Corporate PresentationMay 2020
OTCQB: INVO
This presentation 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. 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 Safety and Efficacy information: https://invobioscience.com/wp-content/uploads/2018/11/P-008_INVO-IFU-Nov-2018.pdf
FORWARD LOOKING STATEMENTS
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INVO has created the INVOcell an FDA-cleared Device
A disruptive and novel fertility treatment option compared to traditional In-Vitro Fertilization
COMPANY HIGHLIGHTS
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FDA Cleared; CE Mark; Patented Device
$17-$20 Billion Industry Growing at 8-10%
Annually
Pivotal U.S. Commercialization Agreement with Industry Leader
(Ferring Pharmaceuticals)
Vast Underserved Global Market 95%+ of Infertile
Couples go Untreated
A Significant Unmet Market Opportunity
INVOcell Addresses Critical Industry Challenges
Regarding Treatment Cost & Capacity Constraints
Ability to Help Treat the Underserved Couples
Commercialization Internationally, with
Recent Distribution & JV Agreements Signed
199% Revenue Growth in 2019
Source: Allied Market Research, Grandview Research, CDC
THE INVOcell SYSTEM
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CULTURE DEVICE
RETENTION DEVICE
The culture device holds the eggs and sperm. It is about 1.5 inches
tall and just over 1 inch wide.
The retention device, with the culture device in it, is then placed
in the vaginal cavity.
INNER CHAMBEREggs & sperm are placed in the Inner
Chamber of the Culture Device
1.5”
1”
THE INVO PROCEDURE
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INVOcell is the first intravaginal culture (IVC) device used for the incubation of eggs and sperm during fertilization and early embryo development
Uses the women’s body for natural incubation as an alternative to traditional in-vitro fertilization (IVF) that uses incubators for fertilization and embryo development
IUI was reported tohave an 8-10% rate of clinical
pregnancy success
Retrospect data reflected a~52% clinical pregnancy success
rate, based on Society for Assisted Reproductive Technology (SART) 2018
preliminary national data (5-day incubation).
Retrospect data reflected a~59% clinical pregnancy success rate,
based on Society for Assisted Reproductive Technology (SART) 2018
(5-day) preliminary national data.
INVOcell SUCCESS – PATIENT OUTCOMES
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INVOcell (IVC)
~52%SUCCESS
IUI
8-10%SUCCESS
IVF
~59%SUCCESS
Infertility Treatment Options
Source: ESHRE, SART
SIGNIFICANTLY UNDERSERVED MARKET
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7% - 15% Estimated percentage of reproductive age women
suffer from infertility worldwide
~2.5 MIVF cycles performed
worldwide
<5%Large underserved patient
base with only a small percentage receiving care
Served Underserved
Over 95% of the infertile couples remain untreated resulting in a significant unmet market opportunity.
Source: ASRM, SART, CDC
INDUSTRY CHALLENGES
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INVOcell Helps Address The Two Biggest Infertility Industry Challenges
Treatment Costs► Relative high costs for IVF treatment – reduces
affordability for many
Infrastructure and Capacity Constraints► Limited number of IVF clinics – and clustered in
population centers, which drives up costs for patients in rural areas
► Clinic throughput (volume limits) – lab capacity limitations
► Industry simply does not have enough capacity to handle the needs
$17-20 BillionThe global infertility market is estimated to be $17-20 billion
Growing at 8–10% per year
Source: Allied Market Research, Grandview Research, CDC
Analysis indicates that a 50% reduction in the price of IVF services would translate into a 160% increase in utilization of such services.
KEY BARRIERS TO TREATMENT: COST
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1.5 1.5
2.4
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
4.5
Current # of WW IVF Procedures Implied Growth in IVC Based on Cost/Benefit
# of
IVF/
IVC
Proc
edur
es (i
n M
illio
ns)
Cost Has Been Identified As The #1 Barrier To Utilization Of IVF
Source: Chambers, Georgina M. et al. "The Impact Of Consumer Affordability On Access To Assisted Reproductive Technologies And Embryo Transfer Practices: An International Analysis". Fertility and Sterility 101.1 (2014): 191-198.e4. Web.
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HOW DOES INVOcell SAVE COSTS?
