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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(D) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date
of Report (Date of earliest event reported): November 8, 2023
INTERPACE
BIOSCIENCES, INC.
(Exact
name of Registrant as specified in its charter)
delaware |
|
0-24249 |
|
22-2919486 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
Waterview
Plaza, Suite 310
2001
Route 46,
Parsippany,
NJ 07054
(Address,
including zip code, of Principal Executive Offices)
(855)
776-6419
Registrant’s
telephone number, including area code
Not
Applicable
(Former
name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐ |
Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
None |
|
N/A |
|
N/A |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
☐
Emerging growth company
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
2.02 Results of Operations and Financial Condition.
On
November 8, 2023, Interpace Biosciences, Inc. issued a press release announcing its results of operations and financial condition for
the quarter ended September 30, 2023. The full text of the press release is set forth as Exhibit 99.1 attached hereto and is incorporated
herein by reference.
The
information in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed “filed”
for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject
to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any registration statement or other document
filed under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise stated in such filing.
Item
9.01. Financial Statements and Exhibits.
(d)
Exhibits.
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
|
Interpace Biosciences, Inc. |
|
|
|
|
By: |
/s/ Thomas
W. Burnell |
|
Name: |
Thomas W. Burnell |
|
Title: |
President and Chief Executive Officer |
Date:
November 8, 2023
Exhibit
99.1
Interpace
Biosciences Announces Record Third Quarter 2023 Financial and Business Results
|
● |
Q3
Revenue of $9.1 million; an 11% increase year-over-year |
|
|
|
|
● |
Q3
Test volume up 11% year-over-year |
|
|
|
|
● |
Q3
Reimbursement improvement up 11% year-over-year, driven by additional commercial contracts and collection initiatives |
PARSIPPANY,
NJ, November 8, 2023 (GLOBE NEWSWIRE) — Interpace Biosciences, Inc. (“Interpace” or the “Company”)
(OTCQX: IDXG) today announced financial results for the third quarter ended September 30, 2023 and provided a business and financial
update.
Third
quarter Net Revenue was $9.1 million, a $0.9 million increase over third quarter 2022. Loss from continuing operations in the third quarter
of 2023 was $0.5 million, an improvement of $0.7 million from the prior-year quarter’s loss of $1.3 million. On an adjusted basis,
EDITDA was $0.4 million in Q3 and $2.9 million for YTD 2023. Net of previously reported one-time charges, YTD adjusted EBITDA is $3.9
million vs a YTD 2022 loss of $1.8 million.
Q3
represented the 3rd consecutive quarter of double-digit volume and revenue growth in 2023 compared to 2022, according to Chris
McCarthy, Chief Financial Officer. Tom Burnell, President and CEO, added, “in part due to expansion of test utilization by physicians,
the execution of new and re-negotiated commercial contracts, as well as overall price improvement, the cash position of the Company allowed
for the full re-payment of $2.5 million that was outstanding on the Company’s Line of Credit with Comerica Bank.” Additionally,
Burnell said, “in an effort to continue to improve the Company’s balance sheet, we fully satisfied the $3 million Terminal
Payment owed to BroadOak Capital Partners as part of our long-term debt agreement.” The Company was also able to re-negotiate the
terms of the LTD, significantly reducing the cost of capital. Finally, Burnell added, “the resiliency of our team is second-to-none.
They have endured restructuring, reimbursement challenges, and the shedding of non-performing assets all while optimizing operational
efficiency and overall growth of superior molecular diagnostics for assessing the risk of pancreatic and thyroid cancers.” The
Company announced that it expects full-year 2023 revenue to exceed $40 million.
