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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 13, 2023
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
November 13, 2023, INVO Bioscience, Inc. (the “Company”) issued a press release announcing financial results for the period
ended September 30, 2023. 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:
November 13, 2023 |
INVO
BIOSCIENCE, INC. |
|
|
|
/s/
Steven Shum |
|
Steven
Shum |
|
Chief
Executive Officer |
Exhibit
99.1
INVO
Reports Record Third Quarter 2023 Financial Results
Company
Expects to Host Conference Call Shortly After November 20, 2023 Following the Progress of Certain Closing Conditions Pertaining to the
Announced Merger Agreement with NAYA Biosciences
SARASOTA,
Fla., Nov. 13, 2023 /PRNewswire/ — INVO Bioscience, Inc. (Nasdaq: INVO) (“INVO” or the “Company”), a healthcare
services fertility company focused on expanding access to advanced treatment worldwide with its INVOcell® medical device and the
intravaginal culture (“IVC”) procedure it enables, today announced financial results for the third quarter ended September
30, 2023 and provided a business update.
Q3
2023 Financial Highlights (all metrics compared to Q3 2022 unless otherwise noted)
|
● |
Revenues
of $974,894 increased 314% compared to $235,321. |
|
|
|
|
● |
Q3
2023 included only a partial quarter contribution from the recently acquired Wisconsin Fertility Institute (WFI). Pro forma revenue
for Q3 2023, assuming a full quarter of WFI, would have been approximately $1.5 million. |
|
|
|
|
● |
Adjusted
EBITDA was $(0.6) million compared to $(2.0) million. Pro forma adjusted EBITDA, assuming a full quarter contribution from WFI, would
have been $(0.3) million and the Company is on a progression towards positive earnings and operating cashflows. |
|
|
|
|
● |
Clinic
revenue increased 437% to $947,891, compared to $176,395. All reported clinic revenue is derived from the Company’s INVO Centers
in Atlanta, Georgia, and WFI (partial quarter) 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 $1,352,881, an increase
of 169% compared to $502,993. |
|
|
|
|
● |
Total
operating costs were approximately $1.9 million, a $0.9 million decrease compared to $2.8 million. |
|
|
|
|
● |
Net
loss was $(1.2) million compared to $(2.5) million. Pro forma net loss, assuming a full quarter contribution from WFI, would have
been $(1.0) million. |
|
|
|
|
● |
Exclusive
of corporate overhead, the clinics generated positive net income in the period. |
Recent
Operational and Strategic Highlights
|
● |
On
August 10, 2023, INVO acquired WFI, a profitable Madison-based fertility center. |
|
|
|
|
● |
Implemented
certain corporate expense reductions as part of go-forward plan to focus on its healthcare service strategy and a near-term path
to profitability. |
|
|
|
|
● |
On
October 23, 2023, INVO and NAYA Biosciences Inc., 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 for INVO to acquire
NAYA Biosciences, Inc. (“NAYA”) in an all-stock transaction. |
Management
Commentary
“The
results of the quarter highlight the transformation of INVO into a growing, innovative healthcare services company leveraging our INVO
Centers to drive IVC volume and obtain a greater share of the total fertility cycle revenue,” commented Steve Shum, CEO of INVO.
“When you look at the pro forma results for the quarter inclusive of a full quarter contribution from WFI our adjusted EBITDA would
have been $(0.3) million, a significant improvement compared to ($2.0) million in the year ago quarter. Equally notable was the fact
that our clinics, exclusive of our corporate costs, generated positive net income in the period. With the potential for continued growth
from our family of INVO Centers, and more rationalized corporate operating expenses, achieving our stated goal of profitability in 2024
becomes increasingly visible. We look forward to maintaining our focus on driving growth and efficiencies in the business moving forward.”
Definitive
Merger Agreement
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”)
for INVO to acquire NAYA Biosciences in an all-stock transaction. Under the terms of the agreement, NAYA Biosciences’ shareholders
will receive 7.3333 shares of INVO for each share of NAYA Biosciences at closing, for a total of approximately 18,150,000 shares of INVO.
Following the closing of the Merger, the combined company is expected to operate under the name “NAYA Biosciences”.
As
described in greater detail in the Company’s SEC filings and press releases, the Merger remains subject to certain closing conditions
including shareholder approval, an estimated $5 million or more (at NAYA’s discretion) in interim private financing in INVO at
a premium of INVO’s market price at time of financing (“Interim PIPE”), and a private offering by the combined company
at a target price of $5.00 per common share of INVO. At this time, there are no further updates on the satisfaction of the closing conditions.
