MEDFORD, Mass., May 15, 2019 /PRNewswire/ — INVO Bioscience, Inc. (OTCQB: IVOB), a medical device company which was granted FDA clearance for its Intravaginal Culture System, INVOcell™, today announced financial results for the first quarter of 2019, ended March 31, 2019.

INVO Bioscience (IVOB) is a medical device company, headquartered in Medford, Massachusetts, focused on creating simplified, lower cost treatment options for patients diagnosed with infertility. The company's lead product, the INVOcell, is a novel medical device used in infertility treatment that enables egg fertilization and early embryo development in the woman's vaginal cavity.

Financial Results and Recent Highlights:

  • Revenue for Q1 2019 increased 82% to $189,432 compared to $104,140 for the comparable quarter in 2018;
  • On January 14, 2019 the Company closed an exclusive U.S. licensing agreement with Ferring International Center S.A. the parent Company of Ferring Pharmaceuticals U.S. to commercialize the INVOcell™ system for use in the treatment of infertility.
  • As part of the U.S. licensing agreement the Company received a $5 million one-time milestone payment, with the ability to receive an additional $3 million upon obtaining a label enhancement from the U.S. Food and Drug Administration;
  • During the quarter the Company appointed Michael J. Campbell as Chief Operating Officer and Vice President of Business Development to head up the Company’s planned commercialization efforts internationally, as well as oversee the launch of the INVO clinic strategy in the United States;
  • Q2 2019 revenue expected to increase significantly due to initial commercial scale shipments made to Ferring during April of approximately $275,000 with further shipments anticipated. This product order, coupled with the prorated proportion of the licensing agreement should result in second quarter revenues to be more than $450,000.

Management Discussion

Katie Karloff, Chair and Chief Executive Officer of INVO Bioscience, commented, «We expect 2019 to be a pivotal year in the history of INVO Bioscience. We are building the foundation of the business with three main pillars. The first pillar is our exclusive U.S. partnership with Ferring Pharmaceuticals, a leader in the reproductive health industry. Ferring will provide the necessary sales and marketing resources to more fully develop the market in the United States. There are countless couples not able to receive reproductive treatments today, and Ferring can be instrumental in addressing the unmet needs of this cohort. Ferring has the industry experience, relationships and the marketing capabilities to successfully embed the INVOcell in clinics throughout the country. We look forward to their market expansion for many years.»

«The other two pillars – marketing the INVOcell internationally and establishing a series of INVO clinical labs throughout the U.S. is beginning to take shape. During the quarter we hired Michael J. Campbell as Chief Operating Officer and Vice President of Business Development to commercialize the INVOcell internationally, and to execute on the development of our INVO clinic lab model in the United States. In a career that spans more than 30 years, Mike has substantial medical device sales, marketing, as well as international business development leadership experience with Fortune 500 and start-up companies alike, including Cooper Surgical and Boston Scientific. Mike has hit the ground running in approaching his contacts in Europe, the Middle East and Asia and is beginning to gain traction.»  

Ms. Karloff concluded, «We are well positioned to execute on our business plan. We have the product, the people and the strategic partnership with Ferring to move our company forward in the coming years.»

Financial Results

Revenue for the three months ended March 31, 2019, was $189,432 compared to $104,140 for the same three-month period in 2018, an increase of $85,292 or 82%.  The increase was the result of recognizing 3.6% of the Ferring seven year U.S. exclusive licensing & distribution fee that was recorded as deferred revenue in January 2019 upon the execution of the agreement.

From a device sales standpoint, the first quarter represented a transition period to the Ferring licensing and distribution agreement.  The Company shipped minimal product during the quarter as INVO and Ferring worked to develop packaging and other key commercialization tasks.  Subsequent to the first quarter end, the Company shipped initial orders of approximately $275,000 in April with further shipments anticipated. This product order, coupled with the prorated proportion of the licensing agreement should result in second quarter revenues to be more than $450,000.

The gross margin reported for the first quarter ended March 31, 2019 was 94% or $178,454 compared to 86% or $89,716 for the three months ended March 31, 2018.

Selling, general and administrative expenses for the three months ended March 31, 2019 were $527,565 as compared to $229,999 for the three months ended March 31, 2018, an increase of $297,566 or 129%.  The increase in SG&A during the first quarter of 2019 compared to the first quarter of 2018 was the result of increased staff, along with initial site development work for INVO clinical labs, and increased U.S. and international travel related to our efforts to develop additional partnerships.

During the three-month period ended March 31, 2019 the Company incurred $109,459 in interest expense, an increase of $105,019 compared to $4,440 in the three-month period ended March 31, 2018. The primary reason for the increase in 2019 was the amortization of discount on the 2018 Convertible Notes Payable in the amount of $93,237 along with $13,982 of interest for the same notes.  In the first three months of 2019 the Company had $2,240 of note payable interest compared to note payable interest of $4,440 the first quarter of 2018.

The Company reported a net loss of $458,570, or $(0.00) per basic and diluted share for the three months ended March 31, 2019, compared to a net loss of $144,723, or $(0.00) per basic and diluted share for the three months ended March 31, 2018.

