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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 14, 2024
INVO
BIOSCIENCE, INC.
(Exact
name of registrant as specified in its charter)
Nevada |
|
001-39701 |
|
20-4036208 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(I.R.S.
Employer
Identification
No.) |
5582
Broadcast Court
Sarasota,
FL 34240
(Address
of principal executive offices, including zip code)
(978)
878-9505
(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 |
Common
Stock, $0.0001 par value |
|
INVO |
|
The
Nasdaq Stock Market LLC |
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 14, 2024, INVO Bioscience, Inc. (the “Company”) issued a press release announcing financial results for the period
ended June 30, 2024. The text of the press release is furnished as Exhibit 99.1 to this current report.
The
information in this Item 2.02 and Exhibit 99.1 hereto shall not be deemed “filed” for the purposes of or otherwise subject
to the liabilities under Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Unless expressly
incorporated into a filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, the information contained
in this Item 2.02 and Exhibit 99.1 hereto shall not be incorporated by reference into any Company filing, whether made before or after
the date hereof, regardless of any general incorporation language in such filing.
Item
9.01. Financial Statements and Exhibits.
(d)
Exhibits
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 hereunto duly authorized.
Date:
August 14, 2024 |
INVO
BIOSCIENCE, INC. |
|
|
|
/s/ Steven Shum |
|
Steven
Shum |
|
Chief
Executive Officer |
Exhibit
99.1
INVO
Reports Record Second Quarter 2024 Financial Results with 481% Revenue Growth and a $1.1 Million Improvement to Adjusted EBITDA
SARASOTA,
Fla., August 14, 2024 — INVO Bioscience, Inc. (Nasdaq: INVO) (“INVO” or the “Company”), a healthcare services
fertility company focused on expanding access to advanced treatment through the establishment and acquisition of fertility clinics, and
with the intravaginal culture (“IVC”) procedure enabled by its INVOcell® medical device, today announced financial
results for the second quarter 2024 for the period ended June 30, 2024 and provided a business update.
Q2
2024 Financial Highlights (all metrics compared to Q2 2023 unless otherwise noted)
|
● |
Revenue
was $1,836,597, an increase of 481% compared to $315,902. Revenue increased 17% sequentially compared to Q1 2024. |
|
● |
Clinic
revenue increased 611% to $1,807,921, compared to $254,364. All reported clinic revenue is derived from the Company’s INVO
Center in Atlanta, Georgia, and its fertility clinic in Middleton, Wisconsin, both of which are consolidated in the Company’s
financial statements. |
|
● |
Revenue
from all clinics, inclusive of both those accounted for as consolidated and under the equity method, was $2,141,229, an increase
of 201% compared to $712,433. |
|
● |
Total
operating expenses were $3.7 million, a $1.3 million increase compared to $2.4 million. The increase was primarily due to a one-time
non-cash expense of $1.0 million and a $0.2 million increase in amortization costs. Q2 2024 operating expenses also included approximately
$25,000 pertaining to the proposed merger with NAYA Biosciences, Inc. (“NAYA”). |
|
● |
Net
loss was $(2.2) million compared to $(2.2) million. |
|
● |
Adjusted
EBITDA (see table included) was $(0.5) million, including approximately $25,000 in transaction costs related to the potential merger,
compared to $(1.6) million in the prior year. |
Management
Commentary
“The
growing, positive impact of our acquisition strategy remains in full swing as we report record second quarter revenue – up 481%
year-over-year and 17% sequentially – with a $1.1 million improvement in adjusted EBITDA,” commented Steve Shum, CEO of INVO.
“Our fertility centers in Middleton, Atlanta, and Birmingham are all experiencing sequential revenue growth and are collectively
profitable. This growth and clinic-level profit, coupled with our careful management of overall corporate expenses, positions us to achieve
our stated goal of reaching breakeven with our current operations. To accelerate our path to profitability, we also expect to resume
both our acquisition and new INVO Center activities in 2025. I look forward to the continued strong execution by our team and making
fertility care more accessible and inclusive to people in need.”
Definitive
Merger Agreement
As
originally reported, on October 23, 2023, INVO and NAYA, a company dedicated to increasing patient access to breakthrough treatments
in oncology and regenerative medicine, jointly announced that they had entered into a definitive merger agreement (the “Merger
Agreement”) for INVO to acquire NAYA in an all-stock transaction. The Merger Agreement was subsequently amended three times to
primarily extend the target closing date and interim funding requirements to be provided by NAYA. INVO and NAYA are currently in discussions
to agree to a further extension.