LESS LABORATORYSPACE NEEDED
FEWERULTRASOUNDS
FEWERAPPOINTMENTS
LESS MEDICATION
Fertilization, Conception And Embryo Development Occur Inside The Body Not In A Laboratory
NATURALINCUBATION
PATIENTSAVINGS
Traditional IVFtreatment with medication
$12,000 - $15,000 PER CYCLE*
VS
$5,000 - $9,000PER CYCLE*
INVOcell IVC treatment with medication
* Excluding optional add-on’s (ICSI, Egg Freezing, Genetic Testing)
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PATIENT ADVANTAGES
INVOcell
Equivalent Pregnancy Rates
Low Cost Per Cycle
Improved Accessibility To Treatment
Natural And Emotionally Connected Experience
Reduced Risk Of Lab Mistakes
Fewer Drugs – Lower Stimulation
COMMERCIALIZATION
MULTI-PRONGED COMMERCIALIZATION STRATEGY
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DISTRIBUTION JOINT VENTURE
► Potentially upfront rights fee
► INVO Bioscience to supply INVOcell device at predetermined pricing
► Country/region exclusivity likely
► Minimum purchase obligations
► Partner with operator to create dedicated INVOcell Clinics
► INVO Bioscience to provide the device, training and general technology/lab support
► JV partner will be responsible for the operations of the INVOcell clinics, including entire IVC process
► U.S. and International
U.S.: FERRING DISTRIBUTION
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Ferring Pharmaceuticals Commercialization AgreementJanuary 2019
► INVO Bioscience and Ferring Pharmaceuticals entered into an exclusive U.S. license and distribution/supply agreement for INVOcell® – Executed in January 2019.
► $5M up front payment received upon signing; $3M additional payment due upon completion of specific milestone (5-day label enhancement); supply agreement
► Ferring will be responsible for all U.S. commercial activities for INVOcell, excluding opportunities INVO Bioscience retains to establish INVO-only clinics.
► Ferring is required to purchase annual minimum device quantities from INVO in order to maintain U.S. exclusivity during the 7-year term.
► INVO Bioscience will be responsible for manufacturing and supplying product to Ferring.
Market = ~ 284,000 IVF Cycles per Year
AFRICA/EURASIA: DISTRIBUTION
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Africa/EurasiaDistribution AgreementsQ4 2019
► INVO Bioscience entered into commercialization agreements in the continent of Africa with G-Systems covering Nigeria, and Quality Medicine covering Uganda, Sudan and Ethiopia. Following standard administrative requirements by each company to begin supplying INVOcell in the country, the Company believes distribution will commence in 2020. Each agreement includes minimum annual purchase requirements.
► INVO Bioscience entered into distribution agreements with OrcanMedical for Turkey, a leading medical distributor to large medical device companies including St. Jude Medical, Cooper Surgical, and Clarus, within the country. Orcan Medical will become the exclusive commercial partner for INVOcell in Turkey, contingent upon minimum purchase and other requirements.
► INVO Bioscience entered into distribution agreements with Biovate covering Jordan. Biovate will act as the exclusive distribution partner for INVOcell in the country following standard administrative requirements to begin supplying INVOcell in the country.
~ 125,000 IVF Cycles per Year
INDIA: MEDESOLE JOINT VENTURE
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Medesole Healthcare and Trading Pvt LtdJoint VentureJanuary 2020
► INVO Bioscience and Medesole entered into joint venture to operate dedicated INVOcell clinics in India in January 2020.
► Under terms of the agreement, INVO Bioscience and Medesole will each own 50% of the joint venture. INVO Bioscience will provide the device, training and general technology support to the joint venture, while Medesole will be responsible for the operations of the INVOcell clinics in India. Both partners will equally invest in start-up and capital expenditures and share in the revenue and profits of the joint venture.
► Medesole INVO Bioscience Private Limited, has set an initial objective of opening three INVOcell clinics over the next 12 months, with additional clinics planned in subsequent years. Based on the initial first year plan, INVO Bioscience anticipates it will invest approximately $150,000 to $200,000 in the JV. Subsequent investments will be based on JV performance and mutual agreements between INVO Bioscience and Medesole.
