Form 8-K - Current report

 

 

 

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)

 

[phone]

(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

 

Exhibit No.		Description
99.1		Press Release dated August 14, 2024.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document.)

 

-2-

 

 

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

 

-3-

 

 

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

[e-mail]

 

INVO Investor Contact:

 

Robert Blum (Lytham Partners, LLC)

602-889-9700

[e-mail]

 

 

 

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

 

 

Cover	Aug. 14, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 14, 2024
Entity File Number	001-39701
Entity Registrant Name	INVO BIOSCIENCE, INC.
Entity Central Index Key	0001417926
Entity Tax Identification Number	20-4036208
Entity Incorporation, State or Country Code	NV
Entity Address, Address Line One	5582 Broadcast Court
Entity Address, City or Town	Sarasota
Entity Address, State or Province	FL
Entity Address, Postal Zip Code	34240
City Area Code	(978)
Local Phone Number	878-9505
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.0001 par value
Trading Symbol	INVO
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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