8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

September 11, 2012

Date of Report (Date of earliest event reported)

BIOLASE, INC.

(Exact name of registrant as specified in its charter)

Delaware	000-19627	87-0442441
(State of Incorporation)	(Commission File Number)	(IRS Employer Identification Number)

4 Cromwell

Irvine, California 92618

(Address of principal executive offices) (Zip Code)

(949) 361-1200

(Registrant’s telephone number, including area code)

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 7.01 Regulation FD Disclosure.

On September 11, 2012, Federico Pignatelli, Chairman and Chief Executive Officer of Biolase, Inc. (the “Company”) delivered a presentation at the Rodman & Renshaw Annual Global Investment Conference that included a written communication comprised of slides. The slides from the presentation are attached hereto as Exhibit 99.1, and are hereby incorporated by reference.

A copy of the slides will be available for viewing and download at http://www.biolase.com/investors for a period of 30 days.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

99.1 Presentation material from the Rodman & Renshaw Annual Global Investment Conference, dated September 11, 2012.

2

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	BIOLASE, INC.
Date: September 12, 2012	By:	/s/ Federico Pignatelli
		Federico Pignatelli
		Chairman and Chief Executive Officer

3

Exhibit Index

Exhibit No.	Description
99.1	Presentation material from the Rodman & Renshaw Annual Global Investment Conference, dated September 11, 2012.

4

EX-99.1

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