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 — 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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SOURCE INVO Bioscience, Inc.