Transferred
to Accrued
Expenses | | |
Accretion/
Interest Accrued | | |
to Fair Value/
Mark to
Market | | |
June 30,
2024 | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Asuragen | |
$ | 453 | | |
$ | - | | |
$ | (453 | ) | |
$ | 30 | | |
$ | - | | |
$ | 30 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
BroadOak loans | |
| 9,343 | | |
| (2,600 | ) | |
| - | | |
| - | | |
| 41 | | |
| 6,784 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
$ | 9,796 | | |
$ | (2,600 | ) | |
$ | (453 | ) | |
$ | 30 | | |
$ | 41 | | |
$ | 6,814 | |
Certain
of the Company’s non-financial assets, such as 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.
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- DefinitionThe entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.
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v3.24.2.u1
LEASES
|
6 Months Ended |
Jun. 30, 2024 |
Leases |
|
LEASES |
7. LEASES
The
table below presents the lease-related assets and liabilities recorded in the Condensed Consolidated Balance Sheet:
SCHEDULE
OF LEASE RELATED ASSETS AND LIABILITIES
| |
Classification on the Balance Sheet | |
June 30, 2024 | | |
December 31, 2023 | |
| |
| |
| | |
| |
Assets | |
| |
| | | |
| | |
Operating lease assets | |
Operating lease right of use assets | |
| 1,635 | | |
| 1,864 | |
Total lease assets | |
| |
$ | 1,635 | | |
$ | 1,864 | |
| |
| |
| | | |
| | |
Liabilities | |
| |
| | | |
| | |
Current | |
| |
| | | |
| | |
Operating lease liabilities | |
Other accrued expenses | |
| 319 | | |
| 377 | |
Total current lease liabilities | |
| |
$ | 319 | | |
$ | 377 | |
Noncurrent | |
| |
| | | |
| | |
Operating lease liabilities | |
Operating lease liabilities, net of current portion | |
| 1,286 | | |
| 1,472 | |
Total long-term lease liabilities | |
| |
| 1,286 | | |
| 1,472 | |
Total lease liabilities | |
| |
$ | 1,605 | | |
$ | 1,849 | |
The
weighted average remaining lease term for the Company’s operating leases was 3.9 years as of June 30, 2024 and the weighted average
discount rate for those leases was 11.9%. Total operating lease expense from continuing operations under these agreements for both the three months ended June
30, 2024 and 2023 was approximately $0.2 million and for the six months ended June 30, 2024 and 2023 was approximately $0.3 million
and $0.4 million, respectively. Total cash paid under these agreements for both the six months ended June 30, 2024 and 2023 was approximately
$0.4 million, respectively. The Company’s operating lease expenses are recorded within “Cost of revenue”
and “General and administrative expenses.”
The
table below reconciles the cash flows to the lease liabilities recorded on the Company’s Condensed Consolidated Balance Sheet as
of June 30, 2024:
SCHEDULE
OF MATURITIES OF OPERATING LEASE LIABILITIES
| |
Operating Leases | |
2024 - remaining six months | |
$ | 268 | |
2025 | |
| 450 | |
2026 | |
| 500 | |
2027 | |
| 550 | |
2028 | |
| 275 | |
Total minimum lease payments | |
| 2,043 | |
Less: amount of lease payments representing effects of discounting | |
| 438 | |
Present value of future minimum lease payments | |
| 1,605 | |
Less: current obligations under leases | |
| 319 | |
Long-term lease obligations | |
$ | 1,286 | |
|
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- DefinitionThe entire disclosure for operating leases of lessee. Includes, but is not limited to, description of operating lease and maturity analysis of operating lease liability.
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v3.24.2.u1
COMMITMENTS AND CONTINGENCIES
|
6 Months Ended |
Jun. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
COMMITMENTS AND CONTINGENCIES |
8. COMMITMENTS AND CONTINGENCIES
Litigation
From
time to time, the Company may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business.
When the Company is aware of a claim or potential claim, it assesses the likelihood of any loss or exposure. If it is probable that a
loss will result and the amount of the loss can be reasonably estimated, the Company will record a liability for the loss. In addition
to the estimated loss, the recorded liability includes probable and estimable legal costs associated with the claim or potential claim.
Litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may
harm the Company’s business. There is no pending litigation involving the Company at this time.
Due
to the nature of the businesses in which the Company is engaged, it is subject to certain risks. Such risks include, among others, risk
of liability for personal injury or death to persons using products or services that the Company promotes or commercializes. There can
be no assurance that substantial claims or liabilities will not arise in the future due to the nature of the Company’s business
activities. There is also the risk of employment related litigation and other litigation in the ordinary course of business.
The
Company could also be held liable for errors and omissions of its employees in connection with the services it performs that are outside
the scope of any indemnity or insurance policy. The Company could be materially adversely affected if it were required to pay damages
or incur defense costs in connection with a claim that is outside the scope of an indemnification agreement; if the indemnity, although
applicable, is not performed in accordance with its terms; or if the Company’s liability exceeds the amount of applicable insurance
or indemnity.
|
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.24.2.u1
OTHER ACCRUED EXPENSES
|
6 Months Ended |
Jun. 30, 2024 |
Payables and Accruals [Abstract] |
|
OTHER ACCRUED EXPENSES |
9. OTHER ACCRUED EXPENSES
Other
accrued expenses consisted of the following as of June 30, 2024 and December 31, 2023:
SCHEDULE OF OTHER ACCRUED EXPENSES
| |
June 30, 2024 | | |
December 31, 2023 | |
Accrued royalties | |
$ | 7,010 | | |
$ | 6,268 | |
Contingent consideration | |
| 30 | | |
| 453 | |
Operating lease liability | |
| 319 | | |
| 377 | |
Accrued sales and marketing - diagnostics | |
| 28 | | |
| 43 | |
Accrued lab costs - diagnostics | |
| 103 | | |
| 68 | |
Accrued professional fees | |
| 162 | | |
| 241 | |
Taxes payable | |
| 308 | | |
| 261 | |
All others | |
| 622 | | |
| 490 | |
Total other accrued expenses | |
$ | 8,582 | | |
$ | 8,201 | |
|
X |
- DefinitionThe entire disclosure for accounts payable, accrued expenses, and other liabilities that are classified as current at the end of the reporting period.