“We
are excited by the opportunity to merge INVO and NAYA and having the financial resources to advance both the fertility and newly acquired
oncology operations,” commented Shum. “We believe this combination provides the benefit of bringing our existing, revenue-generating
operations from our fertility business with an ability to further grow these activities, along with the significant upside potential
of innovative cancer therapeutics.”
Financial
Results
Only
partial quarter results from WFI, which INVO acquired on August 10, 2023, are included in the results for the
three months ended September 30, 2023. Where applicable, pro forma results are provided as if the acquisition closed on July 1, 2023
and therefore would have been included for the entire quarter.
Revenue
for the three months ended September 30, 2023, was $974,894 compared to $235,321 for the three months ended September 30, 2023, an increase
of 314%. Pro forma revenue for Q3 2023, assuming a full quarter of WFI, would have been $1,492,520, an increase of 534%.
Clinic
revenue from the Company’s consolidated INVO Centers was $947,891 during the third quarter of 2023, an increase of 437% compared
to $176,395 for the three months ended September 30, 2022. Revenue from all INVO Centers combined was $1,352,881, an increase of 201%
compared to the year-ago period.
Selling,
general and administrative expenses for the three months ended September 30, 2023, were approximately $1.3 million compared to approximately
$2.3 million for the three months ended September 30, 2022. The decrease of approximately $1.0 million, or approximately 46%, was primarily
the result of approximately $1.1 million in decreased personnel expenses and approximately $0.2 million in decreased marketing expenses,
and was partially offset by a $0.1 million increase in professional fees and a $0.1 million increase in operational expenses related
to WFI.
R&D
expenses were approximately $0.0 million and $0.2 million for the three months ended September 30, 2023, and September 30, 2022, respectively.
The decrease is a result of the Company receiving FDA clearance in June 2023 for its 510(k) application.
Total
operating costs were $1.9 million and $2. 8 million for the three months ended September 30, 2023, and September 30, 2022, respectively.
Net
loss was $(1.2) million and $(2.5) million for the three months ended September 30, 2023, and September 30, 2022, respectively. Pro forma
net loss, assuming a full quarter contribution from WFI, would have been approximately $(1.0) million.
Adjusted
EBITDA (see Adjusted EBITDA Table) for the three months ended September 30, 2023, was $(0.6) million, compared to adjusted EBITDA of
$(2.0) million for the quarter ended September 30, 2022. Pro forma adjusted EBITDA, assuming a full quarter contribution from WFI, would
have been approximately $(0.3) million.
As
of September 30, 2023, the Company had approximately $1.1 million in cash.
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.
Conference
Call Details
INVO
will announce details for a conference call in a future press release. The conference call is expected to be held after November 20,
2023, and following the progress of certain closing conditions pertaining to the Merger.
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
INVO BIOSCIENCE, INC.
CONSOLIDATED BALANCE SHEETS
| |
June 30, 2023 | | |
December 31, 2022 | |
| |
| | |
| |
ASSETS | |
| | | |
| | |
Current assets | |
| | | |
| | |
Cash | |
$ | 1,055,544 | | |
$ | 90,135 | |
Accounts receivable | |
| 116,781 | | |
| 77,149 | |
Inventory | |
| 254,220 | | |
| 263,602 | |
Prepaid expenses and other current assets | |
