Transcript A New Unique Fertility Treatment

INVO Bioscience
A Unique New Fertility
Treatment
June 2009
Forward Looking 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. 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.
Stock Overview
(as of 6/18/09)
Exchange:
Symbol:
Recent Price:
Market Cap:
52 Week Range:
Shares Outstanding:
Approximate Float:
OTC BB
IVOB
$.15
$8.2M
$.05- $5.50
53.7 M
14 M
Introduction
• INVO Bioscience went public via a reverse merger in December 2008.
INVO began trading under the symbol IVOB in February 2009.
• INVO is introducing a new device for Intra-vaginal culture to the
infertility market.
•
This is a fertility treatment similar to In-vitro Fertilization (IVF) but
simpler to perform and can be made more available to the infertile
population worldwide reaching patients that cannot currently be
treated by traditional IVF.
• The procedure may be provided without an IVF center and therefore
can be available in many more locations than IVF. INVO is well
positioned to capture a significant share of the unmet market needs.
Un-addressed Infertility
• 150 million infertile couples worldwide (ESHRE 2007)
• 1 million technological procedures that help infertile couples to conceive have
been performed worldwide
• Less than .5% are treated with and average of 2+ cycles per couple
• Over 149 million infertile couples go untreated, this is the population INVO
is targeting
• Reasons for lack of treatment
• Cost
• Availability
• Awareness
INVO Bioscience Goal
Reach the unmet needs of the Infertility population
through providing
•
•
•
•
A
A
A
A
unique new fertility treatment
geographically available treatment
less expensive treatment
more natural treatment
Market Strategy
•
INVO Bioscience is not competing with IVF
•
INVO allows IVF clinics to open low cost INVO centers to
expand their geographical reach, increase their business and
treat infertile couples who could not be treated before
•
Lower cost will allow patients to go directly to INVO vs.
starting with IUI treatment ( low efficacy)
•
Offers a couple a more natural option to traditional IVF
INVO Procedure
•
During the INVO procedure fertilization and embryo development occur inside the woman’s
vaginal cavity in a disposable single use device which is called the INVOcell. (This device holds
the eggs, sperm and culture medium)
•
In the INVO procedure either mild ovarian stimulation or no ovarian stimulation are
used. Using a mild stimulation protocol, 1-10 oocytes are retrieved under light
sedation.
•
The INVOcell is then placed in the patient’s vaginal cavity for an incubation period of
3 days. After 3 days, the patient returns to the physician’s office where the
INVOcell is removed.
•
The protective outer vessel of the INVOcell is discarded and the
inner vessel is placed in INVO Bioscience’s patented Holding Block in a vertical
position for 15 minutes. The embryos can be directly viewed from the micro chamber
in the holding block by using a microscope.
•
Then the two potential best embryos are selected and loaded directly from the device with a
transfer catheter and inserted back into the women. INVO procedures may be done in a fertility
specialists office or satellite/physician center
INVO Process
INVOcell
Illustration of the INVO procedure
Advantages
Similar efficacy to IVF
• Over 800 published cases where INVO was equivalent to
IVF
Lower cost to achieve pregnancy
• Low stimulation (lower drug costs)
• No IVF overhead costs in satellite office centers
• Potentially lower embryologist costs
• INVO center equipment set –up $30,000, vs. $500,000 IVF
• No need for stable power supply and clean lab maintenance.
Advantages Cont.