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v3.24.2.u1
STOCK-BASED COMPENSATION
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
STOCK-BASED COMPENSATION |
10. STOCK-BASED COMPENSATION
Historically,
stock options have been granted with an exercise price equal to the market value of the common stock on the date of grant, with expiration
10 years from the date they are granted, and generally vest over a one to three-year period for employees and members of the Board. Upon
exercise, new shares will be issued by the Company. The restricted shares and restricted stock units (“RSUs”) granted to
Board members and employees generally have a three-year graded vesting period and are subject to accelerated vesting and forfeiture under
certain circumstances.
There
were no stock option awards issued during the six months ended June 30, 2024 and June 30, 2023.
The
Company recognized approximately $0.1 million and $0.2 million of stock-based compensation expense within continuing operations during
the three-month periods ended June 30, 2024 and 2023, respectively and approximately $0.1 million and $0.3 million for the six-month
periods ended June 30, 2024 and 2023, respectively. The following table has a breakout of stock-based compensation expense from continuing
operations by line item.
SCHEDULE OF SHARE-BASED COMPENSATION ARRANGEMENTS BY SHARE-BASED PAYMENT AWARD
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Cost of revenue | |
$ | - | | |
$ | 12 | | |
$ | 4 | | |
$ | 26 | |
Sales and marketing | |
| 23 | | |
| 30 | | |
| 53 | | |
| 60 | |
General and administrative | |
| 30 | | |
| 115 | | |
| 75 | | |
| 263 | |
Total stock compensation expense | |
$ | 53 | | |
$ | 157 | | |
$ | 132 | | |
$ | 349 | |
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.24.2.u1
INCOME TAXES
|
6 Months Ended |
Jun. 30, 2024 |
Income Tax Disclosure [Abstract] |
|
INCOME TAXES |
11. INCOME TAXES
Generally,
accounting standards require companies to provide for income taxes each quarter based on their estimate of the effective tax rate for
the full year. The authoritative guidance for accounting for income taxes allows use of the discrete method when it provides a better
estimate of income tax expense. Due to the Company’s valuation allowance position, it is the Company’s position that the
discrete method provides a more accurate estimate of income tax expense and therefore income tax expense for the current quarter has
been presented using the discrete method. As the year progresses, the Company refines its estimate based on the facts and circumstances
by each tax jurisdiction. The following table summarizes income tax expense on income from continuing operations and the effective tax
rate for the three- and six-month periods ended June 30, 2024 and 2023:
SCHEDULE OF EFFECTIVE INCOME TAX RATE
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Provision for income tax | |
$ | 4 | | |
$ | 4 | | |
$ | 8 | | |
$ | 8 | |
Effective income tax rate | |
| 0.2 | % | |
| 1.0 | % | |
| 0.3 | % | |
| 1.0 | % |
Income
tax expense for both periods was primarily due to state franchise taxes.
Other
long-term liabilities consisted of uncertain tax positions as of June 30, 2024 and December 31, 2023.
|
X |
- DefinitionThe entire disclosure for income tax.
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- DefinitionThe entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.
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v3.24.2.u1
NOTES PAYABLE
|
6 Months Ended |
Jun. 30, 2024 |
Debt Disclosure [Abstract] |
|
NOTES PAYABLE |
13. NOTES PAYABLE
BroadOak
Loan
On
October 29, 2021, the Company and its subsidiaries entered into the Term Loan with BroadOak, providing for a term loan in the aggregate
principal amount of $8,000,000. Funding of the Term Loan took place on November 1, 2021. The Term Loan was scheduled to mature 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 was subordinate
to the Company’s $7,500,000 revolving credit facility with Comerica Bank. See Note 16, Revolving Line of Credit. The Term Loan
had an origination fee of 3% of the Term Loan amount, and a terminal payment equal to (i) 15% of the original principal amount of the
Term Loan if the change of control occurs on or prior to the first anniversary of the funding of the Term Loan, (ii) 20% of the original
principal amount of the Term Loan if the change of control occurs after the first anniversary but on or prior to the second anniversary
of the funding of the Term Loan and (iii) 30% of the original principal amount of the Term Loan if the change of control occurs after
the second anniversary of the funding of the Term Loan, or if the Term Loan is repaid on its maturity date.
The
Term Loan 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 Term Loan also contains customary events of default.
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 stockholders’ deficit. Accordingly, the Company elected the fair value option for the Note.
In
May 2022, the Company issued a convertible note to BroadOak, pursuant to which BroadOak funded a term loan in the aggregate principal
amount of $2.0 million, which was converted into a subordinated term loan and was added to the outstanding balance of the Term Loan.
On
October 24, 2023, the Company entered into a Second Amendment to Loan and Security Agreement (the “Second Amendment”) with
BroadOak. The primary changes to the original Term Loan were as follows:
|
● |
The Company made a one-time
payment in an aggregate amount equal to $2,500,000, on October 30, 2023 and applied the payment in full satisfaction of the $3,000,000
Terminal Payment (as defined in the Term Loan). See above regarding the Terminal Payment. |
|
● |
Effective November 1, 2023,
the interest rate under the Term Loan was reduced from 9% to 8% through the maturity date of October 31, 2024 or earlier, upon the
occurrence of a change in control (“Loan Maturity Date”). |
|
|
|
|
● |
The Company had the option
to request an extension of the Loan Maturity Date in writing no less than sixty days prior to the Loan Maturity Date. If BroadOak
agreed to the extension, the Loan Maturity Date would automatically be extended. |
On
March 29, 2024, the Company entered into a Third Amendment to Loan and Security Agreement with BroadOak (the “Third Amendment”).
The primary changes to the Second Amendment were as follows:
|
● |
The maturity date was extended
to June 30, 2025. |
|
● |
Beginning April 1, 2024,
the Company will make $500,000 monthly payments with the remaining loan balance due on the new maturity date. |
The
Third Amendment was treated as a debt modification which is accounted for prospectively. Since the Term Loan is carried at fair value
under the fair value option, the Second Amendment did not result in any extinguishment gain or loss upon amendment, and the impact of
the revised terms was incorporated into the Company’s first quarter 2024 fair value calculation.
The
balance of the loan outstanding at June 30, 2024 was $7.4 million.
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- DefinitionThe entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.
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v3.24.2.u1
SUPPLEMENTAL CASH FLOW INFORMATION
|
6 Months Ended |
Jun. 30, 2024 |
Supplemental Cash Flow Elements [Abstract] |
|
SUPPLEMENTAL CASH FLOW INFORMATION |
14. SUPPLEMENTAL CASH FLOW INFORMATION
Supplemental
Disclosures of Non-Cash Activities
(in
thousands)
SUPPLEMENTAL CASH FLOW INFORMATION
| |
2024 | | |
2023 | |
| |
Six Months Ended | |
| |
June 30, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Taxes accrued for repurchase of restricted shares | |
$ | 16 | | |
$ | 9 | |
Purchase of property and equipment included in accounts payable | |
| 230 | | |
| 29 | |
|
X |
- DefinitionThe entire disclosure for supplemental cash flow activities, including cash, noncash, and part noncash transactions, for the period. Noncash is defined as information about all investing and financing activities of an enterprise during a period that affect recognized assets or liabilities but that do not result in cash receipts or cash payments in the period. "Part noncash" refers to that portion of the transaction not resulting in cash receipts or cash payments in the period.