Financial
Tables
Included
in this press release is a reconciliation of Adjusted EBITDA. All additional financial tables are included in the Company’s 10-Q,
which can be found on the Company’s website at https://www.invobioscience.com/sec-filings/ or at https://www.sec.gov/.
Use
of Non-GAAP Measure
Adjusted
EBITDA is a non-GAAP measure. This measure is not intended to be a substitute for those financial measures reported in accordance with
GAAP. Adjusted EBITDA has been included because management believes that, when considered together with the GAAP figures, it provides
meaningful information related to our operating performance and liquidity and can enhance an overall understanding of financial results
and trends. Adjusted EBITDA may be calculated by us differently than other companies that disclose measures with the same or similar
terms. See our attached financials for a reconciliation of this non-GAAP measure to the nearest GAAP measure.
About
INVO Bioscience
We
are a healthcare services fertility company dedicated to expanding the assisted reproductive technology (“ART”) marketplace
by making fertility care accessible and inclusive to people around the world. Our commercialization strategy is focused on the opening
of dedicated “INVO Centers” offering the INVOcell® and IVC procedure (with three centers in North America
now operational), the acquisition of US-based, profitable in vitro fertilization (“IVF”) clinics and the sale and distribution
of our technology solution into existing fertility clinics. Our proprietary technology, INVOcell®, is a revolutionary
medical device that allows fertilization and early embryo development to take place in vivo within the woman’s body. This treatment
solution is the world’s first intravaginal culture technique for the incubation of oocytes and sperm during fertilization and early
embryo development. This technique, designated as “IVC”, provides patients a more natural, intimate, and more affordable
experience in comparison to other ART treatments. We believe the IVC procedure can deliver comparable results at a fraction of the cost
of traditional IVF and is a significantly more effective treatment than intrauterine insemination (“IUI”). For more information,
please visit www.invobio.com.
Safe
Harbor Statement
This
release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended. The Company invokes the protections of the Private Securities Litigation Reform
Act of 1995. All statements regarding our expected future financial position, results of operations, cash flows, financing plans, business
strategies, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations,
as well as statements that include words such as “anticipate,” “if,” “believe,” “plan,”
“estimate,” “expect,” “intend,” “may,” “could,” “should,” “will,”
and other similar expressions are forward-looking statements. All forward-looking statements involve risks, uncertainties, and contingencies,
many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated
results, performance, or achievements. Factors that may cause actual results to differ materially from those in the forward-looking statements
include those set forth in our filings at www.sec.gov. We are under no obligation to (and expressly disclaim any such obligation
to) update or alter our forward-looking statements, whether as a result of new information, future events, or otherwise.
CONTACT
INVO
Bioscience:
Steve
Shum
978-878-9505
sshum@invobio.com
INVO
Investor Contact:
Robert
Blum (Lytham Partners, LLC)
602-889-9700
INVO@lythampartners.com
Adjusted
EBITDA
| |
Three Months Ended | |
| |
June 30 | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Net loss attributable to INVO Bioscience, Inc. | |
$ | (2,245,170 | ) | |
$ | (2,240,511 | ) |
Interest expense | |
| 118,640 | | |
| 52,474 | |
Amortization of debt discount | |
