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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): August
1, 2024
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
August 1, 2024, Interpace Biosciences, Inc. issued a press release announcing its results of operations and financial condition for the
second quarter ended June 30, 2024. 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:
August 2, 2024
Exhibit
99.1
Interpace
Biosciences Announces Record Second Quarter 2024 Financial and Business Results
|
● |
Q2
Revenue of $12.0 million; a $1.0M and 9% increase year-over-year |
|
● |
Q2
Test volume up 12% year-over-year to record levels |
|
● |
Q2
Cash collections of $11.0M; a $0.7M and 7% increase year-over-year |
|
● |
Q2
Volume, Revenue, and Profitability at all-time record levels |
PARSIPPANY,
NJ, Aug 1, 2024 (GLOBE NEWSWIRE) — Interpace Biosciences, Inc. (“Interpace” or the “Company”) (OTCQX:
IDXG) today announced financial results for the second quarter ended June 30, 2024 and provided a business and financial update.
Second
quarter Net Revenue was $12.0 million. Operating expenses for the second quarter were approximately 14% lower than the same period of
2023. Income from continuing operations in the second quarter of 2024 was $2.1 million, an improvement from the prior-year quarter of
$1.7 million. “The Company achieved record test volume, revenue, and cash collections, while reducing operating expenses, in the
second quarter of 2024. Test volume, test revenue, and cash collections increased over the prior-year quarter, driven by increased volume
and collection initiatives,” said Chris McCarthy, Chief Financial Officer. “The cash position of the Company allowed for
additional investments in our sales force, while simultaneously improving income from continuing operations. This also supported additional
principal payments on our long-term debt agreement, continuing to improve the Company’s balance sheet.” McCarthy added.
“Q2
2024 represented record testing volume for the Company, resulting in the achievement of continued profitability and positive cash flow,”
stated Tom Burnell, President and CEO. “Continued adoption of the Company’s proprietary molecular diagnostics tests (ThyGeNEXT®
+ ThyraMIR®v2 and PancraGEN®) by physicians and medical professionals has fueled the continued growth
trajectory of the Company.” Burnell added, “Q2 2024 marked the sixteenth consecutive quarter of year-over-year volume growth
for the Company.”
“Interpace
is uniquely positioned with our portfolio of testing services that offer physicians both confidence and convenience when determining
patient management strategies of surgery or surveillance,” said Rob Renjilian, Senior Vice President of Marketing. He added “Our
testing platform for indeterminate thyroid nodules provides very high NPV and PPV results. This allows physicians the ability to both
rule-in and rule-out thyroid cancer, while also offering the convenience of simple specimen handling because no vial refrigeration or
ice for shipping are needed.” Mr. Renjilian continued, “Splitting and sending specimens to different labs is not needed when
using Interpace’s testing services for pancreatic cyst fluid. With one specimen, we can run first-line fluid chemistry tests, such
as CEA and glucose, and also provide molecular testing when indicated. Our testing differentiates pancreatic cysts from high to low malignancy
potential with reliable clinical outcomes proven by up to 8 years of follow-up.”
Second
Quarter and 2024 Financial Performance
For
the Second Quarter of 2024 as Compared to the Second Quarter of 2023
|
● |
Net
Revenue was $12.0 million, an increase of 9% from $11.0 million for the prior-year quarter |
|
|
|
|
● |
Gross
Profit percentage was approximately 62% in both the current and prior-year quarters |
|
|
|
|
● |
Operating
income was $2.2 million vs $0.8 million in the prior-year quarter |
|
|
|
|
● |
Income
from continuing operations was $2.1 million vs $0.4 million in the prior-year quarter |
|
|
|
|
● |
Adjusted
EBITDA was $2.3 million vs $1.3 million in the prior-year quarter |
|
|
|
|
● |
Q2