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v3.24.2.u1
MEZZANINE EQUITY
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
MEZZANINE EQUITY |
15. MEZZANINE EQUITY
Redeemable
Preferred Stock
On
January 10, 2020, the Company entered into a Securities Purchase and Exchange Agreement (the “Securities Purchase and Exchange
Agreement”) with 1315 Capital and Ampersand (collectively, the “Investors”) pursuant to which the Company agreed to
sell to the Investors an aggregate of $20.0 million in Series B Preferred Stock of the Company, at an issuance price per share of $1,000
(“New Investment Shares”). Pursuant to the Securities Purchase and Exchange Agreement, 1315 Capital agreed to purchase 19,000
shares of Series B Preferred Stock at an aggregate purchase price of $19.0 million and Ampersand agreed to purchase 1,000 shares of Series
B Preferred Stock at an aggregate purchase price of $1.0 million.
In
addition, the Company agreed to exchange $27.0 million of the Company’s existing Series A convertible preferred stock, par value
$0.01 per share, held by Ampersand (the “Series A Preferred Stock”), represented by 270 shares of Series A Preferred Stock
with a stated value of $100,000 per share, which represents all of the Company’s issued and outstanding Series A Preferred Stock,
for 27,000 newly issued shares of Series B Preferred Stock (such shares of Series B Preferred Stock, the “Exchange Shares”
and such transaction, the “Exchange”). Following the Exchange, no shares of Series A Preferred Stock remained designated,
authorized, issued or outstanding. The Series B Preferred Stock has a conversion price of $6.00.
Voting
On
any matter presented to the stockholders of the Company for their action or consideration at any meeting of stockholders of the Company
(or by written consent of stockholders in lieu of meeting), each holder of outstanding shares of Series B Preferred Stock will be entitled
to cast the number of votes equal to the number of whole shares of the Company’s common stock into which the shares of Series B
Preferred Stock held by such holder are convertible as of the record date for determining stockholders entitled to vote on such matter.
Except as provided by law or by the Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred
Stock (the “Certificate of Designation”), holders of Series B Preferred Stock will vote together with the holders of common
stock as a single class and on an as-converted to common stock basis.
Director
Designation Rights
The
Certificate of Designation also provides each Investor with the following director designation rights: for so long such Investor holds
at least sixty percent (60%) of the Series B Preferred Stock issued to it on the Issuance Date (as defined therein), such Investor will
be entitled to elect two directors to the Company’s Board of Directors (the “Board”), provided that one of the directors
qualifies as an “independent director” under Rule 5605(a)(2) of the listing rules of the Nasdaq Stock Market (or any successor
rule or similar rule promulgated by another exchange on which the Company’s securities are then listed or designated) (“Independent
Director”). However, if at any time such Investor holds less than sixty percent (60%), but at least forty percent (40%), of the
Series B Preferred Stock issued to them on the Issuance Date, such Investor would only be entitled to elect one director to the Board.
Any director elected pursuant to the terms of the Certificate of Designation may be removed without cause by, and only by, the affirmative
vote of the holders of Series B Preferred Stock. A vacancy in any directorship filled by the holders of Series B Preferred Stock may
be filled only by vote or written consent in lieu of a meeting of such holders of Series B Preferred Stock or by any remaining director
or directors elected by such holders of Series B Preferred Stock.
On
November 15, 2023, Edward Chan, a director designated by 1315 Capital to the Board, provided notice to the Company of his resignation
from the Board, effective immediately. Further, on December 7, 2023, Robert Gorman, a director designated by Ampersand to the Board,
provided notice to the Company of his resignation as a director and as Chairman of the Board, effective immediately.
As
of the date of this report, each of 1315 Capital and Ampersand has appointed one director to the Board, and each has not appointed a
second director to the Board.
Conversion
The
Certificate of Designation provides that from and after the Issuance Date and subject to the terms of the Certificate of Designation,
each share of Series B Preferred Stock is convertible, at any time and from time to time, at the option of the holder into a number of
shares of common stock equal to dividing the amount equal to the greater of the Stated Value of such Series B Preferred Stock, plus any
dividends declared but unpaid thereon, or such amount per share as would have been payable had each such share been converted into common
stock immediately prior to a liquidation, by six dollars ($6.00) (subject to adjustment in the event of any stock dividend, stock split,
combination, or other similar recapitalization affecting such shares). The aggregate number of shares of common stock that may be issued
through conversion of all of the New Investment Shares and Exchange Shares is 7,833,334 shares (subject to appropriate adjustment in
the event of any stock dividend, stock split, combination or other similar recapitalization affecting such shares).
Mandatory
Conversion
If
the Company consummates the sale of shares of common stock to the public in a firm-commitment underwritten public offering pursuant to
an effective registration statement under the Securities Act pursuant to which the price of the common stock in such offering is at least
equal to twelve dollars ($12.00) (subject to adjustment in the event of any stock dividend, stock split, combination, or other similar
recapitalization affecting such shares) and such offering does not include warrants (or any other convertible security) and results in
at least $25,000,000 in proceeds, net of the underwriting discount and commissions, to the Company, and the common stock continues to
be listed for trading on the Nasdaq Capital Market or another exchange, all outstanding shares of Series B Preferred Stock will automatically
be converted into shares of common stock, at the then effective Series B Conversion Ratio (as defined in the Certificate of Designation).
Liquidation
Upon
any voluntary or involuntary liquidation, dissolution or winding up of the Company or Deemed Liquidation (as defined in the Certificate
of Designation) (a “Liquidation”), the holders of shares of Series B Preferred Stock then outstanding will be entitled to
be paid out of the assets of the Company available for distribution to its stockholders (on a pari passu basis with the holders of any
class or series of preferred stock ranking on liquidation on a parity with the Series B Preferred Stock), and before any payment will
be made to the holders of common stock or any other class or series of preferred stock ranking on liquidation junior to the Series B
Preferred Stock by reason of their ownership thereof, an amount per share of Series B Preferred Stock equal to the greater of (i) the
Stated Value of such share of Series B Preferred Stock, plus any dividends declared but unpaid thereon, or (ii) such amount per share
as would have been payable had each such share been converted into common stock immediately prior to such Liquidation.