| 365,227 | | |
| 190,201 | |
Total current assets | |
| 1,791,772 | | |
| 621,087 | |
Property and equipment, net | |
| 772,447 | | |
| 436,729 | |
Lease right of use | |
| 5,858,042 | | |
| 1,808,034 | |
Intangible assets | |
| 1,750,000 | | |
| - | |
Goodwill | |
| 8,224,708 | | |
| - | |
Investment in joint ventures | |
| 1,079,202 | | |
| 1,237,865 | |
Total assets | |
$ | 19,476,171 | | |
$ | 4,103,715 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Accounts payable and accrued liabilities | |
$ | 1,851,783 | | |
$ | 1,349,038 | |
Accrued compensation | |
| 590,598 | | |
| 946,262 | |
Notes payable, current portion | |
| 822,574 | | |
| 100,000 | |
Notes payable, related party | |
| 880,000 | | |
| 662,644 | |
Deferred revenue | |
| 229,921 | | |
| 119,876 | |
Lease liability, current portion | |
| 385,836 | | |
| 231,604 | |
Other current liabilities | |
| 123,432 | | |
| - | |
Total current liabilities | |
| 4,884,144 | | |
| 3,409,424 | |
Notes payable, net of current portion | |
| 1,095,000 | | |
| - | |
Lease liability, net of current portion | |
| 5,622,279 | | |
| 1,669,954 | |
Deferred tax liability | |
| 1,949 | | |
| 1,949 | |
Additional payments for acquisition | |
| 7,500,000 | | |
| - | |
Total liabilities | |
| 19,103,372 | | |
| 5,081,327 | |
| |
| | | |
| | |
Stockholders’ equity (deficit) | |
| | | |
| | |
Common Stock, $.0001 par value; 50,000,000 shares authorized; 2,474,756 and 608,611 issued and
outstanding as of September 30, 2023 and December 31, 2022, respectively | |
| 247 | | |
| 61 | |
Additional paid-in capital | |
| 56,195,915 | | |
| 48,805,860 | |
Accumulated deficit | |
| (55,823,363 | ) | |
| (49,783,533 | ) |
Total stockholders’ equity (deficit) | |
| 372,799 | | |
| (977,612 | ) |
| |
| - | | |
| | |
Total liabilities and stockholders’ equity (deficit) | |
$ | 19,476,171 | | |
$ | 4,103,715 | |
INVO BIOSCIENCE, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
| |
For the Three Months Ended September 30, | | |
For the Nine Months Ended September 30, | |
| |
| 2023 | | |
| 2022 | | |
| 2023 | | |
| 2022 | |
Revenue: | |
| | | |
| | | |
| | | |
| | |
Clinic revenue | |
$ | 947,891 | | |
$ | 176,395 | | |
$ | 1,499,636 | | |
$ | 394,601 | |
Product revenue | |
| 27,003 | | |
| 58,926 | | |
| 139,185 | | |
| 149,453 | |
Total revenue | |
| 974,894 | | |
| 235,321 | | |
| 1,638,821 | | |
| 544,054 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Cost of revenue | |
| 580,968 | | |
| 248,977 | | |
| 1,047,687 | | |
| 616,184 | |
Selling, general and administrative | |
| 1,257,044 | | |
| 2,316,763 | | |
| 5,630,487 | | |
| 7,308,478 | |
Research and development | |
| 2,668 | | |
| 175,267 | | |
| 160,038 | | |
| 470,208 | |
Depreciation and amortization | |
| 20,504 | | |
| 19,732 | | |
| 59,296 | | |
| 57,361 | |
Total operating expenses | |
| 1,861,184 | | |
| 2,760,739 | | |
| 6,897,508 | | |
| 8,452,231 | |
Loss from operations | |
| (886,290 | ) | |
| (2,525,418 | ) | |
| (5,258,687 | ) | |
| (7,908,177 | ) |
Other income (expense): | |
| | | |
| | | |
| | | |
| | |
Gain (loss) from equity method joint ventures | |
| (8,163 | ) | |
| (21,470 | ) | |
| (32,110 | ) | |
| (210,565 | ) |
Interest income | |
| - | | |
| 34 | | |
| - | | |
| 307 | |
Interest expense | |
| (352,085 | ) | |
| (1,761 | ) | |
| (743,866 | ) | |
| (3,319 | ) |
Foreign currency exchange loss | |
| (16 | ) | |
| (1,008 | ) | |
| (416 | ) | |
| (2,922 | ) |
Total other income (expense) | |
| (360,264 | ) | |
| (24,205 | ) | |
| (776,392 | ) | |
| (216,499 | ) |
Loss before income taxes | |
| (1,246,554 | ) | |
| (2,549,623 | ) | |
| (6,035,079 | ) | |
| (8,124,676 | ) |