Third
Quarter and 2023 Financial Performance
For
the Third Quarter of 2023 as Compared to the Third Quarter of 2022
|
● |
Net
Revenue was $9.1 million, an increase of 11% from $8.2 million for the prior-year quarter |
|
|
|
|
● |
Gross
Profit percentage was 55% compared to 58% for the prior-year quarter |
|
|
|
|
● |
Operating
loss was $(0.02) million vs an operating loss of $(0.8) million in the prior-year quarter |
|
|
|
|
● |
A
loss from continuing operations was $(0.5) million vs a loss from continuing operations of $(1.3) million in the prior-year quarter |
|
|
|
|
● |
Adjusted
EBITDA was $0.4 million vs $0.1 million in the prior-year quarter |
|
|
|
|
● |
Q3
2023 cash collections totaled $9.8 million vs $7.6 million for Q3 2022 |
|
|
|
|
● |
September
30, 2023 cash balance of $5.0 million |
For
the Nine Months Ended September 30, 2023 as Compared to the Nine Months Ended September 30, 2022
|
● |
Net
Revenue was $29.9 million, an increase of 27% from $23.5 million for the prior year |
|
|
|
|
● |
Gross
Profit percentage was 59% compared to 56% for the prior-year quarter, and improved 5% vs 2022 |
|
|
|
|
● |
Income
from continuing operations was $0.3 million vs a loss from continuing operations of $(4.5) million in the prior year |
|
|
|
|
● |
Adjusted
EBITDA was $2.9 million vs $(1.8) million loss in the prior year |
About
Interpace Biosciences
Interpace
Biosciences is an emerging leader in enabling personalized medicine, offering specialized services along the therapeutic value chain
from early diagnosis and prognostic planning to targeted therapeutic applications.
Clinical
services, through Interpace Diagnostics, provide clinically useful molecular diagnostic tests and bioinformatics and pathology services
for evaluating risk of cancer by leveraging the latest technology in personalized medicine for improved patient diagnosis and management.
Interpace has five commercialized molecular tests and one test in a clinical evaluation program (CEP): PancraGEN® for
the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; PanDNA®, a “molecular only” version
of PancraGEN that provides physicians a snapshot of a limited number of factors; ThyGeNEXT® for the diagnosis of thyroid
cancer from thyroid nodules utilizing a next-generation sequencing assay; ThyraMIR®v2, used in combination with ThyGeNEXT®,
for the diagnosis of thyroid cancer utilizing a proprietary microRNA pairwise expression profiler along with algorithmic classification;
and RespriDX®, that differentiates lung cancer of primary versus metastatic origin. In addition, BarreGEN®,
a molecular-based assay that helps resolve the risk of progression of Barrett’s Esophagus to esophageal cancer, is currently in
a CEP, whereby we gather information from physicians using BarreGEN to assist us in gathering clinical evidence relative to the safety
and performance of the test and also providing data that will potentially support payer reimbursement.
For
more information, please visit Interpace Biosciences’ website at www.interpace.com.
Forward-looking
Statements
This
press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the
Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to the Company’s future financial
and operating performance. The Company has attempted to identify forward-looking statements by terminology including “believes,”
“estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,”
“potential,” “may,” “could,” “might,” “will,” “should,” “approximately”
or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are
based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive
and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which
are beyond the Company’s control. These statements also involve known and unknown risks, uncertainties and other factors that may
cause the Company’s actual results to be materially different from those expressed or implied by any forward-looking statements,
including, but not limited to, the reimbursement of the Company’s tests being subject to review by CMS, the Company’s ability
to continue to perform, bill and receive reimbursement for our PancraGEN® molecular test under the existing local coverage
determination (“LCD”), given that such LCD is currently under review by Novitas Solutions, Inc., the Company’s Medicare
administrative contractor, the possibility that the Company’s estimates of future revenue, cash flows and adjusted EBITDA may prove
to be materially inaccurate, the Company’s history of operating losses, the Company’s ability to adequately finance its business
and seek alternative sources of financing, the Company’s ability to repay borrowings with Comerica Bank and BroadOak, the Company’s
dependence on sales and reimbursements from its clinical services, the Company’s ability to retain or secure reimbursement including
its reliance on third parties to process and transmit claims to payers and the adverse impact of any delay, data loss, or other disruption
in processing or transmitting such claims, the Company’s revenue recognition being based in part on estimates for future collections
which estimates may prove to be incorrect, and the possible removal of the Company’s common stock from trading on the OTCQX®.