As
of June 30, 2024 and December 31, 2023, there were 47,000 issued and outstanding shares of Series B Preferred Stock, respectively.
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v3.24.2.u1
REVOLVING LINE OF CREDIT
|
6 Months Ended |
Jun. 30, 2024 |
Debt Disclosure [Abstract] |
|
REVOLVING LINE OF CREDIT |
16. REVOLVING LINE OF CREDIT
On
October 13, 2021, the Company and its subsidiaries entered into the Comerica Loan Agreement with Comerica, providing for a revolving
credit facility of up to $7,500,000 (the “Credit Facility”). The Company could use the proceeds of the Credit Facility for
working capital and other general corporate purposes.
On
October 6, 2023, effective September 30, 2023, the Company entered into a Fifth Amendment to its Loan and Security Agreement (the “Fifth
Amendment to the Comerica Loan Agreement”) with Comerica Bank providing for a revolving credit facility of up to $5,000,000.
In
February 2024, the Company terminated the Comerica Loan Agreement. The Company did not owe anything outstanding on the line of credit
at the time of termination and does not owe anything further to Comerica.
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v3.24.2.u1
RECENT ACCOUNTING STANDARDS
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Changes and Error Corrections [Abstract] |
|
RECENT ACCOUNTING STANDARDS |
17. RECENT ACCOUNTING STANDARDS
Accounting
Pronouncements Adopted
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 ASU 2020-06 amendments are effective for fiscal years beginning after December 15, 2023, and interim
periods within those fiscal years. This was adopted on January 1, 2024 and there was no impact upon adoption.
Accounting
Pronouncements Pending
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This ASU requires public
entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income
taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption
permitted. The Company is currently evaluating the impact the adoption of this standard on its financial statements.
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v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Accounting Estimates |
Accounting
Estimates
The
preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions
that affect the amounts of assets and liabilities reported and disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the reporting period. Management’s estimates are based on historical
experience, facts and circumstances available at the time, and various other assumptions that are believed to be reasonable under the
circumstances. Significant estimates include accounting for valuation allowances related to deferred income taxes, contingent consideration,
allowances for credit losses, revenue recognition, unrecognized tax benefits, and asset impairments involving intangible assets. The
Company periodically reviews these matters and reflects changes in estimates in earnings as appropriate. Actual results could materially
differ from those estimates.
|
Revenue Recognition |
Revenue
Recognition
We
derive our revenues from the performance of proprietary assays or tests. The Company’s performance obligation is fulfilled upon
the completion, review and release of test results to the customer. We subsequently bill third-party payers or direct-bill payers for
the tests performed. Under Accounting Standards Codification 606, revenue is recognized based on the estimated transaction price or net
realizable value, which is determined based on historical collection rates by each payer category for each proprietary test offered by
the Company. To the extent the transaction price includes variable consideration, for all third party and direct-bill payers and proprietary
tests, we estimate the amount of variable consideration that should be included in the transaction price using the expected value method
based on historical experience.
We
regularly review the ultimate amounts received from the third-party and direct-bill payers and related estimated reimbursement rates
and adjust the NRV’s and related contractual allowances accordingly. If actual collections and related NRV’s vary significantly
from our estimates, we will adjust the estimates of contractual allowances, which affects net revenue in the period such variances become
known.
|
Financing and Payment |
Financing
and Payment
For
non-Medicare claims, our payment terms vary by payer category. Payment terms for direct-payers in our clinical services are typically
thirty days and in our pharma services, were up to sixty days. Commercial third-party-payers are required to respond to a claim within
a time period established by their respective state regulations, generally between thirty to sixty days. However, payment for commercial
third-party claims may be subject to a denial and appeal process, which could take up to two years in some instances where multiple appeals
are submitted. The Company generally appeals all denials from commercial third-party payers. We bill Medicare directly for tests performed
for Medicare patients and must accept Medicare’s fee schedule for the covered tests as payment in full.
|
Costs to Obtain or Fulfill a Customer Contract |
Costs
to Obtain or Fulfill a Customer Contract
Sales
commissions are expensed in the period in which they have been earned. These costs are recorded in sales and marketing expense in the
condensed consolidated statements of operations.
|
Accounts Receivable |
Accounts
Receivable
The
Company’s accounts receivable represent unconditional rights to consideration and are generated using its clinical 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.
The allowance for credit losses balance was $26,000 and $0 at June 30, 2024 and December 31, 2023, respectively.
|
Leases |
Leases
The
Company determines if an arrangement contains a lease in whole or in part at the inception of the contract. Right-of-use (“ROU”)
assets represent the Company’s right to use an underlying asset for the lease term while lease liabilities represent our obligation
to make lease payments arising from the lease. All leases with terms greater than twelve months result in the recognition of a ROU asset
and a liability at the lease commencement date based on the present value of the lease payments over the lease term. Unless a lease provides
all of the information required to determine the implicit interest rate, we use our incremental borrowing rate based on the information
available at the commencement date in determining the present value of the lease payments. We use the implicit interest rate in the lease
when readily determinable.
Our
lease terms include all non-cancelable periods and may include options to extend (or to not terminate) the lease when it is reasonably
certain that we will exercise that option. Leases with terms of twelve months or less at the commencement date are expensed on a straight-line
basis over the lease term and do not result in the recognition of an asset or liability. See Note 7, Leases.
|
Other Current Assets |
Other
Current Assets
Other
current assets consisted of the following as of June 30, 2024 and December 31, 2023:
SCHEDULE
OF OTHER CURRENT ASSETS
| |
June 30, 2024 | | |
December 31, 2023 | |
Lab supplies | |
$ | 1,231 | | |
$ | 1,227 | |
Prepaid expenses | |
| 667 | | |
| 590 | |
Other | |
| 43 | | |
| 24 | |
Total other current assets | |
$ | 1,941 | | |
$ | 1,841 | |
|
Long-Lived Assets, including Finite-Lived Intangible Assets |
Long-Lived
Assets, including Finite-Lived Intangible Assets
Finite-lived
intangible assets are stated at cost less accumulated amortization. Amortization of finite-lived acquired intangible assets is recognized
on a straight-line basis, using the estimated useful lives of the assets of approximately two years to ten years in acquisition-related
amortization expense in the condensed consolidated statements of operations.
