INVO Bioscience Reports First Quarter 2019 Financial Results

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.

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
[email protected] 

Investors
Lytham Partners, LLC
Robert Blum
602-889-9700
[email protected]

Financial Tables to Follow

SOURCE INVO Bioscience, Inc.