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| 8-K - FORM 8-K - BIOLASE, INC | d357615d8k.htm |
 Fred
Furry, COO & CFO NASDAQ: BLTI
www.biolase.com
PAGE
1
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.
|
 BIOLASE
is Revolutionizing Surgery in Medicine •
BIOLASE has invented and perfected a biological method to cut tissue.
•
The
energy
from
our
WaterLase
interacts
with
the
water
molecules
within
tissue.
•
The absorption of our laser energy creates an expansion and vaporization of the water
molecules within tissue causing a biological ablation with very little trauma
or bleeding. How? Through the science of WaterLase!
PAGE 3
Conventional Surgical Devices include the scalpel, high speed drill,
electrosurge, electric bone saws, and heat generating lasers.
…BIOLASE is NOT Just Another Medical Device Company!
What is Waterlase? |
 In 2011,
we implemented our turnaround as essentially a single product company:
1.
Moved from global exclusive distribution model with
Schein to direct sales and multi-distributor model.
2.
Launched iPlus which EQUALS the speed of a
traditional dental drill in Q1 2011.
3.
Introduced Biolase DaVinci digital imaging products.
4.
Grew revenues over 85% on a GAAP basis and over
98% excluding irrevocable purchase orders to
Schein and non-recurring royalty revenue.
5.
Globalized distribution with regulatory approvals in
Canada, Korea, Russia, Taiwan, & others.
6.
Expanded global sales footprint with new offices in
China & India and planned offices in UAE & Brazil.
We are moving forward to broaden our addressable
platforms and product portfolio
Becoming a Globally Diversified Platform Company
1.
Continue to diversify our revenue base to expand
addressable markets and reduce investor risk.
2.
Launched the Waterlase MDX 450 and 300 all-tissue
lasers in February 2012.
3.
Introduced the EPIC 10 soft-tissue laser in April 2012.
4.
Became the exclusive distributor for Cefla’s NewTom line
of cone beam 3D imaging products in North America.
5.
Continue our efforts in clinical development and obtaining
regulatory clearances in: ophthalmology, orthopedics, pain
management, podiatry, and aesthetics.
6.
2012 is a year for execution and
resetting investor
expectations.
PAGE 4 |
 Traditional Dentistry
The painting Cavadenti, the Tooth Puller, by Caravaggio,
circa 1608 PAGE 5 |
 BIOLASE
is 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 nearly 20,000 lasers sold worldwide, including our revolutionary iPlus, which
was launched in the first quarter of 2011:
PAGE 6
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 7
WaterLase High Speed Cutting
PAGE 7 |
 WaterLase Side by Side with Drill
PAGE
8 |
 WaterLase Soft Tissue Lingual Frenectomy
PAGE
9 |
 PAGE 10
Current Line of BIOLASE Products
Digital Imaging:
We
offer
Cefla’s
NewTom
cone
beam
3D
imaging
and
a full line of Biolase DaVinci Imaging equipment, including the D3D
cone beam as well as x-ray generators and tablets.
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, the next
generation of the very successful ezLase.
All-tissue dental lasers:
Our
all-tissue
lasers
include
our
flagship
laser,
the
revolutionary
WaterLase iPlus, and the new WaterLase MDX 450 and 300.
Medical:
Our
diode
laser
technology
offers
high
intensity
laser
therapy
in
the palm of your hand for pain management. |
 Why
Dentists Should Buy a WaterLase System? •
WaterLase technology enables traditional dentists to perform procedures that they
currently refer out to specialists or current WaterLase dentists, for
example: •
Gingivectomy = $160
•
Perio Treatment = $375
•
Hard-tissue Crown Lengthening = $520
•
Herpetic or Aphthous Ulcer = $308
•
Frenectomy = $355
•
With no anesthesia, the WaterLase also increases efficiency and allows the dentist to
work in multiple quadrants in a single visit.
•
This equates to $250-$750 per day in additional revenue. These procedures
are easy to learn and training is included in the cost..
Monthly Lease Payment
New Monthly Revenue Generated
Approx. $1,200
$5,000 –
$15,000
PAGE 11
A dentists’
return on investment can
be between ~500% and ~1,500%!
…the tremendous Return on Investment! |
 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. 5. The Bacterial
Challenge: Time to React. A call to narrow the gap between multi-drug resistant
bacteria in the EU and the development of new antibacterial agents., ECDC/EMEA Joint
Working Group, Stockholm, Sweden, September, 2009. Warning:
Patients Urged to Ask their Dentists
About the Risk of Cross Contamination!
