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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, 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
August 14, 2023, INVO Bioscience, Inc. (the “Company”) issued a press release announcing financial results for the period
ended June 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:
August 14, 2023 |
INVO
BIOSCIENCE, INC. |
|
|
|
/s/
Steven Shum |
|
Steven
Shum |
|
Chief
Executive Officer |
Exhibit
99.1
INVO
Reports Second Quarter 2023 Financial Results
Company
to Host Conference Call Today at 4:30pm ET
SARASOTA,
Fla., August 14, 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 second quarter ended
June 30, 2023 and provided a business update.
Q2
2023 Financial Highlights (all metrics compared to Q2 2022 unless otherwise noted)
|
● |
Revenue
was $315,902, an increase of 116% compared to $146,135. |
|
● |
Clinic
revenue increased 126% to $254,364, compared to $112,358. All reported clinic revenue is derived from the Company’s INVO Center
in Atlanta, Georgia, which is 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 $712,433, an increase of
145% compared to $290,517. |
Recent
Operational and Strategic Highlights
|
● |
Acquired
Wisconsin Fertility Institute (WFI), a profitable Madison-based fertility center that primarily offers conventional IVF procedures
and generated approximately $5.4 million in revenue and approximately $1.7 million of net income in 2022. |
|
● |
Acquisition
further accelerates INVO’s transition to a healthcare services company and provides an opportunity to advance IVC volume and
the ability to secure a greater share of total fertility cycle revenue. |
|
● |
Implemented
expense reductions as part of go-forward plan to focus on its healthcare service strategy and a near-term path to profitability. |
|
● |
Buildout
of the Company’s new Tampa, Florida clinic – Tampa Fertility Institute, an INVO Center – is nearing completion. |
|
● |
Raised
approximately $4.5 million in gross proceeds in a public offering of common stock and warrants. The Company used approximately $2.15
million of proceeds for the initial payment for the WFI acquisition. |
|
● |
Received
510(k) FDA clearance for expanded use of the INVOcell device. |
Management
Commentary
“We
believe we have successfully transformed INVO into a rapidly growing, innovative healthcare services company which allows us to help
accelerate IVC volume and obtain a greater share of the total fertility cycle revenue,” commented Steve Shum, CEO of INVO. “The
closing of the WFI acquisition last week, coupled with the rapid 145% revenue growth in our existing INVO Center’s during this
past quarter, should position our clinic operations to be cash flow positive in the third quarter of this year. Further, we have
implemented a number of expense reductions as part of our go-forward plan to focus on our healthcare service strategy, which when coupled
with the elimination of substantive costs associated with our successful 510(k) submission, should drive the business towards overall
operating cash flow positive in 2024.”
Acquisition
Details
On
August 11, 2023, INVO announced it closed the acquisition of Wisconsin Fertility Institute, one of the state’s
leading fertility centers, having assisted in welcoming over 5,000 babies since opening its doors in 2007 and completing approximately
550 conventional IVF cycles in 2022. The acquisition provides operational scale and complements the Company’s new-build INVO Center
strategy. The Madison-based fertility center primarily offers conventional IVF procedures, having generated approximately $5.4 million
in revenue and net income of approximately $1.7 million for the year ended December 31, 2022. INVO will look to further expand the center
through the introduction of the IVC procedure as an added service offered to patients.
The
purchase price of the acquisition is $10 million payable over a three-year period. There was an initial $2.15 million cash payment made
at closing (net of a $350,000 holdback), with subsequent $2.5 million payments due annually for the following three years. At the discretion
of the sellers, subsequent payments may be paid in cash or in a fixed amount of shares of INVO common stock at presently agreed values.
Wisconsin Fertility Institute becomes a wholly owned subsidiary, and its financial statements will be consolidated with those of INVO.
Financial
Results
Revenue
for the three months ended June 30, 2023, was $315,902 compared to $146,135 for the three months ended June 30, 2022, an increase of
116%
Clinic
revenue from the Company’s consolidated INVO Center was $254,364 during the second quarter of 2023, an increase of 126% compared
to $112,358 for the three months ended June 30, 2022. Revenue from all INVO Centers combined was $712,433, an increase of 145% compared
to the year-ago period.
Selling,
general and administrative expenses for the three months ended June 30, 2023, were approximately $2.0 million compared to approximately
$2.4 million for the three months ended June 30, 2022. The decrease of approximately $0.4 million was primarily the result of approximately
$0.2 million in decreased personnel expenses and approximately $0.2 million in decreased marketing expenses. Non-cash, stock-based compensation
expense, which was $0.4 million in the period, compared to $0.7 million for the same period in the prior year.
R&D
expenses were approximately $0.1 million and $0.2 million for the three months ended June 30, 2023, and June 30, 2022, respectively.
Gain
from equity investments for the three months ended June 30, 2023, was approximately $4,000 compared to a $0.1 million loss for the three
months ended June 30, 2022. The gain is due to an increase in revenue from the equity method JV’s and a decrease in expenses associated
with one-time startup costs.
