Attached files
| file | filename |
|---|---|
| 8-K - FORM 8-K - BIOLASE, INC | d411249d8k.htm |
 The
BIOLASE Total Solution
Federico Pignatelli, Chairman & CEO
September 11, 2012
Rodman & Renshaw
Annual Global Investment Conference
PAGE 1
Nasdaq: BIOL
Exhibit 99.1 |
 The
BIOLASE Total Solution
Safe Harbor Statement
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.
PAGE 2 |
 The
BIOLASE Total Solution
BIOLASE
is
Revolutionizing
Surgery
in
Dentistry
and
•
BIOLASE has invented and optimized a biological method to cut tissue
•
Waterlase is a biological method to cut tissue with very little trauma or
bleeding. •
The energy from our laser interacts with the water molecules within tissue, the
absorption of our laser energy expands and vaporizes the water molecules causing
a biological ablation with very little trauma or bleeding.
Conventional Surgical Devices include the scalpel, high speed drill,
electrosurge, electric bone saws, and heat generating lasers.
What is Waterlase?
Medicine
Through
the
Science
of
Waterlase
PAGE 3 |
 The
BIOLASE Total Solution
BIOLASE: Company Overview
•
BIOLASE is a medical technology company that develops, manufactures, and markets
dental lasers.
•
BIOLASE also markets and distributes dental imaging equipment, intra-oral scanners,
and other products designed for procedures in dentistry and medicine.
•
2011 GAAP revenue of $48.9 million, up 87% from 2010.
•
2011 Adjusted Non-GAAP revenues up 98% from 2010.
•
2012 Adjusted Non-GAAP revenue guidance of $57 to $60 million. The midpoint
of $58.5 million represents an increase of 36% from 2011, excluding equipment
sales to Henry Schein for the repayment of a liability of $5.9 million in
2011. PAGE 4 |
 The
BIOLASE Total Solution
BIOLASE: Key Milestones
1998
FDA clearance received for all-tissue Waterlase technology; began selling
Waterlase. 2004
Introduced the ezLase, our first soft-tissue diode laser.
2006
Released the Waterlase MD Turbo, a significant advance in our technology.
2006
Entered into exclusive distribution agreement with Henry Schein.
2010
Introduced the handheld, battery operated iLase soft tissue diode laser.
2011
Introduced the revolutionary Waterlase iPlus, which equaled the speed of a
high-speed dental
drill;
sales
double
from
2010
under
the
guidance
of
Federico
Pignatelli
and
the
reinstituted direct sales model; and introduced BIOLASE DaVinci Imaging
products. 2012
Final separation from Schein; introduced the Waterlase MDX line of all-tissue
lasers;
introduced the EPIC 10 soft tissue diode laser, a platform for additional diode
lasers; and
entered into agreements to distribute Cefla’s New Tom CBCTs and 3Shape’s
Trios intra-oral scanner.
PAGE 5 |
 The
BIOLASE Total Solution
PAGE 6
Chart & Financial History |
 The
BIOLASE Total Solution
Traditional Dentistry
Cavadenti, The Tooth Puller, by Caravaggio, circa
1608 PAGE 7 |
 The
BIOLASE Total Solution
BIOLASE: the World Leader in Laser Dentistry
Atraumatic
Pediatric
Tooth
Extraction
The aiming beam on
the Waterlase does
not cut the tissue or
generate any heat.
The tissue is cut
biologically, with little
or no pain, by
energizing water at
the molecular level.
…with over 20,000 lasers sold worldwide, including our revolutionary Waterlase
iPlus, which was launched in Q1 2011:
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.
PAGE 8 |
 The
BIOLASE Total Solution
Digital
Imaging:
We
offer
Cefla’s
NewTom
cone
beam
3D
imaging
and
a
full
line of BIOLASE DaVinci Imaging equipment, including the D3D CBCT.
We also distribute 3Shape’s Trios intra-oral scanning device for digital
impression-taking solutions.
Diode
soft-tissue
dental
lasers:
Our
soft
tissue
lasers
include
the revolutionary iLase, a portable diode laser with no foot
pedal, power cord, or external controls, and the newly
introduced EPIC 10 total diode solution.
