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| 8-K - CURRENT REPORT ON FORM 8-K - BIOLASE, INC | d235050d8k.htm |
 BIOLASE
Technology, Inc. Federico Pignatelli, Chairman, CEO & President
UBS
13
Annual Global Life Sciences Conference
September 19-21, 2011, New York City
NASDAQ:
BLTI
www.biolase.com
th
Exhibit 99.1 |
 Safe
Harbor Statement PAGE
2
This presentation may contain forward-looking statements that are based on our
current expectations, estimates and projections about our industry as well as
management’s beliefs and assumptions. Words such as “anticipates,”
“expects,” “intends,” “plans,”
“believes,” “seeks,” “estimates,” “may,” “will,” and variations of these words or similar
expressions are intended to identify forward-looking statements. These statements
include projections about our future earnings and margins and speak only as of
the date hereof. Such statements are based upon the information available to us
now and are subject to change. We will not necessarily inform you of such changes. These statements are not
guarantees of future performance and are subject to certain risks, uncertainties and
assumptions that are difficult to predict. Therefore our actual results could
differ materially and adversely from those expressed in any forward-looking
statements as a result of various factors. The important factors which could cause
actual results to differ materially from those in the forward-looking
statements include, among others, a downturn or leveling off of demand for our
products due to the availability and pricing of competing products and technologies,
adverse international market or political conditions, a domestic economic
recession, the volume and pricing of product sales, our ability to control
costs, intellectual property disputes, the effects of natural disasters and other
events beyond our control and other factors including those detailed in
BIOLASE’s filings with the Securities and Exchange Commission including its prior
filings on Form 10-K and 10-Q. |
 Market
Data PAGE 3
As of September 15, 2011:
Share
price……………….....………………………...…………......................................................................
Shares issued and
outstanding……………………………………………..…..….….....….……………
Public float (shares held by others than the CEO and
Board).…………………..…......….………..…
Average daily volume (three month
average)…………………………………..….……………….……......
Market
capitalization……………………………………………………………...........………………..
Percentage of shares held by institutional holders (at June 30,
2011)..……..............……… Short
position………………………………………………………………………….……………………….
Dividend
yield…………………………………………………………………….…………..…….….
$3.53
30,300,000
29,000,000
590,000
$106,900,000
approximately 57%
6,952,000
4% Annual Stock
BIOLASE is currently covered by analysts from Needham & Company LLC, WJB Capital
Group, and Rodman & Renshaw LLC and is part of both the Russell Global and
Russell 2000 Indexes. |
 Financial Highlights
PAGE 4
Turnaround:
For
the
nine
month
period
ended
June
30,
2011,
BIOLASE
generated
non-GAAP
net
income
of approximately $885,000, as compared to a non-GAAP net loss of approximately $9.3
million for the nine month period ended June 30, 2010.
Insider Purchases:
During 2011, officers and directors have purchased approximately 109,700 shares of
stock in the open market for approximately $440,000. In addition, officers
and directors have converted approximately 523,000 options into shares of common
stock. Employee
Stakeholders:
BIOLASE’s
entire
executive
team
holds
options
to
purchase
common
stock.
As of June 30, 2011, approximately 82 employees held 3,000,000 options.
CEO
Stakeholder:
BIOLASE’s
Chairman,
President,
and
CEO,
Federico
Pignatelli,
has
an
annual
salary
of one dollar. Mr. Pignatelli owns approximately 1.7 million shares of stock and
200,000 options to purchase common stock. The only way that Mr. Pignatelli
will make money in 2011 is as a shareholder. |
 BIOLASE
is About Revolutionizing Surgery in Dentistry
and
Medicine
PAGE 5
New management is transforming BIOLASE from a one product, one segment company of the
past to a multi-product
and
multi-segment
platform
company
that
will
be
better
diversified
in
2012
and
beyond
and
better
positioned
for
substantial
growth
compared
to
the
“old”
BIOLASE.
In
2011,
BIOLASE
has
better
positioned itself product-wise due to the release of its revolutionary
all-tissue WaterLase iPlus, the growing interest in the iLase, a battery
operated handheld diode laser, and the introduction of a full line of digital
imaging
devices.
