INVO Bioscience Reports Third Quarter 2019 Financial Results

SARASOTA, Fla., Nov. 14, 2019 /PRNewswire/ -- INVO Bioscience, Inc. (OTCQB: IVOB), a medical device company focused on creating alternative treatments for patients diagnosed with infertility and developers of INVOcell®, the world's only in vivo Intravaginal Culture System, today announced financial results for the third quarter of 2019, ended September 30, 2019.

Q3 2019 Financial Results:

• Revenue for the quarter totaled $303,571 compared to $125,035 in the third quarter of 2018, an increase of 143%. Revenue growth was driven primarily by increased product sales in the U.S. as shipments to Ferring as they continue to increase their marketing activities.
• Gross margins for the quarter were approximately 85% compared to approximately 88% in the third quarter of 2018.
• Incurred a net loss of $(710,334) during the third quarter compared to a net loss of $(294,860) during the third quarter of 2018, as a result of increased commercialization efforts and certain one-time settlement costs.
• Company ended the quarter with a cash position of approximately $2.0 million.

International Expansion Highlights

• The Company commenced its worldwide rollout for INVOcell with the recent signing of commercialization agreements covering Nigeria, Turkey, Jordan, Uganda, Ethiopia, and Sudan.
• Attained receipt of a CE Mark for the INVOcell culture and retention device in October 2019, the final requirement to begin commercially distributing the revolutionary alternative to traditional IVF through the entire European Union.

Management Discussion

Steve Shum, Chief Executive Officer of INVO Bioscience, commented, "We are excited with the progress being made to drive revenue growth domestically through our U.S. commercialization agreement with Ferring and now in other parts of the world with the recent signing of new commercial distribution agreements for Nigeria, Turkey, Jordan, Uganda, Ethiopia, and Sudan. We believe there is an incredible opportunity to drive adoption of the INVOcell over the coming years through the creation of commercialization agreements with partners. We will remain diligent to find partners that are incentivized to support the product through minimum purchase requirements or similar arrangements. Our agreement with Ferring for the U.S. and our recent agreements for Africa and Eurasia are great templates to continue working from and we look forward to further agreements announced in the future."

Shum continued, "Other near-term objectives include the initiation of our follow-on clinical study for the INVOcell device to expand the current label from a 3-day incubation period to a 5-day incubation period. As part of the Ferring agreement, if we achieve 5-day labeling approval from the FDA, we receive an additional $3 million non-dilutive milestone payment. In addition to the milestone payment, the new study will allow us to update our clinical data which we believe will allow us to show improved clinical pregnancy and birth rates and further enhance the value proposition we can provide to the market as an alternative to traditional IVF."

"Our technology is a simple and more natural solution, with comparable rates of effectiveness to existing options at lower costs, that has been designed to help the millions of couples worldwide that struggle with infertility but are currently unable to receive treatment. We are beginning to put in place the commercialization strategy that can allow for the proliferation of this technology which I believe has the ability to significantly enhance shareholder value," concluded Shum.

Financial Results

Revenue for the three months ended September 30, 2019, was $303,571 compared to $125,035 for the same three-month period in 2018, an increase of $178,536 or approximately 143%.  The increase was primarily the result of increased product sales as Ferring began to increase their marketing activities as well as from recognizing 3.6% of the Ferring seven-year U.S. exclusive licensing & distribution fee.    

Gross margin reported for the third quarter ended September 30, 2019 was approximately 85% or $258,645 compared to 88% or $109,666 for the three months ended September 30, 2018. The slight decrease in gross margin relates to the lower average selling price on product sales as compared to last year, due to the fixed price the Company now sells to Ferring under the agreement, which was partly offset by the amortization of the up-front license payment. 

Selling, general and administrative expenses for the three months ended September 30, 2019 were $891,008 as compared to $299,548 for the three months ended September 30, 2018, an increase of $591,460 or 197%. The increase in SG&A during the third quarter of 2019 compared to the third quarter of 2018 was primarily the result of an increase in wages, professional fees, legal fees (including certain one-time settlement costs totaling $180,000) and other corporate expenses, part of which are associated with our plans to accelerate our various commercialization efforts.

During the three-month period ended September 30, 2019 we incurred $47,462 in interest expense, a decrease of $57,516, or 55%, compared to $104,978 in the three-month period ended September 30, 2018. The primary reason for the decrease in 2019 was the amortization of discount on the 2018 Convertible Notes Payable in the amount of $40,355 as compared to $79,771 during the same period of 2018.

Net loss of $710,334, or $(0.00) per basic and diluted share for the three months ended September 30, 2019 compared to a net loss of $294,860, or $(0.00) per basic and diluted share for the three months ended September 30, 2018.

Webcast

The Company will hold a live investor webcast next week to discuss the results and provide investors an overview of the Company and its strategy.

Date and Time: 11:00am ET (8:00am PT) on Thursday, November 21, 2019.

Live Webcast Information: Interested parties can access the conference call via a live Internet webcast, which is available in the Investor Relations section of the Company's website at https://invobioscience.com/investors/.

Questions: The webcast will be moderated by Lytham Partners. To submit a question in advance of the webcast, please email it to [email protected].

Replay: A webcast replay will be available for 90 days in the Investor Relations section of the Company's website at https://invobioscience.com/investors/.

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
Steve Shum, CEO
978-878-9505
[email protected]  

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

SOURCE INVO Bioscience, Inc.