The
Company reviews the recoverability of long-lived assets and finite-lived intangible assets whenever events or changes in circumstances
indicate that the carrying value of such assets may not be recoverable. If the sum of the expected future undiscounted cash flows is
less than the carrying amount of the asset, an impairment loss is recognized by reducing the recorded value of the asset to its fair
value measured by future discounted cash flows. This analysis requires estimates of the amount and timing of projected cash flows and,
where applicable, judgments associated with, among other factors, the appropriate discount rate. Such estimates are critical in determining
whether any impairment charge should be recorded and the amount of such charge if an impairment loss is deemed to be necessary.
|
Basic and Diluted Net Income (Loss) per Share |
Basic
and Diluted Net Income (Loss) per Share
A
reconciliation of the number of shares of common stock, par value $0.01 per share, used in the calculation of basic and diluted income
(loss) per share for the three- and six-month periods ended June 30, 2024 and 2023 is as follows:
SCHEDULE
OF BASIC AND DILUTED NET LOSS PER SHARE
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Basic weighted average number of common shares | |
| 4,376 | | |
| 4,311 | | |
| 4,373 | | |
| 4,309 | |
Potential dilutive effect of stock-based awards | |
| 25 | | |
| 5 | | |
| 20 | | |
| 4 | |
Diluted weighted average number of common shares | |
| 4,401 | | |
| 4,316 | | |
| 4,393 | | |
| 4,313 | |
The
Company’s Series B Redeemable Preferred Stock, on an as converted basis into common stock of 7,833,334 shares for the three- and
six-months ended June 30, 2024, and the following outstanding stock-based awards, were excluded from the computation of the effect of
dilutive securities on income (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
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Options | |
| 288 | | |
| 475 | | |
| 288 | | |
| 475 | |
Restricted stock units (RSUs) | |
| 182 | | |
| 215 | | |
| 187 | | |
| 217 | |
Anti-dilutive
securities | |
| 470 | | |
| 690 | | |
| 475 | | |
| 692 | |
|
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v3.24.2.u1
DISCONTINUED OPERATIONS (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Discontinued Operations and Disposal Groups [Abstract] |
|
SCHEDULE OF COMPONENTS OF ASSETS AND LIABILITIES AND REVENUE CLASSIFIED AS DISCONTINUED |
The
table below presents the significant components of its former Pharma Solutions business unit’s results included within loss from
discontinued operations, net of tax in the condensed consolidated statements of operations for the three- and six months ended June 30,
2024 and 2023.
SCHEDULE
OF COMPONENTS OF ASSETS AND LIABILITIES AND REVENUE CLASSIFIED AS DISCONTINUED
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For The Three Months Ended | | |
For The Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Revenue, net | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Loss from discontinued operations | |
| - | | |
| (137 | ) | |
| - | | |
| (137 | ) |
Income tax expense | |
| 74 | | |
| 83 | | |
| 178 | | |
| 162 | |
Loss from discontinued operations, net of tax | |
$ | (74 | ) | |
$ | (220 | ) | |
$ | (178 | ) | |
$ | (299 | ) |
|
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v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
SCHEDULE OF OTHER CURRENT ASSETS |
Other
current assets consisted of the following as of June 30, 2024 and December 31, 2023:
SCHEDULE
OF OTHER CURRENT ASSETS
| |
June 30, 2024 | | |
December 31, 2023 | |
Lab supplies | |
$ | 1,231 | | |
$ | 1,227 | |
Prepaid expenses | |
| 667 | | |
| 590 | |
Other | |
| 43 | | |
| 24 | |
Total other current assets | |
$ | 1,941 | | |
$ | 1,841 | |
|
SCHEDULE OF BASIC AND DILUTED NET LOSS PER SHARE |
SCHEDULE
OF BASIC AND DILUTED NET LOSS PER SHARE
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Basic weighted average number of common shares | |
| 4,376 | | |
| 4,311 | | |
| 4,373 | | |
| 4,309 | |
Potential dilutive effect of stock-based awards | |
| 25 | | |
| 5 | | |
| 20 | | |
| 4 | |
Diluted weighted average number of common shares | |
| 4,401 | | |
| 4,316 | | |
| 4,393 | | |
| 4,313 | |
|
SCHEDULE OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE |
SCHEDULE
OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Options | |
| 288 | | |
| 475 | | |
| 288 | | |
| 475 | |
Restricted stock units (RSUs) | |
| 182 | | |
| 215 | | |
| 187 | | |
| 217 | |
Anti-dilutive
securities | |
| 470 | | |
| 690 | | |
| 475 | | |
| 692 | |
|
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v3.24.2.u1
FAIR VALUE MEASUREMENTS (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Fair Value Disclosures [Abstract] |
|
SCHEDULE OF FINANCIAL INSTRUMENT MEASURED ON RECURRING BASIS |
SCHEDULE
OF FINANCIAL INSTRUMENT MEASURED ON RECURRING BASIS
| |
As of June 30, 2024 | | |
Fair Value Measurements | |
| |
| | |
Fair | | |
As of June 30, 2024 | |
| |
Amount | | |
Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| | |
| |
Liabilities: | |
| | | |
| | | |
| | | |
| | | |
| | |
Contingent consideration: | |
| | | |
| | | |
| | | |
| | | |
| | |
Asuragen (1) | |
$ | 30 | | |
$ | 30 | | |
$ | - | | |
$ | - | | |
$ | 30 | |
Note payable: | |
| | | |
| | | |
| | | |
| | | |
| | |
BroadOak loan | |
| 7,400 | | |
| 6,784 | | |
| - | | |
| - | | |
| 6,784 | |
| |
$ | 7,430 | | |
$ | 6,814 | | |
$ | - | | |
$ | - | | |
$ | 6,814 | |
(1) |
See Note 9, Other Accrued Expenses |
| |
As of December 31, 2023 | | |
Fair Value Measurements | |
| |
Carrying | | |
Fair | | |
As of December 31, 2023 | |
| |
Amount | | |
Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Liabilities: | |
| | | |
| | | |
| | | |
| | | |
| | |
Contingent consideration: | |
| | | |
| | | |
| | | |
| | | |
| | |
Asuragen (1) | |
$ | 453 | | |
$ | 453 | | |
$ | - | | |
$ | - | | |
$ | 453 | |
Note payable: | |
| | | |
| | | |
| | | |
| | | |
| | |
BroadOak loan | |
| 10,000 | | |
| 9,343 | | |
| - | | |
| - | | |
| 9,343 | |
| |
$ | 10,453 | | |
$ | 9,796 | | |
$ | - | | |
$ | - | | |
$ | 9,796 | |
(1) |
See Note 9, Other Accrued Expenses |
|
SCHEDULE OF FAIR VALUE, ASSETS MEASURED ON RECURRING BASIS, UNOBSERVABLE INPUT RECONCILIATION |
A
roll forward of the carrying value of the Contingent Consideration Liability and BroadOak Loan to June 30, 2024 is as follows:
SCHEDULE
OF FAIR VALUE, ASSETS MEASURED ON RECURRING BASIS, UNOBSERVABLE INPUT RECONCILIATION
| |
| | |
| | |
| | |
| | |
Adjustment | | |
| |
| |
December 31,
2023 | | |
Payments | | |
Transferred
to Accrued
Expenses | | |
Accretion/
Interest Accrued | | |
to Fair Value/
Mark to
Market | | |
June 30,
2024 | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Asuragen | |
$ | 453 | | |
$ | - | | |
$ | (453 | ) | |
$ | 30 | | |
$ | - | | |
$ | 30 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
BroadOak loans | |
| 9,343 | | |
| (2,600 | ) | |
| - | | |
| - | | |
| 41 | | |
| 6,784 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
$ | 9,796 | | |
$ | (2,600 | ) | |
$ | (453 | ) | |
$ | 30 | | |
$ | 41 | | |
$ | 6,814 | |
|
X |
- DefinitionTabular disclosure of the fair value measurement of assets using significant unobservable inputs (Level 3), a reconciliation of the beginning and ending balances, separately presenting changes during the period attributable to the following: (1) total gains or losses for the period (realized and unrealized), segregating those gains or losses included in earnings (or changes in net assets) and gains or losses recognized in other comprehensive income (loss), and a description of where those gains or losses included in earnings (or changes in net assets) are reported in the statement of income (or activities); (2) purchases, sales, issues, and settlements (each type disclosed separately); and (3) transfers in and transfers out of Level 3 (for example, transfers due to changes in the observability of significant inputs), by class of asset.