BIOLASE
is
also
working
diligently
to
leverage
its
revolutionary
IP
in
new
market
segments, including ophthalmology, orthopedics, dermatology, podiatry, and pain
management. We have a lower cost structure and a growing direct sales
force which will allow us to leverage our earnings compared to BIOLASE of the
past. BIOLASE
is
NOT
just
another
medical
equipment
company! |
 How
has
BIOLASE
Revolutionized
Surgery?
Years of engineering and research at BIOLASE led to the discovery that the Er,Cr:YSGG (2796nm) laser crystal (Erbium,
Chromium doped Yttrium-Scandium-Gallium-Garnet) has the highest level of absorption
in
water
molecules
contained
in
human
tissue.
This
absorption
creates
an
expansion
and
vaporization
of the water molecules causing a biological ablation of human
tissue including teeth, dentin, bone, gum, skin and the eye).
For example, tooth enamel contains up to 5% water, dentin and bone contain up to 25% water,
soft tissue (gum tissue and skin) contains up to 80% water, and the eye contains up to
90% water. …through
the
science
of
WaterLase!
PAGE 6
Conventional Surgical Devices include the scalpel, high speed drill,
electrosurge, electric bone saws, and heat generating lasers.
|
 Why
BIOLASE
WaterLase
Technology
in
Dentistry?
Traditional
high-speed
drills
work
by
FRICTION
which
creates
HEAT
which
causes
PAIN.
This
PAIN
necessitates injections of ANESTHESIA which results in PAIN and
NUMB LIPS. In
addition, the lack of feeling from the numbing injections can lead to THERMAL DAMAGE
which can lead to PULPAL DEATH and result in a ROOT CANAL.
The
traditional
high-speed
drill
also
causes
VIBRATION,
which
causes
PAIN
and
leads
to
MICROFRACTURES. These MICROFRACTURES allow BACTERIA to penetrate the tooth
which causes further DECAY and the FRACTURING of teeth.
High
speed
drills
also
require
the
use
of
BURS
which
even
after
autoclaving
have a 15% chance of carrying pathogenic micro-organisms. Needles
and files can also carry bacteria. That means in traditional dentistry the
patient has a 1 in 6 chance of cross contamination.
WaterLase energy
does not create heat or vibration so there is NO PAIN. Further, the
WaterLase is bactericidal, antiviral and essentially eliminates the risk of cross
contamination. PAGE 7 |
 Traditional Dentistry
The painting Cavadenti, the Tooth Puller, by Caravaggio, circa 1608
PAGE 8 |
 Alternative and Advanced Hi-Tech Dentistry
Atraumatic Pediatric Tooth Extraction
The aiming beam on
the NEW WaterLase
iPlus is green. This
red beam featured in
the previous
generation of
WaterLase products
does not cut the
tissue. Tissue is cut
biologically, with
water at the
molecular level.
Using BIOLASE WaterLase Systems, including our new WaterLase iPlus System:
PAGE 9
The iPlus features an
intuitive, touch-based
computer screen,
similar to a tablet
personal computer.
It is designed to
allow for remote
servicing and
software upgrades. |
 Alternative Dentistry is Less Frightening
•
There
are
160,000
dentists
currently
serving
a
population
of
300
million
Americans which means that 75 million Americans are avoiding dental care
because
of
fear.
This
equates
to
an
average
of
470
patients
per
dentist!
•
Patients spend about $1,000 per year on dental care, meaning that U.S.
dentists are missing out on an average of $470,000 of potential revenue,
every year. If a dentist that adopts painless WaterLase Technology realizes
only half of this potential, they could earn an additional $235,000 in annual
revenue by just
serving fearful patients.
PAGE 10
Using
the
dental
drill
offers
more
of
the
same
which
is
pain,
local
anesthetic,
swelling,
pain
killers,
micro-
fractures
and
cross
contamination.
WaterLase
technology
offers
a
biological
solution
with
none
of
the
downsides
of
traditional
dentistry:
NO drill, NO shot, NO pain, and NO cross contamination of bacteria or viruses.