Adjusted
EBITDA (see Adjusted EBITDA Table) for the three months ended June 30, 2023, was $(1.6) million, compared to adjusted EBITDA of $(2.2)
million for the quarter ended June 30, 2022.
As
of June 30, 2023, the Company had approximately $0.1 million in cash. Subsequent to the end of the quarter, the company completed a public
offering generating $4.5 million in gross proceeds.
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
has scheduled a conference call for Monday, August 14, 2023, at 4:30 pm ET (1:30 pm PT) to review these results and recent events. Interested
parties can access the conference call by dialing (833) 756-0861 or (412) 317-5751, or can listen via a live Internet webcast at https://app.webinar.net/y0l43MO6o9Z,
or via the Investor Relations section of the Company’s website at https://www.invobio.com/investors. A teleconference replay
of the call will be available through August 21, 2023, at (877) 344-7529 or (412) 317-0088, confirmation #8863258. A webcast replay will
be available in the Investor Relations section of the Company’s website at https://www.invobio.com/investors for 90 days.
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.
INVO
BIOSCIENCE, INC.
CONSOLIDATED
BALANCE SHEETS
| |
June 30, 2023 | | |
December 31, 2022 | |
| |
| | |
| |
ASSETS | |
| | | |
| | |
Current assets | |
| | | |
| | |
Cash | |
$ | 112,485 | | |
$ | 90,135 | |
Accounts receivable | |
| 74,908 | | |
| 77,149 | |
Inventory | |
| 280,018 | | |
| 263,602 | |
Prepaid expenses and other current assets | |
| 374,714 | | |
| 190,201 | |
Total current assets | |
| 842,125 | | |
| 621,087 | |
Property and equipment, net | |
| 659,442 | | |
| 436,729 | |
Lease right of use | |
| 4,004,962 | | |
| 1,808,034 | |
Investment in joint ventures | |
| 1,132,365 | | |
| 1,237,865 | |
Total assets | |
$ | 6,638,894 | | |
$ | 4,103,715 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Accounts payable and accrued liabilities | |
$ | 1,844,629 | | |
$ | 1,349,038 | |
Accrued compensation | |
| 1,202,420 | | |
| 946,262 | |
Notes payable, net | |
| 263,888 | | |
| 100,000 | |
Notes payable - related parties, net | |
| 770,000 | | |
| 662,644 | |
Deferred revenue | |
| 161,187 | | |
| 119,876 | |
Lease liability, current portion | |
| 227,026 | | |
| 231,604 | |
Total current liabilities | |
| 4,469,150 | | |
| 3,409,424 | |
Lease liability, net of current portion | |
| 3,873,289 | | |
| 1,669,954 | |
Deferred tax liability | |
| 1,949 | | |
| 1,949 | |
Total liabilities | |
| 8,344,388 | | |
| 5,081,327 | |
| |
| | | |
| | |
Stockholders’ equity (deficit) | |
| | | |
| | |
Common Stock, $.0001 par value; 6,250,000 shares authorized; 826,886 and 608,611 issued and outstanding as of June 30, 2023 and December 31, 2022, respectively | |
| 83 | | |
| 61 | |
Additional paid-in capital | |
| 52,869,346 | | |
| 48,805,860 | |
Accumulated deficit | |
| (54,574,923 | ) | |
| (49,783,533 | ) |
Total stockholders’ equity (deficit) | |
| (1,705,494 | ) | |
| (977,612 | ) |
| |
| - | | |
| | |
Total liabilities and stockholders’ equity (deficit) | |
$ | 6,638,894 | | |
$ | 4,103,715 | |
INVO
BIOSCIENCE, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
| |
For the Three Months Ended
June 30, | | |
For the Six Months Ended
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Revenue: | |
| | | |
| | | |
| | | |
| | |
Clinic revenue | |
$ | 254,364 | | |
$ | 112,358 | | |
$ | 551,745 | | |
$ | 218,206 | |
Product revenue | |
| 61,538 | | |
| 33,777 | | |
| 112,182 | | |
| 90,527 | |
Total revenue | |
| 315,902 | | |
| 146,135 | | |
| 663,927 | | |
| 308,733 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Cost of revenue | |
| 235,714 | | |
| 170,526 | | |
| 466,719 | | |
| 367,207 | |
Selling, general and administrative | |
| 2,042,609 | | |
| 2,444,586 | | |
| 4,373,443 | | |
| 4,991,714 | |
Research and development | |
| 83,850 | | |
| 190,761 | | |
| 157,370 | | |
| 294,941 | |