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v3.24.2.u1
LEASES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Leases |
|
SCHEDULE OF LEASE RELATED ASSETS AND LIABILITIES |
The
table below presents the lease-related assets and liabilities recorded in the Condensed Consolidated Balance Sheet:
SCHEDULE
OF LEASE RELATED ASSETS AND LIABILITIES
| |
Classification on the Balance Sheet | |
June 30, 2024 | | |
December 31, 2023 | |
| |
| |
| | |
| |
Assets | |
| |
| | | |
| | |
Operating lease assets | |
Operating lease right of use assets | |
| 1,635 | | |
| 1,864 | |
Total lease assets | |
| |
$ | 1,635 | | |
$ | 1,864 | |
| |
| |
| | | |
| | |
Liabilities | |
| |
| | | |
| | |
Current | |
| |
| | | |
| | |
Operating lease liabilities | |
Other accrued expenses | |
| 319 | | |
| 377 | |
Total current lease liabilities | |
| |
$ | 319 | | |
$ | 377 | |
Noncurrent | |
| |
| | | |
| | |
Operating lease liabilities | |
Operating lease liabilities, net of current portion | |
| 1,286 | | |
| 1,472 | |
Total long-term lease liabilities | |
| |
| 1,286 | | |
| 1,472 | |
Total lease liabilities | |
| |
$ | 1,605 | | |
$ | 1,849 | |
|
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES |
The
table below reconciles the cash flows to the lease liabilities recorded on the Company’s Condensed Consolidated Balance Sheet as
of June 30, 2024:
SCHEDULE
OF MATURITIES OF OPERATING LEASE LIABILITIES
| |
Operating Leases | |
2024 - remaining six months | |
$ | 268 | |
2025 | |
| 450 | |
2026 | |
| 500 | |
2027 | |
| 550 | |
2028 | |
| 275 | |
Total minimum lease payments | |
| 2,043 | |
Less: amount of lease payments representing effects of discounting | |
| 438 | |
Present value of future minimum lease payments | |
| 1,605 | |
Less: current obligations under leases | |
| 319 | |
Long-term lease obligations | |
$ | 1,286 | |
|
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v3.24.2.u1
OTHER ACCRUED EXPENSES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Payables and Accruals [Abstract] |
|
SCHEDULE OF OTHER ACCRUED EXPENSES |
Other
accrued expenses consisted of the following as of June 30, 2024 and December 31, 2023:
SCHEDULE OF OTHER ACCRUED EXPENSES
| |
June 30, 2024 | | |
December 31, 2023 | |
Accrued royalties | |
$ | 7,010 | | |
$ | 6,268 | |
Contingent consideration | |
| 30 | | |
| 453 | |
Operating lease liability | |
| 319 | | |
| 377 | |
Accrued sales and marketing - diagnostics | |
| 28 | | |
| 43 | |
Accrued lab costs - diagnostics | |
| 103 | | |
| 68 | |
Accrued professional fees | |
| 162 | | |
| 241 | |
Taxes payable | |
| 308 | | |
| 261 | |
All others | |
| 622 | | |
| 490 | |
Total other accrued expenses | |
$ | 8,582 | | |
$ | 8,201 | |
|
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SUPPLEMENTAL CASH FLOW INFORMATION (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Supplemental Cash Flow Elements [Abstract] |
|
SUPPLEMENTAL CASH FLOW INFORMATION |
Supplemental
Disclosures of Non-Cash Activities
(in
thousands)
SUPPLEMENTAL CASH FLOW INFORMATION
| |
2024 | | |
2023 | |
| |
Six Months Ended | |
| |
June 30, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Taxes accrued for repurchase of restricted shares | |
$ | 16 | | |
$ | 9 | |
Purchase of property and equipment included in accounts payable | |
| 230 | | |
| 29 | |
|
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v3.24.2.u1
LIQUIDITY (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
|
|
|
|
|
|
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Aug. 02, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
May 31, 2022 |
Oct. 31, 2021 |
Oct. 29, 2021 |
Line of Credit Facility [Line Items] |
|
|
|
|
|
|
|
|
|
|
Operating income from continuing operation |
$ 2,257,000
|
$ 832,000
|
$ 3,131,000
|
$ 1,508,000
|
|
|
|
|
|
|
Cash and cash equivalents |
2,019,000
|
$ 5,079,000
|
2,019,000
|
$ 5,079,000
|
|
$ 3,498,000
|
$ 4,828,000
|
|
|
|
Current assets |
10,166,000
|
|
10,166,000
|
|
|
10,322,000
|
|
|
|
|
Current liabilities |
19,030,000
|
|
19,030,000
|
|
|
17,474,000
|
|
|
|
|
Cash and cash equivalents |
$ 2,019,000
|
|
$ 2,019,000
|
|
|
$ 3,498,000
|
|
|
|
|
Subsequent Event [Member] |
|
|
|
|
|
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
|
|
$ 1,800,000
|
|
|
|
|
|
Term Loan [Member] | Broad Oak [Member] |
|
|
|
|
|
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
|
|
|
|
|
Term loan |
|
|
|
|
|
|
|
$ 2,000,000.0
|
$ 8,000,000.0
|
$ 8,000,000
|
Term Loan [Member] | Broad Oak [Member] | Convertible Debt [Member] |
|
|
|
|
|
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
|
|
|
|
|
Term loan |
|
|
|
|
|
|
|
$ 2,000,000.0
|
|
|
Comerica Bank [Member] |
|
|
|
|
|
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
|
|
|
|
|
Long-term line of credit |
|
|
|
|
|
|
|
|
$ 7,500,000
|
|
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SCHEDULE OF BASIC AND DILUTED NET LOSS PER SHARE (Details) - shares shares in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
|
|
|
Basic weighted average number of common shares |
4,376
|
4,311
|
4,373
|
4,309
|
Potential dilutive effect of stock-based awards |
25
|
5
|
20
|
4
|
Diluted weighted average number of common shares |
4,401
|
4,316
|