Additionally,
all forward-looking statements are subject to the “Risk Factors” detailed from time to time in the Company’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2022, as amended, Current Reports on Form 8-K and Quarterly Reports on Form
10-Q filed with the Securities and Exchange Commission. Because of these and other risks, uncertainties and assumptions, undue reliance
should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release
and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements
for any reason.
Contacts:
Investor
Relations
Interpace
Biosciences, Inc.
(855)-776-6419
Info@Interpace.com
INTERPACE
BIOSCIENCES, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited,
in thousands, except per share data)
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Revenue, net | |
$ | 9,078 | | |
$ | 8,189 | | |
$ | 29,931 | | |
$ | 23,506 | |
Cost of revenue | |
| 4,124 | | |
| 3,457 | | |
| 12,163 | | |
| 10,286 | |
Gross Profit | |
| 4,954 | | |
| 4,732 | | |
| 17,768 | | |
| 13,220 | |
| |
| | | |
| | | |
| | | |
| | |
Sales and marketing | |
| 2,498 | | |
| 2,236 | | |
| 7,444 | | |
| 6,987 | |
Research and development | |
| 149 | | |
| 191 | | |
| 484 | | |
| 626 | |
General and administrative | |
| 2,124 | | |
| 2,767 | | |
| 7,515 | | |
| 8,636 | |
Acquisition amortization expense | |
| 199 | | |
| 318 | | |
| 834 | | |
| 953 | |
Change in fair value of contingent consideration | |
| - | | |
| - | | |
| - | | |
| (311 | ) |
Total operating expenses | |
| 4,970 | | |
| 5,512 | | |
| 16,277 | | |
| 16,891 | |
| |
| | | |
| | | |
| | | |
| | |
Operating (loss) income | |
| (16 | ) | |
| (780 | ) | |
| 1,491 | | |
| (3,671 | ) |
Interest accretion expense | |
| (26 | ) | |
| (38 | ) | |
| (92 | ) | |
| (123 | ) |
Note payable interest | |
| (230 | ) | |
| (230 | ) | |
| (682 | ) | |
| (620 | ) |
Other expense, net | |
| (252 | ) | |
| (217 | ) | |
| (408 | ) | |
| (20 | ) |
(Loss) income from continuing operations before tax | |
| (524 | ) | |
| (1,265 | ) | |
| 309 | | |
| (4,434 | ) |
Provision (benefit) for income taxes | |
| 4 | | |
| (11 | ) | |
| 12 | | |
| 24 | |
(Loss) income from continuing operations | |
| (528 | ) | |
| (1,254 | ) | |
| 297 | | |
| (4,458 | ) |
| |
| | | |
| | | |
| | | |
| | |
Loss from discontinued operations, net of tax | |
| (86 | ) | |
| (12,954 | ) | |
| (385 | ) | |
| (15,936 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (614 | ) | |
$ | (14,208 | ) | |
$ | (88 | ) | |
$ | (20,394 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic (loss) income per share of common stock: | |
| | | |
| | | |
| | | |
| | |
From continuing operations | |
$ | (0.12 | ) | |
$ | (0.30 | ) | |
$ | 0.07 | | |
$ | (1.05 | ) |
From discontinued operations | |
| (0.02 | ) | |
| (3.05 | ) | |
| (0.09 | ) | |
| (3.77 | ) |
Net loss per basic share of common stock | |
$ | (0.14 | ) | |
$ | (3.35 | ) | |
$ | (0.02 | ) | |
$ | (4.82 | ) |
| |
| | | |
| | | |
| | | |
| | |
Diluted (loss) income per share of common stock: | |
| | | |
| | | |
| | | |
| | |
From continuing operations | |
$ | (0.12 | ) | |
$ | (0.30 | ) | |
$ | 0.07 | | |
$ | (1.05 | ) |
From discontinued operations | |
| (0.02 | ) | |
| (3.05 | ) | |
| (0.09 | ) | |
| (3.77 | ) |
Net loss per diluted share of common stock | |
$ | (0.14 | ) | |
$ | (3.35 | ) | |
$ | (0.02 | ) | |
$ | (4.82 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average number of common shares and
common share equivalents outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic | |
| 4,319 | | |
| 4,242 | | |