Greater geographic availability
• Offers an effective fertility treatment to the world
through independent or satellite INVO centers
Greater patient involvement
• More natural incubation
Cost Per Pregnancy
Europe Based on efficacy rates/cycles/cost
• Intra-uterine insemination (IUI) =$12,000 per
pregnancy (40 % indications)
• INVO = $13,888 per pregnancy (90% of indication)
• IVF = $21,354 per pregnancy
• Cost Saving to payers and providers $7000 per
pregnancy INVO vs. IVF
Current Regulatory Status
• ISO 13485 certified and CE Mark
• FDA
• Required an IDE and clinical study
• File of 510K submission planned 3rd quarter 2010
Sales Strategy
• Physician Sales through Distributors- Current strategy in
Canada, Austria, Germany, Switzerland and Italy
• Direct Sales to Physicians and IVF centers-Current strategy in
Africa,
• INVO Centers, – Current strategy in Middle East, and Latin
America
• Strong profit margins worldwide
International Activities
INVO Centers
• TURKEY ..Initial INVO procedure performed in October 2008
• Middle East …INVO centers opening first quarter 2009 (8)
• Austria…Initial INVO procedure performed in October 2008
• Canadian approval obtained in January 2009, launch planned for
summer 2009
• In May 2009, INVO announced that the first South
American INVO Center had officially opened in Cali, Colombia, and
six existing In-Vitro Fertilization (IVF) centers located in Armenia,
Cúcuta, Bogotá, Ibagué, Medellin and Ubate, Colombia are also now
offering the INVO procedure
Distribution Agreements
Distributor
Countries
Nacer
Peru
Daxley Group
Colombia, Venezuela, Ecuador, Panama, Guatemala,
Chile and Uruguay.
Medek Medikal
Turkey, North Cyprus, Kosovo, Albania, Azerbaijan,
Uzbekistan, Bulgaria and Kazakhstan
Galaxy IVF
Pakistan (other Middle Eastern countries)
EnviMed
Thailand
PIK Progressive
Group
China, Taiwan
MediTech Ist
Canada
Current locations
17
Market Opportunity
The INVOcell and INVO process is a multi billion dollar
business if INVO Bioscience penetrates 5% of the unmet
need.
Intellectual Property
The INVOcell device was specially developed and manufactured
to optimize the ease of use and effectiveness of the procedure
at an affordable price. This product development process has
resulted in 5 active patents world wide covering the
INVOcell device, the INVO process and the Holding Block.
Funding
• INVO Biosciences has raised $1.3 M to date and is a public
company through a reverse merger as of December 5th.
• We are currently looking for $5 million in PIPE
transactions to expand the rate of launch throughout the
world and bring INVO Bioscience to break even position.
• The funds will be used to expand the sales and training
efforts of the company, to launch the product worldwide,
perform a US clinical study to obtain 510(k) clearance and
for general operations to get to profitability
2009 Forecast
Q1 2009
Revenue
Cost of
goods
Gross
Margin
$
Operating Expenses
Salaries &
Benefits
Travel
Admin
Compliance
Board
Expenses
FDA
Regulatory
Market, R&D & Facility
Total Operating Expenses
Operating
Margin
$
Headcount
Q2 2009
Q3 2009
Q4 2009
7,140 $
89,999 $
913,574
100%
1,692
14,113
50,407
63,746
129,958
14%
5,448
75,886
309,523
392,759
783,616
86%
271,117
303,457
469,483
500,860
1,544,917
169%
98,000
95,000
105,000
105,000
403,000
44%
152,166
160,499
160,499
160,499
633,663
69%
43,000
40,000
50,000
50,000
183,000
20%
6,000
134,000
384,000
384,000
908,000
99%
77,500
169,800
85,400
79,406
412,106
45%
647,783
902,756
1,254,382
1,279,765
4,084,686
447%
(944,860) $
(887,006)
$ (3,301,070)
-361%
(642,335) $
6
(826,869) $
9
359,930
12
$
456,505
2009
16
$
16
21
2010 Forecast
Q1 2010
Q2 2010
Q3 2010
Q4 2010
2010
586,989
$
747,207
$ 2,208,512 $
2,831,380
$ 6,374,088
100%
505,016
643,859
2,033,642
2,608,351
5,790,869
91%
Operating Expenses
502,915
612,500
627,500
627,500
2,370,415
37%
Salaries & Benefits
120,000
120,000
120,000
120,000
480,000
8%
Travel
212,582
212,582
212,582
212,582
850,328
13%
50,000
50,000
50,000
50,000
200,000
3%
Board Expenses
212,000
12,000
12,000
12,000
248,000
4%
FDA Regulatory
159,200
198,200
162,200
162,200
681,800
11%
1,184,282
1,184,282
4,830,543
76%
960,326
15%
Revenue
Gross Margin
$
Admin Compliance
Market, R&D & Facility
1,256,697
1,205,282
(751,681)
$
(561,423) $
Total Operating Expenses
Operating Margin
Headcount
$
18
19
849,360 $
20
1,424,069
20
$
20
22
Management Team
•
•
•
•
•
Claude Ranoux, M.D., M.S, President and Chief Scientist, has more than 30 years of experience
in the treatment of infertility; he is the inventor and developer of INVO™ procedure and
INVOcell device.
