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      INVO Bioscience Reports Record Second Quarter 2019 Financial Results with Revenue Increasing 498%

      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.

      News provided by

      INVO Bioscience, Inc.

      Aug 14, 2019, 16:15 ET

      Share this article

      Share this article


      SARASOTA, Fla., Aug. 14, 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 second quarter of 2019, ended June 30, 2019.

      Q2 2019 Financial Results and Recent Highlights:

      • Revenue for the quarter totaled $658,638 compared to $110,210 in the second quarter of 2018, an increase of 498%. Revenue growth was driven primarily by increased product sales in the U.S. as shipments to Ferring were above expectations outlined in May 2019 as they began to increase their marketing activities.
      • Sequentially, revenue increased approximately 248% for the second quarter compared to $189,432 in the first quarter of 2019.
      • Gross margins for the quarter improved to approximately 92% compared to approximately 85% in the second quarter of 2018.
      • Improved net loss to $(241,552) during the second quarter compared to $(458,570) during the first quarter of 2019.
      • Company ended the quarter in a strong cash position of approximately $2.7 million.
      • Announced the appointment of Pressly Ahammed as the Company's new Director of International Business Development. Ahammed, together with Chief Operating Officer, Michael Campbell, have advanced business development efforts outside the U.S., including India, China, Latin America and the European Union.
      • 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.

      Management Discussion

      Katie Karloff, Chair and Chief Executive Officer of INVO Bioscience, commented, "We are extremely pleased that our second quarter revenues were significantly higher both year-over-year – approximately 498% and sequentially – approximately 248%. Ferring, as our U.S commercialization partner, is exceeding our expectations as they begin to increase both the number of clinics offering the INVOcell and awareness of its attributes. During the quarter we shipped nearly $500,000 in product to them, putting them well above their prorated annual minimum requirements. We are confident in Ferring's capabilities to expand adoption of the INVOcell procedure and look forward to their continued efforts to grow market share in the years to come."

      Karloff continued, "We are seeing interest from a number of international reproductive specialists to add the INVOcell technology into their respective practices in markets ranging from India, China, Latin America and the European Union. Our business development team is engaging with potential partners who have strong capabilities in these various markets and are staying diligent in our efforts to align ourselves with the best partners that can help bring INVOcell to the millions of couples around the world for which we believe it is an ideal solution to their fertility needs. Domestically, beyond Ferring's efforts, we are making consistent progress with a number of key opinion leaders in the reproductive industry to establish INVOcell centers throughout the United States with a goal to have multiple centers up and running in 2020."

      "As industry research continues to indicate, the need for affordable and effective reproductive services are highly sought after, both in the U.S. and around the world.  We believe INVOcell has an important role to play in this large and expanding global market. We have made tremendous progress over the last twelve months, particularly in the U.S. through our agreement with Ferring, and look to further advance INVOcell's adoption throughout the rest of the world in the future," Karloff concluded.

      Financial Results

      Revenue for the three months ended June 30, 2019, was $658,638 compared to $110,210 for the same three-month period in 2018, an increase of $548,428 or approximately 498%.  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 second quarter ended June 30, 2019 was approximately 92% or $603,356 compared to 85% or $93,500 for the three months ended June 30, 2018. The increase in gross margin was related to the 2019 licensing fee that did not have any cost of sales expenses associated with it. The cost of sales recognized during the second quarter of 2019 were attributed to product shipments to Ferring.

      Selling, general and administrative expenses for the three months ended June 30, 2019 were $669,152 as compared to $1,883,946 for the three months ended June 30, 2018, a decrease of $1,214,794 or approximately 64%. 

      During the three-month period ended June 30, 2019 we incurred $175,756 in interest expense compared to $74,682 in the three-month period ended June 30, 2018. The primary reason for the increase in 2019 was the amortization of discount on the 2018 Convertible Notes Payable in the amount of $163,466 as compared to $56,446 during the same period of 2018.     

      Net loss of $241,552, or $(0.00) per basic and diluted share for the three months ended June 30, 2019 compared to a net loss of $1,865,128, or $(0.01) per basic and diluted share for the three months ended June 30, 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]

      INVO BIOSCIENCE, INC.

      CONDENSED CONSOLIDATED BALANCE SHEETS









      June 30,


      December 31,



      2019


      2018

      ASSETS


      (unaudited)



      Current Assets





      Cash


      $  2,663,171


      $             212,243

      Accounts receivable, net


      240,214


      225,899

      Inventory, net


      76,475


      43,513

      Prepaid expenses and other current assets


      195,481


      249,454

         Total Current Assets


      3,175,341


      731,109






      Property and equipment, net


      98,109


      34,446






      Other Assets





      Capitalized patents, net


      9,502


      11,792

      Leasehold right of use, net


      112,827


      -

      Total other assets


      122,329


      11,792






      Total assets


      $  3,395,779


      $             777,347






      LIABILITIES AND STOCKHOLDERS' DEFICIENCY





      Current liabilities





      Accounts payable and accrued liabilities, including related parties


      $     528,640


      $             571,828

      Accrued compensation


      969,226


      2,515,256

      Deferred revenue


      727,261


      18,895

      Current portion of leasehold liability


      18,898


      -

      Note payable


      -


      131,722

      Note payable - related party


      35,000


      97,743

      Convertible notes, net of discount


      -


      157,039

      Convertible notes, net of discount - related party


      -


      9,087

      Total current liabilities


      2,279,025


      3,501,570






      Commitments and contingencies (Note 12)