According to the ADA, nearly 25% of all Americans avoid
dentists because they are afraid of dental drills and needles.
|
 WaterLase’s
Amazing
Return
on
Investment
•
WaterLase technology enables traditional dentists to perform procedures that
they currently refer out to specialists or WaterLase dentists, for example:
•
Gingivectomy = $160
•
Perio Treatment = $375
•
Hard-tissue Crown Lengthening = $520
•
Herpetic or Aphthous Ulcer = $308
•
Frenectomy = $355
•
This equates to $250-$750 per day in additional revenue
•
These procedures are easy to learn and training is included in the cost of the
WaterLase.
Monthly Lease Payment
New Monthly Revenue Generated
Approx. $1,000
$5,000
–
$15,000
PAGE 11
A
dentists’
return on
investment can be
between 500%
and
1,500%! |
    Technology
Supported by Scientific Data Substantial Data:
•
The effectiveness of dental
lasers is proven and well
researched.
•
Clinical data and peer-
reviewed specialty journals
substantiate the effectiveness of
laser treatment in a wide variety
of procedures.
PAGE 12 |
 Some of
the Dental Schools that are Teaching WaterLase Technology around the
World PAGE 13 |
 WaterLase High Speed Cutting
PAGE 14 |
 WaterLase vs. Drill
PAGE 15 |
 1. Dental
Health Magazine 2. Dental Burs and Endodontic Files: Are Routine Sterilization Procedures Effective?: Archie Morrison,
DDS, MS, FRCD(C); Susan Conrod, DDS JCDA •
www.cda-adc.ca/jcda •
February 2009, Vol. 75, No. 1. 3. Contaminated dental
instruments: Smith A, Dickson M, Aitken J, Bagg J.J Hosp Infect.
2002 Jul;51(3):233-5. 4. The antimicrobial efficacy of the erbium,
chromium:yttrium-scandium-gallium-garnet laser with radial emitting tips on root canal dentin walls infected with
Enterococcus faecalis: Wanda Gordon, DMD, Vahid A. Atabakhsh, DDS, Fernando Meza, DMD, Aaron
Doms, DDS, Roni Nissan, DMD, Ioana Rizoiu, MS and Roy H. Stevens, DDS, MS JADA 2007; 138(7): 992-1002.
Warning:
Patients Urged to Ask their Dentists
About the Risk of Cross Contamination!
Studies indicate that cross contamination is a huge
threat
1,2,3,4
:
•
The CDC defines cross-contamination as the act of spreading
bacteria and viruses from one surface to another. Blood-borne
viruses have the ability to live on objects and surfaces for as long
as a week.
•
Even something as innocuous as the chain and holder that fastens
a patient’s protective bib in place can contain 1,000 times more
bacteria than disposable or sterilized chains.
•
Sterilization techniques used for the dental burs used with the high
speed drill and endodontic files used in root canals are not 100%
effective. This is a serious health threat for many people.
PAGE 16 |
 Because
NO Pain, NO Tissue Damage & NO Risk of Cross-Contamination: WaterLase
MD™ reduced E. faecalis 2.86
times more effectively than NaOCl³
1. Dental Burs and Endodontic Files: Are Routine Sterilization Procedures Effective?: Archie
Morrison, DDS, MS, FRCD(C); Susan Conrod, DDS JCDA • www.cda-adc.ca/jcda
• February 2009, Vol. 75, No. 1. 2. Contaminated dental instruments:
Smith A, Dickson M, Aitken J, Bagg J.J Hosp Infect. 2002 Jul;51(3):233-5. 3. The
antimicrobial efficacy of the erbium, chromium:yttrium-scandium-gallium-garnet laser with radial emitting tips on root canal dentin walls infected with
Enterococcus faecalis: Wanda Gordon, DMD, Vahid A. Atabakhsh, DDS, Fernando Meza, DMD, Aaron
Doms, DDS, Roni Nissan, DMD, Ioana Rizoiu, MS and Roy H. Stevens, DDS, MS JADA 2007; 138(7): 992-1002
Burs and Endo Files:
•
15%
of
“sterilized”
burs
and
up
to
76%
of
“sterilized”
endodontic
files
carry
pathogenic
micro-organisms.
•
Complex and rugged bur surface difficult to
sterilize.
•
Autoclaving fails 15% of the time to completely
decontaminate burs
WaterLase Tips:
•
Smooth tip surface does not harbor debris or
bacteria like abrasive surface of burs or files.