About INVO Bioscience

We are a medical device company focused on creating simplified, lower cost treatments for patients diagnosed with infertility. Our solution, the INVO Procedure, is a disruptive new technology. The INVO Procedure is a revolutionary in vivo method of vaginal incubation that offers patients a more natural and intimate experience. Our lead product, the INVOcell, is a patented medical device used in infertility treatment and is considered an Assisted Reproductive Technology (ART). The INVOcell is the first Intravaginal Culture (IVC) system in the world used for the natural in vivo incubation of eggs and sperm during fertilization and early embryo development, as an alternative to traditional In Vitro Fertilization (IVF) and Intrauterine Insemination (IUI). Our mission is to increase access to care and expand fertility treatment across the globe with a goal to lower the cost of care and increase availability of care. For more information, please visit http://invobioscience.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.

For more information, please contact:

INVO Bioscience
Kathleen Karloff, CEO
978-878-9505 ext. 504
kkarloff@invobio.com 

Investors
Lytham Partners, LLC
Robert Blum
602-889-9700
IVOB@lythampartners.com

Financial Tables to Follow

INVO BIOSCIENCE, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

March 31,

December 31,

2019

2018

ASSETS

(unaudited)

Current assets

    Cash

$

3,057,466

$

212,243

    Accounts receivable net

74,717

225,899

    Inventory, net

51,685

43,513

    Prepaid expense and other current assets

226,696

249,454

      Total current assets

3,410,564

731,109

Property and equipment, net

81,709

34,446

Other Assets:

Capitalized patents, net

10,958

11,792

Total other assets

10,958

11,792

Total assets

$

3,503,231

$

777,347

LIABILITIES AND STOCKHOLDERS’ DEFICIENCY

Current liabilities

     Accounts payable and accrued liabilities, including related parties

$

588,354

$

571,828

     Accrued compensation

932,661

2,515,256

     Deferred revenue

4,840,323

18,895

     Note payable

131,722

     Note payable – related party

35,000

97,743

     Convertible notes, net of discount

196,883

157,039

     Convertible notes, related party – net of discount

12,480

9,087

          Total current liabilities

6,605,701

3,501,570

     Note payable – long term

Total liabilities

6,605,701

3,501,570

Commitments and contingencies

Stockholder’s deficiency

Preferred Stock, $.0001 par value; 100,000,000 shares authorized;

No shares issued and outstanding as of March 31, 2019 and December 31 2018, respectively

Common Stock, $.0001 par value; 200,000,000 shares authorized; 154,621,112 and 154,292,497

issued and outstanding as of March 31, 2019 and December 31, 2018, respectively

15,461

15,429

   Additional paid-in capital

19,061,861

18,981,570

   Accumulated deficit

(22,179,792)

(21,721,222)

      Total stockholder’s deficiency

(3,102,470)

(2,724,223)

Total liabilities and stockholders’ equity

$

3,503,231

$

777,347

  

INVO BIOSCIENCE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

For the

For the

Three Months

Three Months

Ended

Ended

March 31,

March 31,

2019

2018

Revenue

$

189,432

$

104,140

Cost of Goods Sold

10,978

14,424

Gross Margin

178,454

89,716

Selling, general and administrative expenses

527,565

229,999

      Total operating expenses

527,565

229,999

Loss from operations

(349,111)

(140,283)

Other (income) expense:

Interest expense

109,459

4,440

 Total other (income) expenses

109,459

4,440

Loss before income taxes

(458,570)

(144,723)

Provisions for income taxes

Net Loss

$

(458,570)

$

(144,723)

Basic net loss per weighted average shares of common stock

$

(0.00)

$

(0.00)

Diluted net loss per weighted average shares of common stock

$

(0.00)

$

(0.00)

Basic weighted average number of shares of common stock

154,102,856

143,340,969

Diluted weighted average number of shares of common stock

154,102,856

143,340,969

  

INVO BIOSCIENCE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

For the

For the

Three Months

Three Months

Ended

Ended

March 31,

March 31,

2019

2018

Cash flows from operating activities:

   Net loss

$

(458,570)

$

(144,723)

Adjustments to reconcile net income (loss) to net cash provided by operating activities:

     Non-cash stock compensation issued for services

26,600

181,664

     Depreciation and amortization

1,971

1,134

     Amortization of discount on notes payable

93,237

Changes in assets and liabilities:

     Accounts receivable

151,182

(24,160)

   Inventories

(8,172)

3,939

      Prepaid expenses and other current assets

22,758

(12,523)

      Deferred revenue

4,821,428

      Accounts payable and accrued expenses

20,249

(124,884)

      Accrued compensation

(1,582,595)

82,200

   Net cash provided by (used in) operating activities

3,088,088

(37,353)

Cash from investing activities:

    Payments to acquire property, plant and equipment

(48,400)

Net cash used in investing activities

(48,400)

Cash from financing activities:

     Cash paid for related party notes payable

(62,743)

     Cash paid for notes payable

(131,722)

     Proceeds from the sale of common stock

47,000

Net cash (used in) provided by financing activities

(194,465)

47,000

Increase in cash and cash equivalents

2,845,223

9,647

Cash and cash equivalents at beginning of period

212,243

25,759

Cash and cash equivalents at end of period

$

3,057,466

$

35,406

Supplemental disclosure of cash flow information:

Cash paid during the period for:

Interest

$

9,879

$

Taxes

$

912

$

912

Common stock issued for conversion of notes payable

$

53,723

$

 

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SOURCE INVO Bioscience, Inc.