2024 cash collections totaled $11.0 million, an increase of 7% from $10.2 million for the prior-year quarter |
|
|
|
|
● |
June
30, 2024 cash balance was $2.0 million vs June 30, 2023 cash balance of $5.1 million, driven by $4.6 million additional long-term
debt paydown |
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, 2023, 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 | | |
Six
Months Ended | |
| |
June
30, | | |
June
30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Revenue,
net | |
$ | 12,001 | | |
$ | 11,026 | | |
$ | 22,273 | | |
$ | 20,853 | |
Cost
of revenue | |
| 4,611 | | |
| 4,191 | | |
| 8,812 | | |
| 8,039 | |
Gross
Profit | |
| 7,390 | | |
| 6,835 | | |
| 13,461 | | |
| 12,814 | |
| |
| | | |
| | | |
| | | |
| | |
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
amortization expense | |
| - | | |
| 318 | | |
| - | | |
| 635 | |
Total
operating expenses | |
| 5,174 | | |
| 6,003 | | |
| 10,371 | | |
| 11,306 | |
| |
| | | |
| | | |
| | | |
| | |
Operating
income | |
| 2,216 | | |
| 832 | | |
| 3,090 | | |
| 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 | |
| 2,099 | | |
| 399 | | |
| 2,675 | | |
| 833 | |
Provision
for income taxes | |
| 4 | | |
| 4 | | |
| 8 | | |
| 8 | |
Income
from continuing operations | |
| 2,095 | | |
| 395 | | |
| 2,667 | | |
| 825 | |
| |
| | | |
| | | |
| | | |
| | |
Loss
from discontinued operations, net of tax | |
| (74 | ) | |
| (220 | ) | |
| (178 | ) | |
| (299 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net
income | |
$ | 2,021 | | |
$ | 175 | | |
$ | 2,489 | | |
$ | 526 | |
| |
| | | |
| | | |
| | | |
| | |
Basic
income (loss) per share of common stock: | |
| | | |
| | | |
| | | |
| | |
From
continuing operations | |
$ | 0.48 | | |
$ | 0.09 | | |
$ | 0.61 | | |
$ | 0.19 | |
From
discontinued operations | |
| (0.02 | ) | |
| (0.05 | ) | |
| (0.04 | ) | |
| (0.07 | ) |
Net
income per basic share of common stock | |
$ | 0.46 | | |
$ | 0.04 | | |
$ | 0.57 | | |
$ | 0.12 | |
| |
| | | |
| | | |
| | | |
| | |
Diluted
income (loss) per share of common stock: | |
| | | |
| | | |
| | | |
| | |
From
continuing operations | |
$ | 0.48 | | |
$ | 0.09 | | |
$ | 0.61 | | |
$ | 0.19 | |
From
discontinued operations | |
| (0.02 | ) | |
| (0.05 | ) | |
| (0.04 | ) | |
| (0.07 | ) |
Net
income per diluted share of common stock | |
$ | 0.46 | | |
$ | 0.04 | | |
$ | 0.57 | | |
$ | 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 | |
Selected
Balance Sheet Data (unaudited)
($
in thousands)
| |
June
30, | | |
December
31, | |
| |
2024 | | |
2023 | |
Cash and cash equivalents | |
$ | 2,019 | | |
$ | 3,498 | |
| |
| | | |
| | |
Total current assets | |
| 10,125 | | |
| 10,322 | |
Total current liabilities | |
| 19,030 | | |
| 17,474 | |
| |
| | | |
| | |
Total assets | |
| 12,931 | | |
| 13,021 | |
Total liabilities | |
| 25,462 | | |
| 28,157 | |
Total stockholders' deficit | |
| (59,067 | ) | |
| (61,672 | ) |
Selected
Cash Flow Data (Unaudited)
($
in thousands)
| |
For the Six
Months Ended | |
| |
June
30, | |
| |
2024 | | |
2023 | |
Net income | |
$ | 2,489 | | |
$ | 526 | |
| |
| | | |
| | |
Net cash provided by operating activities | |
$ | 1,346 | | |
$ | 1,544 | |
Net cash used in investing activities | |
| (225 | ) | |
| (293 | ) |
Net cash used in financing
activities | |
| (2,600 | ) | |
| (1,000 | ) |
Change in cash and cash equivalents | |
| (1,479 | ) | |
| 251 | |
Cash and cash equivalents
– beginning | |
| 3,498 | | |
| 4,828 | |
Cash and cash equivalents
– ending | |
$ | 2,019 | | |
$ | 5,079 | |
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) | |
$ | 2,095 | | |
$ | 395 | | |
$ | 2,667 | | |
$ | 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 | |
$ | 2,336 | | |
$ | 1,324 | | |
$ | 3,341 | | |
$ | 2,544 | |
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 and contingent consideration. The table above includes a reconciliation of this non-GAAP financial measure to the most
directly comparable GAAP financial measure.
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Interpace Biosciences (QX) (USOTC:IDXG)
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