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.
•
Sterilization techniques used for dental burs used
with
high
speed
drill
and
endodontic
files
are
not
effective. This is a serious health threat!
•
Many bacteria are becoming more and more
resistant to antibiotics.
5
PAGE 12 |
 WaterLase
MD™ reduced E. faecalis 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.
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
BIOLASE is entering a new dental category utilizing WaterLase technology as it
essentially eliminates the risk of cross contamination and contagion:
PAGE 13
Eliminating the Risk of Cross Contamination
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.
WaterLase Tips:
•
Smooth tip surface does not harbor debris or bacteria like
abrasive surface of burs or files.
•
YSGG laser energy is bacteriacidal.
3
•
Single-use, disposable tips that work without the need to
contact tissue. Also eliminates accidental sticks with
contaminated burs. |
 $50B to
$100B WaterLase Market Opportunity The
WaterLase’s
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.
•
19,000 systems in over 11,000 practices.
•
Every 1% of further 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
such as China, India, and Indonesia.
Over
19,000
systems
sold
worldwide.
1. American Dental Association. 2. World Federation of Dentistry. 3.
1998-present over 19,000 BIOLASE systems sold. PAGE 14
Our current market penetration is approximately
3% in the US and slightly less than 1% internationally!
2
1
3 |
 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
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
53
137
International
77
71
148
Total
161
124
285
PAGE 15 |
 Patented
laser toothbrush for home use: •
BIOLASE
is
currently
engaged
in
discussions
with
The
Proctor
and
Gamble
Company
(“P&G”)
to
develop
a
laser toothbrush for home use using our patents which will whiten teeth, disinfect
teeth and gums, bio- stimulate
teeth
and
gums,
relieve
pain,
and
perform
photodynamic
therapy.
New lasers:
•
BIOLASE introduced the WaterLase MDX line of all-tissue lasers in February 2012 and
plans to continue to offer additional all-tissue WaterLase products in the
future that complement the iPlus and MDX. •
We introduced the EPIC 10 soft-tissue laser in April 2012. We are currently
engineering additional and more powerful diode soft-tissue lasers for launch
in 2012 & 2013. •
We are planning to re-launch the iLase, our handheld diode laser with several new
options and applications. New Imaging products:
•
In February 2012, BIOLASE became the exclusive North American distributor for
Cefla’s NewTom cone beam 3D imaging products, thereby complementing its
large family of BIOLASE DaVinci Imaging products. Further Opportunities to
Expand in Dentistry PAGE 16 |
 Digital
Imaging Cone
Beam
Computed
Tomography
(CBCT)
3D
Imaging:
We
offer
the
Cefla
NewTom VGi and the BIOLASE DaVinci D3D digital CBCTs. These systems are a vast
improvement over traditional x-ray imaging technologies and offer tremendous
clinical and diagnostic
advantages
to
dentists.
CBCTs
allow
dentists
to
“see
more”
which,
when
coupled with our WaterLase technology, allow dentists to “do more.”
Portable
X-Ray
Tablet:
The
BIOLASE
DaVinci
iTab
x-ray
tablet
allows
for
immediate
access to x-ray images. It offers wireless synchronization to operatory
workstations. Intra-Oral
Camera:
The
BIOLASE
DaVinci
iView
is
a
progressive
scan
intra-oral
camera
that can take live and still images. This is an excellent tool to assist the
dentist in gaining patient treatment acceptance.
X-Ray
Generators:
The
BIOLASE
DaVinci
iGen
x-ray
generator
offers
a
unique
ball-joint
and brake assist for optimal positioning.
PAGE
17 |
 With our
patented WaterLase and diode technologies, we have created technological platforms
that have the ability to extend far outside of dentistry. We expect to greatly
expand our addressable markets in the near future which, we
believe, has the potential to substantially increase our revenues and stockholder
value. These potential markets represent multi-billion dollar
opportunities. Ophthalmology:
We
currently
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.
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. In 2012, we
expect approval to market
treatments
for
glaucoma
and
dry
eyes.
We
expect
approval
to
market
WaterLase
technology
for
presbyopia in the next several years.
2012: Expanding Beyond Dentistry
PAGE 18 |
 Aesthetics:
We
have
various
FDA
approvals
for
applications
in
dermatology,
plastic
surgery,
and
oculoplastics and are currently investigating options for entering these markets in
2012. 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.
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.