| 4,313 | | |
| 4,227 | |
Diluted | |
| 4,319 | | |
| 4,242 | | |
| 4,355 | | |
| 4,227 | |
Selected
Balance Sheet Data (Unaudited)
($
in thousands)
| |
September 30, 2023 | | |
December 31, 2022 | |
Cash and cash equivalents | |
$ | 5,032 | | |
$ | 4,828 | |
| |
| | | |
| | |
Total current assets | |
| 11,438 | | |
| 12,154 | |
Total current liabilities | |
| 12,324 | | |
| 14,283 | |
| |
| | | |
| | |
Total assets | |
| 14,250 | | |
| 15,979 | |
Total liabilities | |
| 30,394 | | |
| 32,515 | |
Total stockholders’ deficit | |
| (62,680 | ) | |
| (63,072 | ) |
Selected
Cash Flow Data (Unaudited)
($
in thousands)
| |
For the Nine Months Ended | |
| |
September 30, | |
| |
2023 | | |
2022 | |
Net loss | |
$ | (88 | ) | |
$ | (20,394 | ) |
| |
| | | |
| | |
Net cash provided (used in) operating activities | |
$ | 2,649 | | |
$ | (7,416 | ) |
Net cash provided by investing activities | |
| 55 | | |
| 7,305 | |
Net cash (used in) provided by financing activities | |
| (2,500 | ) | |
| 3,106 | |
Change in cash, cash equivalents and restricted cash | |
| 204 | | |
| 2,995 | |
Cash, cash equivalents and restricted cash – beginning | |
| 4,828 | | |
| 3,314 | |
Cash, cash equivalents and restricted cash – ending | |
$ | 5,032 | | |
$ | 6,309 | |
Reconciliation
of Adjusted EBITDA (Unaudited)
($
in thousands)
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
(Loss) income from continuing operations (GAAP Basis) | |
$ | (528 | ) | |
$ | (1,254 | ) | |
$ | 297 | | |
$ | (4,458 | ) |
Depreciation and amortization | |
| 241 | | |
| 353 | | |
| 954 | | |
| 1,076 | |
Stock-based compensation | |
| 152 | | |
| 501 | | |
| 501 | | |
| 1,110 | |
Tax expense (benefit) | |
| 4 | | |
| (11 | ) | |
| 12 | | |
| 24 | |
Interest accretion expense | |
| 26 | | |
| 38 | | |
| 92 | | |
| 123 | |
Note payable interest | |
| 230 | | |
| 230 | | |
| 682 | | |
| 620 | |
Mark to market on warrant liability | |
| - | | |
| (3 | ) | |
| - | | |
| (71 | ) |
Change in fair value of note payable | |
| 259 | | |
| 206 | | |
| 400 | | |
| 46 | |
Change in fair value of contingent consideration | |
| - | | |
| - | | |
| - | | |
| (311 | ) |
Adjusted EBITDA | |
$ | 384 | | |
$ | 60 | | |
$ | 2,938 | | |
$ | (1,841 | ) |
Non-GAAP
Financial Measures
In
addition to the United States generally accepted accounting principles, or GAAP, results provided throughout this document, we have provided
certain non-GAAP financial measures to help evaluate the results of our performance. We believe that these non-GAAP financial measures,
when presented in conjunction with comparable GAAP financial measures, are useful to both management and investors in analyzing our ongoing
business and operating performance. We believe that providing the non-GAAP information to investors, in addition to the GAAP presentation,
allows investors to view our financial results in the way that management views financial results.
In
this document, we discuss Adjusted EBITDA, a non-GAAP financial measure. Adjusted EBITDA is a metric used by management to measure cash
flow of the ongoing business. Adjusted EBITDA is defined as income or loss from continuing operations, plus depreciation and amortization,
non-cash stock based compensation and ESPP plans, interest and taxes, and other non-cash expenses including change in fair values of
notes payable, contingent consideration and warrant liability. The table above includes a reconciliation of this non-GAAP financial measure
to the most directly comparable GAAP financial measure.
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