~ 110,000 IVF Cycles per Year
KEY INTERNATIONAL TARGET MARKETS
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China
► Active Discussions► JV-Type Focus► ~700,000 IVF Cycles Per Year
Europe
► Multiple Markets In Discussion► Various Types► ~700,000 IVF Cycles Per Year
► Active Discussions ► Partnership
Mexico
► Multiple Markets In Discussion ► Various Types
South America
► Multiple Markets In Discussion► Various Types
Other Southeast Asia
► Registration Underway ► Seeking Partner► ~450,000 IVF Cycles Per Year
Japan
LABEL EXPANSIONOPPORTUNITY TO RECEIVE $3 MILLION MILESTONE PAYMENT
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Expand INVOcell Label to 5-day Incubation
In February 2020, IRB approval to begin clinical pivotal trial ► Single arm, multicenter, open label trial at three clinical sites in the United States
with each site enrolling 60 patients between the ages of 18 and 37 years old.
Align marketing with current standard IVF treatment
Update INVOcell clinical success rate
Receive $3 million milestone payment from Ferring
Expand currently approved label from 3-day incubation to 5-day incubation
KEY ACCOMPLISHMENTS AND 2020 GOALS
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Recent Accomplishments 2020 Goals
Signed major U.S. commercialization agreement
Expand international business development team
Expand regulatory clearance in key countries, including CE Mark
Sign first major international distribution agreements
Sign first joint venture agreement to open INVOcell clinics
Diversify and expand revenue base with a goal to more than double product revenues
Open first INVOcell clinics
Complete 5-day label Clinical Study
Sign additional major international agreements (JV or distribution)
Continue to improve Public Company profile and overall investor base
REVENUE
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$11,689 $50,901
$282,145
$494,375
$1,480,213
$0
$200,000
$400,000
$600,000
$800,000
$1,000,000
$1,200,000
$1,400,000
$1,600,000
2015 2016 2017 2018 2019
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INCOME STATEMENTConsolidated Statement of Operations
For the Twelve For the Twelve For the Twelve For the Twelve For the TwelveMonths Ended Months Ended Months Ended Months Ended Months EndedDecember 31, December 31, December 31, December 31, December 31,
2019 2018 2017 2016 2015
Revenue:Product Revenue 765,927$ 494,375$ 282,145$ 50,901$ 11,689$ License Revenue 714,286$ -$ -$ -$ -$
Total Revenue 1,480,213$ 494,375$ 282,145$ 50,901$ 11,689$
Cost of sales 139,670 90,367 51,954 15,094 7,810
Gross margin 1,340,543 404,008 230,191 35,807 3,879
Selling, general and administrative expenses 3,128,635 3,038,068 870,612 2,146,221 598,953 Total Operating Expenses 3,128,635 3,038,068 870,612 2,146,221 598,953
Loss from Operations (1,788,092) (2,634,060) (640,421) (2,110,414) (595,074)
Total other expenses 379,019 442,031 61,742 13,838 4,364,173
Income (Loss) before income taxes (2,167,111) (3,076,091) (702,163) (2,124,252) (4,959,247)
Provision for income taxes - - - - -
Net Loss (2,167,111)$ (3,076,091)$ (702,163)$ (2,124,252)$ (4,959,247)$
Basic net loss per weighted average shares of common stock (0.02)$ (0.02)$ $ (0.00) (0.02)$ (0.04)$
Diluted net loss per weighted average shares of common stock (0.02)$ (0.02)$ $ (0.00) (0.02)$ (0.04)$
Basic weighted average number of shares of common stock 155,356,091 147,333,051 141,305,050 139,196,557 128,567,615
Diluted weighted average number of shares of common stock 155,356,091 147,333,051 141,305,050 139,196,557 128,567,615
KEY STATISTICS
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INVO Bioscience (OTCQB: INVO) Data as of 5/15/2020
Market Cap $29 million
Stock Price | 52-Week Range $0.18 | $0.11 - $0.43
Basic Shares Outstanding 158 million
FD Shares Outstanding 172 million
Management Ownership 23%; 50% when including founder and certain key holders
Free Trading Shares 52 million
Cash (03/31/20) $0.35 million (*Company completed $2.1 million funding post Q end)
KEY RECENT EVENTS
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Private placement funding of $2.1 million
2018 INVOcell (IVC) outcomes data published by Society for Assisted Reproductive Technologies (SART)
Q1 2020 Financial results
Expanded Business Development and Medical Affairs with Key Appointments
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INVESTMENT RECAP
INDUSTRY
PRODUCT
Commercialization
► Multi-billion dollar, large and growing global market opportunity
► Significantly underserved market
► Revolutionary, FDA-cleared device, that we believe is a major breakthrough in the fertility industry.