      -


      -






      Leasehold liability


      94,173


      -

      Deferred revenue


      3,928,571


      -

      Convertible notes, net of discount


      232,960


      -

      Convertible notes, net of discount - related party


      20,072


      -






      Total liabilities


      6,554,801


      3,501,570






      Stockholders' Deficiency





      Preferred Stock, $.0001 par value; 100,000,000 shares authorized; No shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively


      -


      -

      Common Stock, $.0001 par value; 200,000,000 shares authorized; 155,546,112 and 154,292,497 shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively


      15,554


      15,429

      Additional paid-in capital


      19,246,768


      18,981,571

      Accumulated deficit


      (22,421,344)


      (21,721,222)

      Total stockholders' deficiency


      (3,159,022)


      (2,724,222)






      Total liabilities and stockholders' deficiency


      $  3,395,779


      $             777,348

      INVO BIOSCIENCE, INC.

      CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

      (unaudited)












      For the Three


      For the Three


      For the Six


      For the Six



      Months Ended


      Months Ended


      Months Ended


      Months Ended



      June 30,


      June 30,


      June 30,


      June 30,



      2019


      2018


      2019


      2018










      Revenue:









      Product Revenue


      $             480,067


      $             110,210


      $             490,927


      $             214,350

      License Revenue


      178,571


      -


      357,143


      -










      Total Revenue


      658,638


      110,210


      848,070


      214,350










      Cost of Goods Sold


      55,282


      16,710


      66,260


      31,134










      Gross Profit


      603,356


      93,500


      781,810


      183,216










      Selling, general, and administrative expenses


      669,152


      1,883,946


      1,196,717


      2,113,945

      Total operating expenses


      669,152


      1,883,946


      1,196,717


      2,113,945










      Loss from operations


      (65,796)


      (1,790,446)


      (414,907)


      (1,930,729)










      Other (income) expense:









      Interest (income) expense


      175,756


      74,682


      285,215


      79,122

      Total other (income) expenses


      175,756


      74,682


      285,215


      79,122










      Loss before income taxes


      (241,552)


      (1,865,128)


      (700,122)


      (2,009,851)










      Provision for income taxes


      -


      -


      -


      -










      Net Loss


      $            (241,552)


      $         (1,865,128)


      $            (700,122)


      $         (2,009,851)










      Basic net loss per weighted average shares of common stock


      $                  (0.00)


      $                  (0.01)


      $                  (0.01)


      $                  (0.01)










      Diluted net loss per weighted average shares of common stock


      $                  (0.00)


      $                  (0.01)


      $                  (0.01)


      $                  (0.01)










      Basic weighted average number of shares of common stock


      155,260,947


      147,316,458


      154,873,694


      145,339,696










      Diluted weighted average number of shares of common stock


      155,260,947


      147,316,458


      154,873,694


      145,339,696

      INVO BIOSCIENCE, INC.

      CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

      (unaudited)






      For the Six


      For the Six


      Months Ended


      Months Ended


      June 30,


      June 30,


      2019


      2018

      Cash flows from operating activities:




      Net Loss

      $            (700,122)


      $         (2,009,851)

      Adjustments to reconcile net loss to net cash provided by operating activities:




      Non-cash stock compensation issued for services

      26,600


      1,743,464

      Amortization of discount on notes payable

      256,703


      56,446

      Amortization of leasehold right of use asset

      3,614


      -

      Depreciation and amortization

      3,465


      2,268

      Changes in assets and liabilities:




      Accounts receivable

      (14,315)


      (52,696)

      Inventories

      (32,962)


      (522)

      Prepaid expenses and other current assets

      53,974


      21,619

      Accounts payable and accrued expenses

      1,280


      (167,131)

      Leasehold liability

      (3,370)


      -

      Deferred revenue

      4,636,937


      -

      Accrued interest

      24,458


      -

      Accrued compensation

      (1,546,030)


      156,900

      Net cash provided by (used in) operating activities

      2,710,232


      (249,503)





      Cash from investing activities:




      Payments to acquire property, plant, and equipment

      (64,839)


      -

      Net cash used in investing activities

      (64,839)


      -





      Cash from financing activities:




      Proceeds from the sale of common stock

      -


      47,000

      Proceeds from the sale of common stock - related parties

      -


      30,000

      Proceeds from convertible notes payable

      -


      855,000

      Proceeds from convertible notes payable - related parties

      -


      40,000

      Principal payment on notes payable

      (131,722)


      -

      Principal payment on notes payable - related parties

      (62,743)


      (28,000)

      Net cash provided by (used in) financing activities

      (194,465)


      944,000





      Increase in cash and cash equivalents

      2,450,928


      694,497





      Cash and cash equivalents at beginning of period

      212,243


      25,759





      Cash and cash equivalents at end of period

      $          2,663,171


      $             720,256





      Supplemental disclosure of cash flow information:








      Cash paid during the period for:




      Interest

      $                 9,823


      $                         -





      Leasehold right of use asset and leasehold liability upon adoption of ASU 2016-02, lease (Topic 842)

      $             116,441


      $                         -





      Taxes

      $                         -


      $                    912





      Common stock issued upon note payable and accrued interest conversion

      $             238,723


      $                         -





      Common stock issued for prepaid services

      $                         -


      $             153,000





      Beneficial conversion feature on convertible notes

      $                         -


      $             895,000

      SOURCE INVO Bioscience, Inc.

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