Current Line of BIOLASE Products
All-tissue dental lasers:
Our all-tissue lasers include our flagship laser, the revolutionary
Waterlase iPlus, and the new Waterlase MDX 450 and 300.
PAGE 9
Medical:
Our
diode
laser
technology
offers
high
intensity
laser
therapy
in
the palm of your hand for pain management. |
 The
BIOLASE Total Solution
How It Works: Waterlase High Speed Cutting
PAGE 10 |
 The
BIOLASE Total Solution
Waterlase: Side by Side with Drill
PAGE 11 |
 The
BIOLASE Total Solution
Waterlase: Soft Tissue Lingual Frenectomy
PAGE 12 |
 The
BIOLASE Total Solution
$50B to $100B Waterlase Market Opportunity
Global market opportunity is immense…because the dental
community is the largest medical community in the world.
•
176,000 dentists in the US and Canada.
•
Over 1.2 million dentists in 134 countries and growing
rapidly in emerging economies.
•
Over 20,100 systems in over 16,000 practices.
•
Every incremental 1% of market penetration, just with the
Waterlase, is equal to an opportunity of well over $600
million in revenues
Estimated total global market of 1,200,000,
which is growing rapidly due to new markets
(e.g., China, India, and Indonesia).
Over 20,100 systems sold worldwide.
1. American Dental Association. 2. World Federation of Dentistry. 3.
1998-present over 20,100 BIOLASE systems sold. Our market penetration is
approximately 5% of dental practices in the US and approximately 1%
internationally. PAGE 13
1
2
3 |
 The
BIOLASE Total Solution
BIOLASE’s Dominant Market Position
Owning BIOLASE means owning the hard-tissue dental laser market…
80% BIOLASE
Source: BIOLASE Technology Licensing Reports
PAGE 14 |
 The
BIOLASE Total Solution
Source: iData Research Inc.
BIOLASE’s Dominant Market Position
…and the overall dental laser market.
PAGE 15
45% BIOLASE |
 Current
Status:
BIOLASE
has
a
tremendous
IP
portfolio
with
285
issued
and
pending
patents,
70%
of
which
are related to our core Waterlase (Er,Cr:YSGG) technology and medical lasers.
•
Filing and maintenance costs are closely monitored.
•
Funding for redundant patents / patents with a low-probability for issuance is
stopped. Issued &
Active
Pending
Total
U.S.
81
52
133
International
81
77
158
Total
162
129
291
PAGE 16
BIOLASE’s Extensive Patent Portfolio |
 The
BIOLASE Total Solution
How Waterlase is Changing Dentistry
•
Pain free in the majority of cases:
–
With no anesthesia, Waterlase increases efficiency and allows the dentist to work in
multiple quadrants in a single visit.
•
Less damage to the surrounding tissue.
•
Speed of the laser now matches
a high-speed drill, for the first time since the Waterlase was
introduced.
•
New standard of care:
–
Reinvigorates the dentist, their patients, and the practice.
•
Virtually eliminates the high risk of cross contamination from dental drills.
•
Increases acceptance for procedures , including those that cannot be performed with a
dental drill. •
High ROI:
–
Can
equate
to
$250-$750
of
additional
DAILY
revenue,
for
example:
a
gingivectomy
is
$160;
perio treatment is $375; hard-
tissue crown lengthening is $520; herpetic or aphthous ulcer is $308; and a frenectomy
is $355. –
Procedures are easy to learn and training is included in the cost.
PAGE 17 |
 The
BIOLASE Total Solution
BIOLASE’S Waterlase technology essentially eliminates the risk of cross
contamination and contagion: Eliminating the Risk of Cross Contamination
PAGE 18
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.
4. Dentaltown Research: Endodontics; Survey, October 2011, dentaltown.com.
Burs and Endo Files:
•
15% of “sterilized”
burs and up to 76% of “sterilized”
endodontic
files
carry
pathogenic
micro-organisms.
1,
2
•
Complex and rugged bur surface difficult to sterilize.
•
Autoclaving
fails
15%
of
the
time
to
decontaminate
burs.
1
•Only
32% of endodontic engine-driven files are replaced after
every
case
and
36%
after
every
other
case.
4
Waterlase MD™
reduced E. faecalis 2.86
times more effectively than NaOCl³
Waterlase Tips:
•
Smooth tip surface does not harbor debris or bacteria
like the abrasive surfaces of burs or files.