► High margins
► Commercialization efforts greatly enhanced with recently-signed partnership with Ferring, a multi-billion pharma company; along with large international opportunities
MANAGEMENT
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Steven M. ShumChief Executive Officer and DirectorRecently served as Chief Financial Officer of Eastside Distilling (NASDAQ: EAST) since October 2015. Prior to joining Eastside, Mr. Shum served as an Officer and Director of XZERES Corp, a publicly-traded global renewable energy company, from October 2008 until April 2015 in various officer roles, including Chief Operating Officer from September 2014 until April 2015, Chief Financial Officer, Principal Accounting Officer and Secretary from April 2010 until September 2014 (under former name, Cascade Wind Corp) and Chief Executive Officer and President from October 2008 to August 2010.
Michael J. CampbellCOO and Vice President of Business Development and DirectorMost recently the Vice President of IVF Americas Business Unit for Cooper Surgical, Inc. (CSI), a wholly owned subsidiary of The Cooper Companies (NYSE: COO). Mr. Campbell has substantial medical device sales, marketing and business development leadership experience within Global Fortune 500 and Start-up Company environments.
Lori KahlerVice President of Global OperationsOver 25 years domestic and international experience in operations, quality, regulatory, compliance and clinical affairs, with proficiency across a full range of business functions and systems. Lori was instrumental in achieving FDA De Novo clearance for INVO Bioscience’s innovative INVOcell System.
Christopher MyerVice President of Business Development - AmericasMr. Myer most recently served for four years in the Fertility and Genomics Group at CooperSurgical, Inc as Director, Corporate Accounts and Strategic Relationships – North America; and was previously Regional Sales Director, Fertility & Genomics Business Unit in the mid-Atlantic and Southeast region of the U.S. Mr. Myer also worked at leading medical device and capital equipment companies including Alliance Healthcare and McKesson Corporation.
Kevin Doody MDMedical Director and DirectorRenowned fertility specialist who is the founder and Medical Director for the Center for AssistedReproduction (CARE Fertility) and Effortless IVF located in Bedford Texas. Dr. Doody is President of theSociety for Assisted Reproductive Technology (SART), on the Board of Directors of the American Society forReproductive Medicine (ASRM) and a member of the RESOLVE Physician Council.
Kathleen KarloffChair of Board and former CEOOver 30 years of experience in medical device and pharmaceutical manufacturing, clinical operations, regulatory affairs and quality systems with 13 years at Boston Scientific and 18 years on the senior management teams of start-up organizations.
Pressly AhammedDirector of International Business DevelopmentHas worked over the last 11 years in numerous segments of the international healthcare sector including hospitals; wholesale and retail sectors; and distribution. Ahammed joined INVO Bioscience from Cooper Surgical, where he held a similar title focused on women's healthcare business development in Eastern Europe, the Middle East, Africa, and South and Central Asia.
Inger Britt Carlsson, PhDVice President of Global Medical AffairsWith over 30 years' experience in the fertility industry, Dr. Carlsson was most recently Global Director of Medical Affairs for CooperSurgical Fertility and Genomics. Prior to CooperSurgical, she was Associate Director-Medical Affairs for EMD Serono from 2014 to 2015. She has also served as Medical Science Liaison-Medical Affairs for Sanofi Aventis (formerly Genzyme) and Medical Science Liaison-Women's Health for Merck (formerly Schering-Plough).
Yve LyppensDirector Business Development - Asia PacificJoined INVO with more than a decade of experience in sales and distribution management. From 2016 to the present, he served as Asia Pacific Sales Director for Biomedic Hong Kong Ltd., a medical device distributor in Mainland China. Prior to that, from 2011 to 2016, Mr. Lyppens served as a Director, Shareholder and Sales Manager at F Care Systems Hong Kong Ltd., a developer and exporter of medical aesthetics equipment.
PATENTS & APPROVALS
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► Container assembly for intravaginal fertilization and culture and embryo transfer and method of intravaginal culture employing such a container► Europe, China, and Japan
► Incubation and/or storage container system and method► Patent #US 7,759,115. Additional patents pending► US, Europe, UK, France, Germany, Russia and India
► Registrations► United States
► FDA Clearance of De Novo Class II device in November 2, 2015► Canada
► Health Canada approved► Europe
► CE Mark (received Oct 2019)► India
► Product registered► Brazil
► ANVISA approved► Colombia
► New INVIMA in process► Mexico
► Registration in process.