Kathleen Karloff, Chief Executive Officer has over 25 years of experience in medical device
manufacturing, clinical operations, regulatory affairs and quality systems with 13 years at Boston
Scientific and 10 years on the senior management teams of start-up organizations.
Robert Bowdring- CFO has a strong history in senior financial management with over 25 years
experience as CFO, VP Finance and Controller. Rob has been in both public and private
manufacturing and service companies during his career primarily in start up to midsize
companies.
Nancy Harrington, Vice President of Clinical Services, is an accomplished senior executive with
over twenty years of healthcare and pharmaceutical experience in reproductive health. Ms
Harrington was the Vice President of Reproductive Health Services at IVP Care providing
services to infertility patients nationwide.
Jill Wollins PhD, Regulatory Consultant, Jill Wollins, Ph.D. has more than twenty years of
experience in Global Clinical and Regulatory Affairs in the medical device and biotech
industry. She holds a Ph.D. in Biomedical Engineering and received US Regulatory Affairs
Certification (RAC) in 1999. She has worked successfully with the FDA to bring class II and III
devices to market in the US as well as obtained product approvals in the EU, Asia and the rest of
the world.
Advisory Board
•
Dr. Richard Rawlins Ph.D.: Professor and Director of In Vitro Fertilization laboratories, Rush
Center for Advanced Reproductive Care/Dept of Ob/Gyn, Rush University, Chicago, IL.
•
Dr Paul Zarutskie: Dr. Zarutskie was the Medical Director of the Fertility and Endocrine
Center of the Department of Obstetrics & Gynecology at the University of Washington. He has
also held professorships at the University of Washington and the University of Pittsburgh School
of Medicine, and has been an instructor in the Department of Obstetrics & Gynecology at
Harvard Medical School. Society. He has served as President of the Society of Assisted
Reproductive Technology (SART) and was appointed Chairman of the National Coalition of
Assisted Reproductive Technologies (NCOART).
Dr . Jake Mayer: Dr Mayer has been with the Jones Institute since 1982 . Dr. Mayer earned his
PhD in reproductive physiology at Johns Hopkins University. He has been a member of the
Executive Council of the Society for Assisted Reproductive Technologies ( SART ) since 1995
•
.
Dr. Suheil Jamil Muasher: Dr. Muasher has been Medical Director of the Jones Institute from
2001 to 2004. He is the Medical Director of The Muasher Center for Fertility and IVF. Dr.
Muasher is Clinical Professor of the Department of Obstetrics and Gynecology at George
Washington University, Associate Professor of Department of Gynecology and Obstetrics at
Johns Hopkins University School of Medicine and Professor of the Department of Obstetrics
and Gynecology at Virginia Commonwealth University.
Why Invest in INVO Bioscience, Inc. ?
INVO Bioscience’s INVOcell and INVO technology will
revolutionize the Infertility world by expanding fertility
treatment to millions of couples who are suffering from
infertility by providing:
•
•
•
•
A geographically available treatment
A cost effective treatment
A more natural treatment
A very effective treatment
Contact Information
Kathleen Karloff - CEO
INVO Bioscience Inc.
Telephone 978-878-9505
[email protected]
www.invo-bioscience.com
Investor Relations:
Tony Schor – President
Investor Awareness, Inc.
847-945-2222
www.investorawareness.com