•
YSGG laser energy is bacteriacidal.
3
•
Single-use, disposable tips that work without the need
to contact tissue.
•Eliminates
accidental
sticks
with
contaminated
burs. |
 The
BIOLASE Total Solution
Patented laser toothbrush for home use:
•
Development underway with The Proctor and Gamble Company to develop a laser toothbrush
for home use that has the capability to whiten teeth, disinfect teeth and gums,
bio-stimulate teeth and gums, and relieve pain. This laser
toothbrush is not yet completed in its development as a potential partnership.
New lasers:
•
February 2012: Introduced the Waterlase MDX line of all-tissue lasers with plans to
continue to offer additional all-tissue Waterlase products that complement
the iPlus and MDX. •
April 2012: Introduced the EPIC 10 soft-tissue laser. Currently engineering
additional and more powerful diode soft-tissue lasers for launch in 2012
& 2013. New Imaging products:
•
February 2012: BIOLASE became the exclusive North American distributor for Cefla’s
NewTom cone beam 3D imaging products, which complements our large family of
BIOLASE DaVinci Imaging products. •
August 2012: BIOLASE became a distributor of 3Shape’s Trios intra-oral
scanning technologies. Pursuing More Opportunities to Expand
in Dentistry PAGE 19 |
 The
BIOLASE Total Solution
With our patented Waterlase and diode technologies, we have created technological
platforms
that
have
the
ability
to
extend
beyond
dentistry:
Ophthalmology:
We
hold
14
issued
and
19
pending
U.S.
and
International
patents
in
four
patent
families
in the field of ophthalmology, giving us a wide range of applications and
coverage. Capability to restore the elasticity of the eye and allow it to
return to normal function, eliminating presbyopia. We expect approval to
market our patented Waterlase technology for glaucoma, dry eyes, and presbyopia
in the next several years. 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 during 2012 and 2013.
Opportunities to Expand Beyond Dentistry
PAGE 20 |
 The
BIOLASE Total Solution
We expect to expand our addressable markets in 2012 and 2013; these potential
markets represent multi-billion dollar opportunities.
Aesthetics:
We
have
various
FDA
approvals
for
applications
in
oculoplastics,
dermatology,
and
plastic
surgery, and are currently investigating options for entering these markets in 2012 and
2013. Pain
Management:
We
anticipate
launching
a
new
deep-tissue
hand
piece
and
upgraded
diode
laser
for
pain therapy in 2012, which will coincide with a new marketing campaign. Pain
therapy works and we are seeing more high-level athletes seeking
treatment. Podiatry:
We
have
found
that
our
diode
laser
technology
is
also
very
effective
in
the
treatment
of
nail
fungus and we are completing the clinical and regulatory requirements necessary to
enter the market in late 2012/early 2013.
Opportunities to Expand Beyond Dentistry (Continued)
PAGE 21 |
 The
BIOLASE Total Solution
BIOLASE Today
Company Headquarters in Irvine, California
•
Over 190 employees worldwide.
•
Sales offices in Floss (Germany), Madrid (Spain), Shanghai
(China), and Mumbai (India), with expansion planned in Dubai
(UAE), and Rio de Janero (Brazil).
•
Floss also has service and manufacturing capabilities.
•
Our new state-of-the-art training facilities are located in Irvine,
CA. BIOLASE Europe in Floss, Germany
•
Corporate HQ in Irvine, California
•
57,000 sq. ft. facility houses finance & administrative, sales,
marketing, customer care, training, manufacturing, and R&D.
•
Can accommodate growth to $250 million.
•
ISO 9001 certified and FDA GMP with white-room operations.
PAGE 22 |
 The
BIOLASE Total Solution
Investment Considerations
PAGE 23
•
Ongoing growth in sales and core product line under new distribution model
•
Addressing $50B-100B market opportunity
–
Market leader in laser dentistry
–
Significant potential market opportunities beyond core dental focus
•
Growth drivers include:
–
Product improvements and product diversification
–
Expansion into new markets, with small investments necessary for
proof of concepts (approximately $2
million)
•
Strong IP portfolio with additional patents pending
•
Strengthened financial situation
•
CEO’s interests aligned with stockholders
–
Performance-based culture |