| 250,972 | | |
| 122,718 | |
Stock-based compensation | |
| 1,031,071 | | |
| 99,338 | |
Stock option expense | |
| 69,035 | | |
| 326,916 | |
Non cash compensation for services | |
| 45,000 | | |
| 45,000 | |
Foreign currency exchange loss | |
| - | | |
| 265 | |
(Gain) loss on disposal of fixed assets | |
| (50,000 | ) | |
| - | |
Loss from debt extinguishment | |
| 40,491 | | |
| - | |
Depreciation and amortization | |
| 230,338 | | |
| 19,705 | |
Adjusted EBITDA | |
$ | (509,623 | ) | |
$ | (1,574,095 | ) |
| |
| | | |
| | |
Proforma net loss | |
$ | (2,245,170 | ) | |
$ | (2,041,621 | ) |
Interest expense | |
| 118,640 | | |
| 52,474 | |
Amortization of debt discount | |
| 250,972 | | |
| 122,718 | |
Stock-based compensation | |
| 1,031,071 | | |
| 99,338 | |
Stock option expense | |
| 69,035 | | |
| 326,916 | |
Non-cash compensation for services | |
| 45,000 | | |
| 45,000 | |
Foreign currency exchange loss | |
| - | | |
| 265 | |
(Gain) loss on disposal of fixed assets | |
| (50,000 | ) | |
| - | |
Loss from debt extinguishment | |
| 40,491 | | |
| - | |
Depreciation and amortization | |
| 230,338 | | |
| 19,705 | |
Proforma adjusted EBITDA | |
$ | (509,623 | ) | |
$ | (1,375,205 | ) |
INVO
BIOSCIENCE, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
| |
For the Three Months Ended June 30, | | |
For the Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Revenue: | |
| | | |
| | | |
| | | |
| | |
Clinic revenue | |
$ | 1,807,921 | | |
$ | 254,364 | | |
$ | 3,345,120 | | |
$ | 551,745 | |
Product revenue | |
| 28,676 | | |
| 61,538 | | |
| 67,763 | | |
| 112,182 | |
Total revenue | |
| 1,836,597 | | |
| 315,902 | | |
| 3,412,883 | | |
| 663,927 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Cost of revenue | |
| 861,648 | | |
| 235,714 | | |
| 1,711,882 | | |
| 466,719 | |
Selling, general and administrative | |
| 2,647,524 | | |
| 2,042,609 | | |
| 4,088,110 | | |
| 4,373,443 | |
Research and development | |
| - | | |
| 83,850 | | |
| 4,880 | | |
| 157,370 | |
Depreciation and amortization | |
| 230,338 | | |
| 19,705 | | |
| 457,298 | | |
| 38,792 | |
Total operating expenses | |
| 3,739,510 | | |
| 2,381,879 | | |
| 6,262,170 | | |
| 5,036,324 | |
Loss from operations | |
| (1,902,913 | ) | |
| (2,065,977 | ) | |
| (2,849,287 | ) | |
| (4,372,397 | ) |
Other income (expense): | |
| | | |
| | | |
| | | |
| | |
Gain (loss) from equity method investment | |
| 17,846 | | |
| 3,788 | | |
| 17,950 | | |
| (23,947 | ) |
Gain (loss) on disposal of fixed assets | |
| 50,000 | | |
| - | | |
| (511,663 | ) | |
| - | |
Gain on lease termination | |
| - | | |
| - | | |
| 94,551 | | |
| - | |
Loss from debt extinguishment | |
| (40,491 | ) | |
| - | | |
| (40,491 | ) | |
| - | |
Interest expense | |
| (369,612 | ) | |
| (175,192 | ) | |
| (550,907 | ) | |
| (391,781 | ) |
Foreign currency exchange loss | |
| - | | |
| (265 | ) | |
| - | | |
| (400 | ) |
Total other income (expense) | |
| (342,257 | ) | |
| (171,669 | ) | |
| (990,560 | ) | |
| (416,128 | ) |
Loss before income taxes | |
| (2,245,170 | ) | |
| (2,237,646 | ) | |
| (3,839,847 | ) | |
| (4,788,525 | ) |
Income taxes | |
| - | | |
| 2,865 | | |
| 1,836 | | |
| 2,865 | |
Net loss | |
$ | (2,245,170 | ) | |
$ | (2,240,511 | ) | |
$ | (3,841,683 | ) | |
$ | (4,791,390 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per common share: | |
| | | |
| | | |
| | | |
| | |
Basic | |
$ | (0.62 | ) | |
$ | (3.06 | ) | |
$ | (1.25 | ) | |
$ | (7.07 | ) |
Diluted | |
$ | (0.62 | ) | |
$ | (3.06 | ) | |
$ | (1.25 | ) | |
$ | (7.07 | ) |
Weighted average number of common shares outstanding: | |
| | | |
| | | |
| | | |
| | |
Basic | |
| 3,609,812 | | |
| 732,255 | | |
| 3,072,877 | | |
| 677,684 | |
Diluted | |
| 3,609,812 | | |
| 732,255 | | |
| 3,072,877 | | |
| 677,684 | |
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