•
YSGG laser energy is bacteriacidal.
•
Single-use, disposable tips that work without
the need to contact tissue. Also eliminates
accidental sticks with contaminated burs.
WaterLase Laser Technology Eliminates the Risk
of Cross Contamination and Contagion
PAGE 17
2
1
3
1, |
 Award
winning IP: Recognized for innovation, leadership, and the development of
numerous disruptive technologies, most notably the development of a new surgical
system to cut human tissue in a biological and atraumatic way. Received Astrum
Award at MDB Capital’s 2011 Bright Lights Conference. Strategy:
Currently working with highly regarded IP consulting company to analyze our patent
families and determine those with the greatest potential:
–
Dentistry (including new lasers for hard and soft tissue, a laser toothbrush, flavored
water) –
Ophthalmology (including procedures for presbyopia, glaucoma, maxillofacial
surgery) –
Orthopedics and pain management (including use as a general surgical knife)
Internal development, licensing, and legal action against infringers.
Intellectual Property
PAGE 18
•
•
•
• |
 Current
Status:
BIOLASE
currently
has
279
issued
and
pending
patents,
70%
of
which
are
related
to
our
core Er;Cr:YSGG technology and medical lasers.
Filing
costs
and
maintenance
are
closely
monitored.
Funding
for
redundant
patents
and
patents
with
a
low-
probability for issuance are stopped.
Patent Portfolio
Issued
Pending
Total
U.S.
84
46
130
International
74
75
149
Total
158
122
279
PAGE 19 |
 Current
Line of BIOLASE Products All-tissue
dental
lasers:
Our
all-tissue
lasers
include
our
new
flagship
laser,
the
revolutionary
WaterLase
iPlus,
and
the
WaterLase
MD
Turbo.
Diode
soft-tissue
dental
lasers:
Our
soft
tissue
lasers
include
the
ezLase
total
diode
solution,
which
offers
power
and
portability,
and
the
revolutionary
iLase,
a
portable
diode
laser
with
no
foot
pedal,
power
cord,
or
external
controls.
Medical:
The
Diolase
10
offers
high
intensity
laser
therapy
in
the
palm
of
your
hand
for
pain
management.
Digital
Imaging:
We
offer
a
full
line
of
digital
imaging
equipment,
including
cone
beam
3-D
dental
imaging
and
CAD/CAM
digital
dental
impressions.
PAGE 20 |
 Patented
laser toothbrush for Home Use •
BIOLASE is currently developing a laser toothbrush for consumer home-use in
connection with a license agreement with The Proctor and Gamble Company
(“P&G”). •
Research indicates that a laser toothbrush for home-use will whiten teeth,
disinfect teeth and gums, bio- stimulate
teeth
and
gums,
relieve
pain,
and
perform
photodynamic
therapy.
•
No other product currently on the market can perform all of these functions.
Patented flavored and sterile water
•
Flavored for patient comfort.
•
Sterile for waterline disinfection of conventional dental chair equipment and lasers.
Soft-tissue lasers
•
BIOLASE is engineering a more powerful diode soft-tissue laser that will offer the
user multiple wavelengths and power up to 40 watts.
Further Opportunities to Expand in Dentistry
PAGE 21 |
 With
our
patented
WaterLase
and
diode
technologies,
we
have
created
technological
platforms
that
have
the
ability
to
extend
far
outside
of
dentistry.
This
expansion
into
new
markets
is
a
fundamental
effort
within
BIOLASE.
We
expect
to
greatly
expand
our
addressable
markets
in
the
coming
years
which,
we
believe,
has
the
potential
to
substantially
increase
our
revenues.
Each
of
these
potential
markets
represents
a
multi-
billion
dollar
opportunity.
Ophthalmology:
We
currently
hold
13
issued
and
20
pending
U.S.
and
International
patents
in
four
patent
families
in
the
field
of
ophthalmology,
giving
us
a
wide
range
of
applications
and
coverage.
Our
patented
technology
has
the
capability
to
restore
the
elasticity
of
the
eye
and
allow
it
to
return
to
normal
function,
eliminating
presbyopia.