Depreciation and amortization | |
| 19,705 | | |
| 22,083 | | |
| 38,792 | | |
| 37,630 | |
Total operating expenses | |
| 2,381,879 | | |
| 2,827,956 | | |
| 5,036,324 | | |
| 5,691,492 | |
Loss from operations | |
| (2,065,977 | ) | |
| (2,681,821 | ) | |
| (4,372,397 | ) | |
| (5,382,759 | ) |
Other income (expense): | |
| | | |
| | | |
| | | |
| | |
Gain (loss) from equity method joint ventures | |
| 3,788 | | |
| (117,978 | ) | |
| (23,947 | ) | |
| (189,095 | ) |
Interest income | |
| - | | |
| 48 | | |
| - | | |
| 273 | |
Interest expense | |
| (175,192 | ) | |
| (102 | ) | |
| (391,781 | ) | |
| (1,558 | ) |
Foreign currency exchange loss | |
| (265 | ) | |
| (888 | ) | |
| (400 | ) | |
| (1,914 | ) |
Total other income (expense) | |
| (171,669 | ) | |
| (118,920 | ) | |
| (416,128 | ) | |
| (192,294 | ) |
Loss before income taxes | |
| (2,237,646 | ) | |
| (2,800,741 | ) | |
| (4,788,525 | ) | |
| (5,575,053 | ) |
Income taxes | |
| 2,865 | | |
| 800 | | |
| 2,865 | | |
| 800 | |
Net loss | |
$ | (2,240,511 | ) | |
| (2,801,541 | ) | |
| (4,791,390 | ) | |
| (5,575,853 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per common share: | |
| | | |
| | | |
| | | |
| | |
Basic | |
$ | (3.06 | ) | |
$ | (4.62 | ) | |
$ | (7.07 | ) | |
$ | (9.23 | ) |
Diluted | |
$ | (3.06 | ) | |
$ | (4.62 | ) | |
$ | (7.07 | ) | |
$ | (9.23 | ) |
Weighted average number of common shares outstanding: | |
| | | |
| | | |
| | | |
| | |
Basic | |
| 732,255 | | |
| 605,760 | | |
| 677,684 | | |
| 604,123 | |
Diluted | |
| 732,255 | | |
| 605,760 | | |
| 677,684 | | |
| 604,123 | |
ADJUSTED
EBITDA
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30 | | |
June 30 | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Net loss | |
$ | (2,240,511 | ) | |
$ | (2,801,541 | ) | |
$ | (4,791,390 | ) | |
$ | (5,575,853 | ) |
Interest expense | |
| 52,474 | | |
| 54 | | |
| 90,683 | | |
| 1,285 | |
Foreign currency exchange loss | |
| 265 | | |
| 888 | | |
| 400 | | |
| 1,914 | |
Stock-based compensation | |
| 99,338 | | |
| 135,102 | | |
| 295,741 | | |
| 445,314 | |
Stock option expense | |
| 326,916 | | |
| 432,796 | | |
| 652,750 | | |
| 861,284 | |
Non-cash compensation for services | |
| 45,000 | | |
| 30,000 | | |
| 90,000 | | |
| 30,000 | |
Amortization of debt discount | |
| 122,718 | | |
| - | | |
| 301,098 | | |
| - | |
Depreciation and amortization | |
| 19,705 | | |
| 22,082 | | |
| 38,792 | | |
| 37,629 | |
Adjusted EBITDA | |
$ | (1,574,095 | ) | |
$ | (2,180,619 | ) | |
$ | (3,321,926 | ) | |
$ | (4,198,427 | ) |
| |
| | | |
| | | |
| | | |
| | |
(Gain) Loss from equity method JV | |
$ | (3,788 | ) | |
$ | 117,978 | | |
$ | 23,947 | | |
$ | 189,095 | |
Loss from consolidated JV (less depreciation) | |
| 61,486 | | |
| 132,827 | | |
| 82,354 | | |
| 311,524 | |
Adjusted EBITDA for INVO corporate | |
$ | (1,516,397 | ) | |
$ | (1,929,814 | ) | |
$ | (3,215,625 | ) | |
$ | (3,697,808 | ) |
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
June 30, | | |
For the Six Months Ended
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Statements of operations: | |
| | | |
| | | |
| | | |
| | |
Operating revenue | |
$ | 712,433 | | |
$ | 290,517 | | |
$ | 1,359,141 | | |
$ | 440,947 | |
Operating expenses | |
| (798,670 | ) | |
| (679,940 | ) | |
| (1,529,317 | ) | |
| (1,175,379 | ) |
Net income | |
$ | (86,237 | ) | |
$ | (389,423 | ) | |
$ | (170,176 | ) | |
$ | (734,432 | ) |
| |
| June 30, 2023 | | |
| December 31, 2022 | |
Balance sheets: | |
| | | |
| | |
Current assets | |
$ | 597,453 | | |
$ | 447,422 | |
Long-term assets | |
| 1,873,382 | | |
| 2,000,841 | |
Current liabilities | |
| (921,886 | ) | |
| (735,767 | ) |
Long-term liabilities | |
| (996,892 | ) | |
| (1,042,167 | ) |
Net assets | |
$ | 552,057 | | |
$ | 670,329 | |
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Grafico Azioni INVO BioScience (NASDAQ:INVO)
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