PAGE 19
2012:
Expanding
Beyond
Dentistry
(Continued) |
 Quarterly
Revenues
(in
Millions)
PAGE 20
2004
2005
2006
2007
2008
2009
2010
2011
2012
Q1-Mar
$ 14.5
$ 16.8
$ 16.9
$ 15.1
$ 19.0
$ 6.6
$ 4.4
$ 10.6
$ 12.3
Q2-Jun
$ 14.7
$ 14.5
$ 15.9
$ 18.2
$ 18.7
$ 14.3
$ 5.9
$ 12.1
Q3-Sep
$ 12.0
$ 11.7
$ 17.1
$ 12.8
$ 15.3
$ 12.1
$ 6.2
$ 13.1
Q4-Dec
$ 19.1
$ 19.0
$ 19.8
$ 20.8
$ 11.6
$ 10.4
$ 9.7
$ 13.1
Record quarter with
Federico Pignatelli interim
CEO during Q407
Federico Pignatelli restored
as Chairman & CEO in Aug 2010
Direct sales ramp begins in Sep 2010
Over 85% revenue
growth in 2011
compared to 2010
$-
$5.0
$10.0
$15.0
$20.0
$25.0 |
 Quarterly
Non-GAAP
Net
Income
(in
Millions)
PAGE 21
2004
2005
2006
2007
2008
2009
2010
2011
2012
Q1-Mar
$ 0.783
$ (4.015)
$ (1.462)
$ (0.890)
$ 0.985
$ (3.763)
$ (4.797)
$ 0.153
$ (0.872)
Q2-Jun
$ 1.006
$ (6.222)
$ (1.340)
$ (0.089)
$ 1.578
$ 3.020
$ (3.657)
$ 0.069
Q3-Sep
$ (0.962)
$ (4.820)
$ (0.167)
$ (2.765)
$ (3.551)
$ 1.534
$ (2.173)
$ (0.397)
Q4-Dec
$ (23.257)
$ (0.479)
$ (2.466)
$ (0.272)
$ (4.338)
$ (0.888)
$ 0.787
$ (1.260)
Adjustments from net income (loss) include: depreciation and amortization, non-cash
stock-based compensation, and interest expense. |
 Chart
& Financial History $20
$15
$10
$5
$80,000
$70,000
$60,000
$50,000
$40,000
$30,000
$20,000
$10,000
$0
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
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 |
 Federico
Pignatelli has served as our CEO since August 2010, and as our Chairman of the
Board and CEO since September 2010. Mr. Pignatelli is a >5%
shareholder and has been active in the Company as a director and various other
management roles since 1991. He also the founder of the Art & Fashion Group.
Fred Furry
has
been
our
CFO
since
November
2010
and
our
COO
since
October
2011.
He
has
20
years
of
experience specializing in the high-tech and manufacturing industries, including 18
while in public accounting. Dmitri Boutoussov
has
over
19
years
developing
laser
technologies
for
dentistry
and
medicine
in
the
U.S.
and
Europe. He joined BIOLASE in 2000 and was promoted to CTO in October 2010.
Mr. Boutoussov has authored and co-authored more than 20 U.S. and
international patents and patent applications. Bill Brown
has
more
than
30
years
of
experience
in
global/medical
device
companies.
He
has
been
with
BIOLASE
since
2002
and
was
promoted
to
VP
of
Sales
and
Marketing
in
March
2012.
Rick Whipp
joined
BIOLASE
in
July
2011
and
was
promoted
to
VP
of
Operations
in
October
2011.
Prior
to
joining BIOLASE, he spent 13 years with Discuss Dental, currently a division of Philips
Electronics. Ehab Esmail
joined
BIOLASE
in
August
2011
as
our
VP
of
Regulatory,
Clinical,
and
Quality
Affairs.
He
has
more
than 18 years of experience as a specialist in regulatory affairs in the medical device
and biologics industries. PAGE 23
Executive Management |
 BIOLASE
Today PAGE 24
•
We employ over 180 people worldwide.
•
In addition to our corporate HQ, we have sales offices in Floss
(Germany), Madrid (Spain), Shanghai (China), and Mumbai (India),
with expansion planned in Dubai (UAE), and Rio de Janero (Brazil).
•
Floss, Germany also has service and manufacturing capabilities.
•
Our primary training facilities are located in Irvine, CA.
BIOLASE Europe in Floss, Germany
•
Our 57,000 sq. ft. corporate HQ in Irvine houses finance &
administrative, sales, marketing, customer care, training,
manufacturing, and R&D. This facility can accommodate
growth to $250 million.
•
ISO 9001 certified and FDA GMP with white-room operations.
Company Headquarters in Irvine, California |