Management
has
established
a
new
subsidiary,
OCULASE,
which
will
own
and
develop
BIOLASE’s
ophthalmic
assets
and
technologies.
Further Opportunities to Expand in Medicine
PAGE 22 |
 Podiatry:
We
have
found
that
our
Diolase
10
technology
is
very
effective
in
the
treatment
of
nail
fungus
and
we
are
completing
the
clinical
and
regulatory
requirements
necessary
to
enter
the
market.
Orthopedics:
We
are
working
with
several
key
manufacturers
and
universities
to
provide
solutions
that
are
not
currently
available.
We
are
investigating
opportunities
for
several
orthopedic
applications
and
anticipate
filing
several
510(k)
applications
over
the
next
12
months.
Aesthetics:
We
have
various
FDA
approvals
for
applications
in
dermatology,
plastic
surgery,
and
oculoplastics
and
are
currently
investigating
options
for
entering
these
markets.
Pain
Management:
We
anticipate
launching
a
new
deep-tissue
hand
piece
and
upgraded
laser
for
pain
therapy
in
the
near
term
which
will
coincide
with
a
new
marketing
campaign.
PAGE 23
Further Opportunities to Expand in Medicine (Continued)
|
 How
BIOLASE is positioned for a successful turnaround: BIOLASE has a better
organizational structure, better cost control, and more efficient & effective management
than ever before.
The BIOLASE brand is currently known by over 80% of North American dentists and is
growing internationally. BIOLASE has the largest installed base of dental lasers
which equates to recurring revenues from consumables, warranties, and service
contracts. BIOLASE has more products available than ever before.
BIOLASE has more clinical trials, more FDA approvals, and more patents and pending
patents than ever before. Foundation for a Successful Recovery
PAGE 24
•
•
•
•
• |
 How
BIOLASE is Positioned in the Dental Market BIOLASE United
States BIOLASE International
Total: 12,500
Total: 5,500
Grand Total: 18,000
2,800
2,700
5,700
6,800
PAGE 25 |
 Owning
BIOLASE Means Owning the Hard Tissue Dental Laser Market…
Source: Biolase Technology Licensing Reports
PAGE 26
Biolase
80% |
 …and the Overall Dental Laser Market.
Biolase
45%
Source: iData Research Inc.
2009 US Dental Laser Market: Hard & Soft Tissue
PAGE 27 |
 Our
Market Opportunity in Dentistry BIOLASE’s global market opportunity is
tremendous! •
176,000
dentists
in
the
US
and
Canada.
1
•
Over
1.2
million
dentists
in
134
countries.
2
•
18,000 systems in over 11,000 practices.
•
Every 1% of further market penetration is equal to an
opportunity of well over $600 million, including
consumables.
Estimated total global market of 1,200,000,
which is growing rapidly due to new markets
such as China, India, and Indonesia.
18,000
3
systems sold worldwide.
1. American Dental Association. 2. World Federation of Dentistry. 3.
1998-present over 17,300 BIOLASE systems sold. PAGE 28
Our current market penetration is approximately
3% in the United States and slightly less than 1%
internationally! |
 Incredible Opportunity in Emerging Markets
North America
176,000 dentists
1 dentist / 1,900 population
Western Europe
240,000
dentists
1 dentist / 1,800
population
Latin America
298,000
dentists
1 dentist / 5,600 population
Eastern Europe
120,000
dentists
1 dentist / 4,000 population
Middle East
19,000
dentists
1 dentist / 3,100 population
India
35,000
dentists
1 dentist / 33,900 population
China
16,000 dentists
1 dentist / 82,300 population
Rest of Asia
43,000 dentists
1 dentist / 14,000
population
Worldwide Total
1,200,000 dentists
1. World Federation of Dentistry
Practicing Dentists
1
Japan
63,000 dentists
1 dentist / 2,000
population
PAGE 29 |
 BIOLASE
is the Global Leader in Dental Lasers: •
Over 18,000 laser systems sold to over 11,000 dental
practices in over 50 countries worldwide.
•
We have over 170 employees worldwide
•
We also have training facilities in Charlotte, NC, St.
Louis, MO, and Irvine, CA.