4,393
|
4,313
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v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
|
|
Jun. 30, 2024 |
Jun. 30, 2024 |
Dec. 31, 2023 |
Jun. 30, 2023 |
Property, Plant and Equipment [Line Items] |
|
|
|
|
Allowance for credit losses |
$ 26,000
|
$ 26,000
|
$ 0
|
|
Common stock, par value |
$ 0.01
|
$ 0.01
|
$ 0.01
|
$ 0.01
|
Series B Preferred Stock [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Number of preferred stocks on converted basis |
7,833,334
|
7,833,334
|
|
|
Minimum [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Finite lived intangible asset, useful life |
2 years
|
2 years
|
|
|
Maximum [Member] |
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
Finite lived intangible asset, useful life |
10 years
|
10 years
|
|
|
X |
- DefinitionAmount of allowance for credit loss on accounts receivable, classified as current.
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v3.24.2.u1
SCHEDULE OF FINANCIAL INSTRUMENT MEASURED ON RECURRING BASIS (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Notes payable |
|
|
$ 4,243
|
|
Fair value of liabilities |
7,430
|
|
10,453
|
|
Fair Value Measured at Net Asset Value Per Share [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Fair value of liabilities |
6,814
|
|
9,796
|
|
Fair Value, Inputs, Level 1 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Fair value of liabilities |
|
|
|
|
Fair Value, Inputs, Level 2 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Fair value of liabilities |
|
|
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Fair value of liabilities |
6,814
|
|
9,796
|
|
Asuragen [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Contingent consideration |
30
|
[1] |
453
|
[2] |
Asuragen [Member] | Fair Value Measured at Net Asset Value Per Share [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Contingent consideration |
30
|
[1] |
453
|
[2] |
Asuragen [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
|
|
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|
|
|
|
Contingent consideration |
|
[1] |
|
[2] |
Asuragen [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Contingent consideration |
|
[1] |
|
[2] |
Asuragen [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Contingent consideration |
30
|
[1] |
453
|
[2] |
BroadOak Loan [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Notes payable |
7,400
|
|
10,000
|
|
BroadOak Loan [Member] | Fair Value Measured at Net Asset Value Per Share [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Notes payable |
6,784
|
|
9,343
|
|
BroadOak Loan [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Notes payable |
|
|
|
|
BroadOak Loan [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
|
|
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|
|
|
|
Notes payable |
|
|
|
|
BroadOak Loan [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Notes payable |
$ 6,784
|
|
$ 9,343
|
|
|
|
X |
- DefinitionAmount of liability recognized arising from contingent consideration in a business combination.
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v3.24.2.u1
SCHEDULE OF LEASE RELATED ASSETS AND LIABILITIES (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Leases |
|
|
Operating lease assets |
$ 1,635
|
$ 1,864
|
Total lease assets |
1,635
|
1,864
|
Operating lease, liability, current |
319
|
377
|
Total current lease liabilities |
319
|
377
|
Operating lease, liability, noncurrent |
1,286
|
1,472
|
Total long-term lease liabilities |
1,286
|
1,472
|
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$ 1,605
|
$ 1,849
|
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SCHEDULE OF SHARE-BASED COMPENSATION ARRANGEMENTS BY SHARE-BASED PAYMENT AWARD (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total stock compensation expense |
$ 53
|
$ 157
|
$ 132
|
$ 349
|
Cost of Sales [Member] |
|
|
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total stock compensation expense |
|
12
|
4
|
26
|
Selling and Marketing Expense [Member] |
|
|
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total stock compensation expense |
23
|
30
|
53
|
60
|
General and Administrative Expense [Member] |
|
|
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total stock compensation expense |
$ 30
|
$ 115
|
$ 75
|
$ 263
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v3.24.2.u1
v3.24.2.u1
NOTES PAYABLE (Details Narrative) - USD ($)
|
Apr. 01, 2024 |
Mar. 29, 2024 |
Nov. 01, 2023 |
Oct. 30, 2023 |
Oct. 24, 2023 |
Oct. 29, 2021 |
Jun. 30, 2024 |
Oct. 31, 2023 |
May 31, 2022 |
Oct. 31, 2021 |
Line of Credit Facility [Line Items] |
|
|
|
|
|
|
|
|
|
|
Loan outstanding |
|
|
|
|
|
|
$ 7,400,000
|
|
|
|
BroadOak Loan Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
|
|
|
|
|
Loan maturity date |
|
|
Oct. 31, 2024
|
|
|
|
|
|
|
|
Debt interest percentage |
|
|
8.00%
|
|
|
|
|
9.00%
|
|
|
Monthly payments |
|
|
|
$ 2,500,000
|
|
|
|
|
|
|
Terminal payment |
|
|
|
|
$ 3,000,000
|
|
|
|
|
|
Loan and Security Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
|
|
|
|
|
Monthly payments |
$ 500,000,000
|
|
|
|
|
|
|
|
|
|
Maturity date extended |
|
The maturity date was extended
to June 30, 2025.