Income taxes | |
| 1,886 | | |
| - | | |
| 4,751 | | |
| 800 | |
Net loss | |
$ | (1,248,440 | ) | |
| (2,549,623 | ) | |
| (6,039,830 | ) | |
| (8,125,476 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per common share: | |
| | | |
| | | |
| | | |
| | |
Basic | |
$ | (0.70 | ) | |
$ | (4.19 | ) | |
$ | (5.76 | ) | |
$ | (13.42 | ) |
Diluted | |
$ | (0.70 | ) | |
$ | (4.19 | ) | |
$ | (5.76 | ) | |
$ | (13.42 | ) |
Weighted average number of common shares outstanding: | |
| | | |
| | | |
| | | |
| | |
Basic | |
| 1,776,898 | | |
| 607,783 | | |
| 1,048,115 | | |
| 605,356 | |
Diluted | |
| 1,776,898 | | |
| 607,783 | | |
| 1,048,115 | | |
| 605,356 | |
ADJUSTED EBITDA
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30 | | |
September 30 | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Net loss | |
$ | (1,248,440 | ) | |
$ | (2,549,623 | ) | |
$ | (6,039,830 | ) | |
$ | (8,125,476 | ) |
Interest expense | |
| 40,924 | | |
| 1,727 | | |
| 131,607 | | |
| 3,012 | |
Foreign currency exchange loss | |
| 16 | | |
| 1,008 | | |
| 416 | | |
| 2,922 | |
Stock-based compensation | |
| 13,918 | | |
| 79,479 | | |
| 309,659 | | |
| 524,793 | |
Stock option expense | |
| 251,555 | | |
| 426,143 | | |
| 904,305 | | |
| 1,287,427 | |
Non-cash compensation for services | |
| 45,000 | | |
| 45,000 | | |
| 135,000 | | |
| 75,000 | |
Amortization of debt discount | |
| 311,161 | | |
| - | | |
| 612,259 | | |
| - | |
Depreciation and amortization | |
| 20,504 | | |
| 19,732 | | |
| 59,296 | | |
| 57,361 | |
Adjusted EBITDA | |
$ | (565,362 | ) | |
$ | (1,976,534 | ) | |
$ | (3,887,288 | ) | |
$ | (6,174,961 | ) |
| |
| | | |
| | | |
| | | |
| | |
Proforma net loss | |
$ | (998,380 | ) | |
$ | (2,057,245 | ) | |
$ | (5,128,430 | ) | |
$ | (9,571,686 | ) |
Interest expense | |
| 40,924 | | |
| 1,727 | | |
| 131,607 | | |
| 3,012 | |
Foreign currency exchange loss | |
| 16 | | |
| 1,008 | | |
| 416 | | |
| 2,922 | |
Stock-based compensation | |
| 13,918 | | |
| 79,479 | | |
| 309,659 | | |
| 524,793 | |
Stock option expense | |
| 251,555 | | |
| 426,143 | | |
| 904,305 | | |
| 1,287,427 | |
Non-cash compensation for services | |
| 45,000 | | |
| 45,000 | | |
| 135,000 | | |
| 75,000 | |
Amortization of debt discount | |
| 311,161 | | |
| - | | |
| 612,259 | | |
| - | |
Depreciation and amortization | |
| 20,504 | | |
| 19,732 | | |
| 59,296 | | |
| 57,361 | |
Proforma adjusted EBITDA | |
$ | (315,302 | ) | |
$ | (1,484,156 | ) | |
$ | (2,975,888 | ) | |
$ | (7,621,171 | ) |
INVO
Center RESULTS
The following tables summarize the combined financial information of our consolidated and equity method joint venture INVO Centers:
| |
For the Three Months Ended September 30, | | |
For the Nine Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Statements of operations: | |
| | | |
| | | |
| | | |
| | |
Operating revenue | |
$ | 1,352,881 | | |
$ | 502,993 | | |
$ | 2,712,021 | | |
$ | 1,170,378 | |
Operating expenses | |
| (1,231,274 | ) | |
| (721,663 | ) | |
| (2,745,932 | ) | |
| (2,123,480 | ) |
Net income | |
$ | 121,607 | | |
$ | (218,670 | ) | |
$ | (33,911 | ) | |
$ | (953,102 | ) |
| |
September 30, 2023 | | |
December 31, 2022 | |
Balance sheets: | |
| | | |
| | |
Current assets | |
$ | 577,496 | | |
$ | 447,422 | |
Long-term assets | |
| 3,780,410 | | |
| 2,000,841 | |
Current liabilities | |
| (1,158,194 | ) | |
| (735,767 | ) |
Long-term liabilities | |
| (2,777,250 | ) | |
| (1,042,167 | ) |
Net assets | |
$ | 422,462 | | |
$ | 670,329 | |
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Grafico Azioni INVO BioScience (NASDAQ:INVO)
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