BIOLASE Technology, Inc. Today
Company Headquarters in Irvine, California
PAGE 30
•
We have sales offices in the U.S., Floss
(Germany), Madrid (Spain), Shanghai (China),
and Mumbai (India), with expansion planned
in Dubai (UAE), and Rio de Janero (Brazil).
BIOLASE Europe in Floss, Germany |
 Operations
•
Our 57,000 sq. ft. facility houses administrative, sales,
marketing, customer care, training, R&D and manufacturing.
Our Irvine facility can accommodate growth to $250 million.
•
We are ISO 9001 certified and FDA GMP with clean room
operations. We also have manufacturing capabilities in
Floss, Germany.
PAGE 31
•
Nearly 100% of our components and subassemblies
are manufactured in our facility and/or the U.S.
•
We have a highly skilled R&D team with extensive
medical device and laser development expertise.
We are highly focused in improving and extending
our dental and medical product portfolio.
Manufacturing and Research & Development |
 Recent
Developments Ophthalmology:
In June 2011, BIOLASE entered into an agreement with Daniel S. Durrie, M.D., an
internationally recognized refractive surgeon, to serve as BIOLASE’s primary
ophthalmic expert resource and partner
with
management
to
oversee
the
development
and
execution
of
our
clinical
studies
and
consult
on
ophthalmic
applications
for
our
intellectual
property
portfolio.
Dr.
Durrie
has
been
recognized
as
one
of
the
Top
Ten
Refractive
Surgeons
in
America
and
one
of
the
Fifty
Most
Influential
Ophthalmologists
in
the
World.
He
will
also assist with the formation of a new Advisory board for OCULASE, BIOLASE’s new
ophthalmology company, asssist in recruiting members and serve as the inaugural
chairman. Dr. Durrie agreed to options to acquire 75,000 shares of
BIOLASE’s common stock in lieu of cash compensation. Asian
Offices:
In
June
2011,
BIOLASE
officially
opened
BIOLASE
Technology
Asia
Pacific,
its
Asian
headquarters,
in
Shanghai,
China,
and
a
direct
sales
and
service
office,
BIOLASE
India
Private
Limited,
in
Mumbai, India.
Digital
Imaging
Sales:
At
the
end
of
the
second
quarter,
BIOLASE
received
its
first
orders
for
its
state
of
the
art
dental imaging devices for delivery in the third quarter.
PAGE 32 |
 Recent
Developments (continued) Legal
Settlement:
In
June
2011,
BIOLASE
reached
a
final
settlement
with
Philips
Electronics
(NYSE:PHG)
and Discus Dental LLC, regarding the litigation that Discus brought against BIOLASE in
2010 (Discus was subsequently acquired by Philips). In the litigation, Discus
asserted various claims that BIOLASE's iLase™ personal laser infringed
Discus' design patent. All of Discus' and Philips' claims against BIOLASE were
completely dropped and dismissed in their entirety with prejudice.
Direct
Sales
in
Germany:
BIOLASE
has
regained
the
ability
to
sell
direct
or
through
other
distributors
from Henry Schein Inc. (NASDAQ: HSIC) for all of its international territories and has
announced plans to expand BIOLASE Europe, GMBH, to now include a direct sales
force, along with service and support operations, for the German market.
Additions
to
the
Management
Team:
BIOLASE
has
recently
hired
Richard
Whipp
as
Director
of
Operations
and Ehab Esmail as Vice President of Global Regulatory, Quality and Clinical
Affairs. Private
Placement:
In
June
2011,
BIOLASE
raised
$9
million
from
institutional
investors
in
a
private
placement
through
the
sale
of
1.6
million
shares
of
common
stock
and
812,000
warrants.
PAGE 33 |
 0.5
1.0
Chart & Financial History
20
15
10
5
BLTI
SHARE
PRICE
1994-2006 Pignatelli
Chairman of the Board
Exclusive distribution partnership with
Henry Schein Aug 2006–Aug 2010
Aug 2010-Present
Pignatelli CEO &
Board Chairman
1998 FDA
Clearance
WaterLase
PAGE 34 |
 BIOLASE
Technology, Inc. Federico
Pignatelli,
Chairman,
CEO
&
President
UBS
13
th
Annual Global Life Sciences Conference
September 19-21, 2011, New York City
NASDAQ:
BLTI
www.biolase.com |