|
|
|
|
|
|
|
|
|
Comerica Bank [Member] |
|
|
|
|
|
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
|
|
|
|
|
Revolving credit facility |
|
|
|
|
|
|
|
|
|
$ 7,500,000
|
Comerica Bank [Member] | Revolving Credit Facility [Member] |
|
|
|
|
|
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
|
|
|
|
|
Revolving credit facility |
|
|
|
|
|
$ 7,500,000
|
|
|
|
|
Debt instrument interest, description |
|
|
|
|
|
The Term Loan
had an origination fee of 3% of the Term Loan amount, and a terminal payment equal to (i) 15% of the original principal amount of the
Term Loan if the change of control occurs on or prior to the first anniversary of the funding of the Term Loan, (ii) 20% of the original
principal amount of the Term Loan if the change of control occurs after the first anniversary but on or prior to the second anniversary
of the funding of the Term Loan and (iii) 30% of the original principal amount of the Term Loan if the change of control occurs after
the second anniversary of the funding of the Term Loan, or if the Term Loan is repaid on its maturity date.
|
|
|
|
|
Term Loan [Member] | Broad Oak [Member] |
|
|
|
|
|
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
|
|
|
|
|
Debt instrument, face amount |
|
|
|
|
|
$ 8,000,000
|
|
|
$ 2,000,000.0
|
$ 8,000,000.0
|
Term Loan [Member] | Ampersand 2018 [Member] |
|
|
|
|
|
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
|
|
|
|
|
Loan maturity date |
|
|
|
|
|
Oct. 31, 2024
|
|
|
|
|
Debt interest percentage |
|
|
|
|
|
9.00%
|
|
|
|
|
Percentage of debt origination fee |
|
|
|
|
|
3.00%
|
|
|
|
|
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v3.24.2.u1
MEZZANINE EQUITY (Details Narrative) - USD ($)
|
|
3 Months Ended |
6 Months Ended |
|
Jan. 10, 2020 |
Mar. 31, 2024 |
Mar. 31, 2023 |
Jun. 30, 2024 |
Dec. 31, 2023 |
Class of Stock [Line Items] |
|
|
|
|
|
Preferred stock aggregate purchase price |
|
|
|
|
|
Preferred stock liquidation preference |
|
|
|
$ 6.00
|
|
Proceeds from underwriting discount and commission |
|
|
|
$ 25,000,000
|
|
Common Stock [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Preferred stock aggregate purchase price |
|
$ 1,000
|
|
|
|
Aggregate of shares issued |
|
39,668
|
22,996
|
|
|
Reserve stock split |
|
|
|
7,833,334
|
|
Sale of stock price per share |
|
|
|
$ 12.00
|
|
Series B Preferred Stock [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Aggregate of shares issued |
27,000
|
|
|
|
|
Preferred stock conversion price per share |
$ 6.00
|
|
|
|
|
Maximum preferred stock holders rights percentage |
|
|
|
The
Certificate of Designation also provides each Investor with the following director designation rights: for so long such Investor holds
at least sixty percent (60%) of the Series B Preferred Stock issued to it on the Issuance Date (as defined therein), such Investor will
be entitled to elect two directors to the Company’s Board of Directors (the “Board”), provided that one of the directors
qualifies as an “independent director” under Rule 5605(a)(2) of the listing rules of the Nasdaq Stock Market (or any successor
rule or similar rule promulgated by another exchange on which the Company’s securities are then listed or designated) (“Independent
Director”). However, if at any time such Investor holds less than sixty percent (60%), but at least forty percent (40%), of the
Series B Preferred Stock issued to them on the Issuance Date, such Investor would only be entitled to elect one director to the Board.
Any director elected pursuant to the terms of the Certificate of Designation may be removed without cause by, and only by, the affirmative
vote of the holders of Series B Preferred Stock. A vacancy in any directorship filled by the holders of Series B Preferred Stock may
be filled only by vote or written consent in lieu of a meeting of such holders of Series B Preferred Stock or by any remaining director
or directors elected by such holders of Series B Preferred Stock.
|
|
Temporary equity shares issued |
|
|
|
47,000
|
47,000
|
Temporary equity shares outstanding |
|
|
|
47,000
|
47,000
|
Series A Preferred Stock [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Aggregate of shares issued |
270
|
|
|
|
|
Value of preferred stock exchanged |
$ 27,000,000.0
|
|
|
|
|
Preferred stock par value per share |
$ 0.01
|
|
|
|
|
Preferred shares stated value per share |
$ 100,000
|
|
|
|
|
Preferred stock shares authorized |
0
|
|
|
|
|
Preferred stock shares issued |
0
|
|
|
|
|
Preferred stock shares outstanding |
0
|
|
|
|
|
Security Purchase and Exchange Agreement [Member] | Series B Preferred Stock [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Preferred stock aggregate purchase price |
$ 20,000,000.0
|
|
|
|
|
Issuance price per preferred stock |
$ 1,000
|
|
|
|
|
Security Purchase and Exchange Agreement [Member] | Series B Preferred Stock [Member] | 1315 Capital [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Preferred stock aggregate purchase price |
$ 19,000,000.0
|
|
|
|
|
Aggregate of shares issued |
19,000
|
|
|
|
|
Security Purchase and Exchange Agreement [Member] | Series B Preferred Stock [Member] | Ampersand 2018 Limited Partnership [Member] |
|
|
|
|
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Class of Stock [Line Items] |
|
|
|
|
|
Preferred stock aggregate purchase price |
$ 1,000,000.0
|
|
|
|
|
Aggregate of shares issued |
1,000
|
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|
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- DefinitionThe carrying value as of the balance sheet date of the current and noncurrent portions of long-term obligations drawn from a line of credit, which is a bank's commitment to make loans up to a specific amount. Examples of items that might be included in the application of this element may consist of letters of credit, standby letters of credit, and revolving credit arrangements, under which borrowings can be made up to a maximum amount as of any point in time conditional on satisfaction of specified terms before, as of and after the date of drawdowns on the line. Includes short-term obligations that would normally be classified as current liabilities but for which (a) postbalance sheet date issuance of a long term obligation to refinance the short term obligation on a long term basis, or (b) the enterprise has entered into a financing agreement that clearly permits the enterprise to refinance the short-term obligation on a long term basis and the following conditions are met (1) the agreement does not expire within 1 year and is not cancelable by the lender except for violation of an objectively determinable provision, (2) no violation exists at the BS date, and (3) the lender has entered into the financing agreement is expected to be financially capable of honoring the agreement.
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- DefinitionLine items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.
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Interpace Biosciences (QX) (USOTC:IDXG)
過去 株価チャート
から 8 2024 まで 9 2024
Interpace Biosciences (QX) (USOTC:IDXG)
過去 株価チャート
から 9 2023 まで 9 2024