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| 8-K - FORM 8-K - BIOLASE, INC | d421468d8k.htm |
 Fred Furry, CFO
October 4, 2012
Nasdaq: BIOL
PAGE 1
Exhibit 99.1
The BIOLASE
Total Solution |
 The BIOLASE
Total Solution
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. |
 Conventional Surgical
Devices include the scalpel, high speed drill, electrosurge, electric bone saws, and heat
generating lasers.
PAGE 3
What is Waterlase?
BIOLASE has invented an optimized a biological method to cut tissue.
Waterlase
is
a
bilogical
method
to
cut
tissue
with
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.
The BIOLASE
Total Solution
BIOLASE is Revolutionizing Surgery in Dentistry and Medicine Through the Science of Waterlase |
 •
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 our guidance 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
BIOLASE:
Company
Overview
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
reinstituted
direct sales
model; 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;
CE Mark received for EPIC 10 in final days of Q3 2012 and FDA approval received in October
2012; Entered into agreements to distribute Cefla’s New Tom CBCTs and 3Shape’s Trios
intra-oral scanner.
PAGE 5
The BIOLASE
Total Solution |
       Chart &
Financial History 1994-Aug 2006 Pignatelli
Chairman of the Board
Exclusive distribution
partnership with Henry Schein
Aug 2006–Aug 2010
Aug 2010 to present
Pignatelli Chairman of the
Board and CEO
Aug 2010
Pignatelli
Reinstated
Chairman
FDA
Clearance
Rec’d for
Waterlase
in 1998
$20
$15
$10
$5
PAGE 6
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
launched & FDA cleared EPIC 10, our 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 |
 The BIOLASE
Total Solution
Waterlase: Soft Tissue Lingual Frenectomy
PAGE 12 |
 $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.
¹
•
Over 1.2 million dentists in 134 countries and growing
rapidly
in
emerging
economies.
²
•
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
³
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
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
The BIOLASE
Total Solution |
 Current
Status:
BIOLASE
has
a
tremendous
IP
portfolio
with
over
290
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.
BIOLASE’s Extensive Patent Portfolio
Issued &
Active
Pending
Total
U.S.
81
52
133
International
81
77
158
Total
162
129
291
PAGE 16
The BIOLASE
Total Solution |
 How
Waterlase is Changing Dentistry Pain free in many 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
Waterlase
now
matches
a
high-speed
drill,
for
the
first
time
since
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 not performed with a dental drill.
High ROI:
•
Can equate to $250-$750 of additional DAILY revenue: 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 |
 Waterlase MD
™ reduced E. faecalist 2.86
times more effectively than NaOCl³
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
decontaminate
burs.
•
Only 32% of endodontic engine-driven files are replaced after
every
case
and
36%
after
every
other
case.
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.
BIOLASE’S Waterlase technology essentially eliminates the risk of cross
contamination and contagion: Eliminating the Risk of Cross Contamination
PAGE 18
The BIOLASE
Total Solution
1, 2
4
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.
1 |
 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.
New lasers:
•
February 2012: Introduced the Waterlase MDX line of all-tissue lasers with plans to continue
to offer additional complimentary all-tissue Waterlase products.
•
April 2012: Introduced the EPIC 10 soft-tissue laser. International sales initiated in
September 2012 and FDA clearance received in October 2012.
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.
PAGE 19
The BIOLASE
Total Solution
Pursuing More Opportunities to
Expand in Dentistry
|
 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
•
Growth drivers include:
•
Strong IP portfolio with additional patents pending
•
Strengthened financial situation
•
CEO’s interests aligned with stockholders
The BIOLASE
Total Solution
–
Market leader in laser dentistry
–
Significant potential market opportunities beyond core dental focus
–
Product improvements and product diversification
–
Expansion
into
new
markets,
with
small
investments
necessary
for
proof
of
concepts
(approximately $2 million)
–
Performance-based culture |