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

Date of Report (Date of earliest event reported): October 27, 2020

 

 

BIOLASE, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-36385   87-0442441

(State or other jurisdiction

of incorporation)

  (Commission
File Number)
  (I.R.S. Employer
Identification No.)

27042 Towne Centre Dr., Ste. 270,

Foothill Ranch, CA

  92610

(Address of principal executive offices)

 

(Zip Code)

Registrant’s telephone number, including area code: (949) 361-1200

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))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

  

Trading

symbol(s)

  

Name of each exchange

on which registered

Common Stock, par value $0.001 per share    BIOL    The Nasdaq Stock Market LLC
      (Nasdaq Capital Market)

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 

 


Item 7.01

Regulation FD Disclosure.

On October 27, 2020, Biolase, Inc. (the “Company”) filed a Current Report on Form 8-K and issued a press release announcing that it has launched a virtual investor awareness program on M-Vest.com in an effort to raise awareness and streamline business communications to shareholders and to the investment community as a whole.

Commencing on October 27, 2020, the Company has published an investor presentation to supplement previously disclosed information on the M-Vest.com platform and on the Company’s website. A copy of the presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

The information in this Current Report on Form 8-K is being furnished pursuant to Item 7.01 and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise be subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof and regardless of any general incorporation language in such filing.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.

 

99.1    Investor Presentation (furnished pursuant to Item 7.01).

 

2


SIGNATURES

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

 

    BIOLASE, INC.

Date: October 27, 2020

    By:  

/s/ Todd A. Norbe

      Todd A. Norbe
      President and Chief Executive Officer

 

3

EX-99.1

Exhibit 99.1 INVESTOR PRESENTATION NASDAQ CM: BIOL October 2020Exhibit 99.1 INVESTOR PRESENTATION NASDAQ CM: BIOL October 2020


Safe Harbor Statement Statements made in this presentation and during discussions with BIOLASE representative’s that refer to BIOLASE’s estimated or anticipated future results or other non-historical facts are forward-looking statements, as are any statements its representatives make concerning BIOLASE's strategic initiatives, anticipated financial performance and product launches. You are cautioned not to place undue reliance on these forward-looking statements, which reflect BIOLASE's current expectations and speak only as of the date of this presentation. Actual results may differ materially from BIOLASE’s current expectations depending upon a number of factors affecting BIOLASE’s business including, among others, the effects of the COVID-19 pandemic and the actions taken to contain it, adverse changes in general economic and market conditions, competitive factors, uncertainty of customer acceptance of new product offerings, risks associated with managing the growth of the business, and those other risks and uncertainties that are described, from time-to-time, in the “Risk Factors” section of BIOLASE's annual and quarterly reports filed with the Securities and Exchange Commission. BIOLASE does not undertake any responsibility to revise or update any forward-looking statements made in this presentation or during discussions with BIOLASE representatives. 2Safe Harbor Statement Statements made in this presentation and during discussions with BIOLASE representative’s that refer to BIOLASE’s estimated or anticipated future results or other non-historical facts are forward-looking statements, as are any statements its representatives make concerning BIOLASE's strategic initiatives, anticipated financial performance and product launches. You are cautioned not to place undue reliance on these forward-looking statements, which reflect BIOLASE's current expectations and speak only as of the date of this presentation. Actual results may differ materially from BIOLASE’s current expectations depending upon a number of factors affecting BIOLASE’s business including, among others, the effects of the COVID-19 pandemic and the actions taken to contain it, adverse changes in general economic and market conditions, competitive factors, uncertainty of customer acceptance of new product offerings, risks associated with managing the growth of the business, and those other risks and uncertainties that are described, from time-to-time, in the “Risk Factors” section of BIOLASE's annual and quarterly reports filed with the Securities and Exchange Commission. BIOLASE does not undertake any responsibility to revise or update any forward-looking statements made in this presentation or during discussions with BIOLASE representatives. 2


BIOLASE Overview Complete line of products for Leading global provider of dental Sold over 40,000 laser systems into general dentists, specialists and lasers for cosmetic, restorative and 80 countries to date dental practitioners surgical applications Experienced management team Established revenue base Large IP portfolio – 257 issued and effectively transitioning BIOLASE from R&D focus to commercial 43 pending patents success and profitable growth 3BIOLASE Overview Complete line of products for Leading global provider of dental Sold over 40,000 laser systems into general dentists, specialists and lasers for cosmetic, restorative and 80 countries to date dental practitioners surgical applications Experienced management team Established revenue base Large IP portfolio – 257 issued and effectively transitioning BIOLASE from R&D focus to commercial 43 pending patents success and profitable growth 3


Full-Spectrum of Laser Systems and Consumables Epic Pro™ Waterlase Express™ • Powerful and capable diode dental laser ever • Speed, comfort, and precision cutting • Small, easy to operate and cost-effective Waterlase • Leverages IPG Medical technology • Vivid HD tablet user interface • Exclusive procedural animations • Rich on-board reference library and Epic X™ Customer Care Button • Surgery, fast tooth whitening and pain therapy in one device • Ultra portable for multiple-operatory use Waterlase iPlus™ • All-Tissue dental laser- 80 FDA cleared indications Epic H™ • Replaces drill with substantial reduced need for anesthesia for teeth & bone • Designed by hygienists, for hygienists • Replaces scalpel for minimally invasive, • FDA cleared for laser bacterial reduction minimally bleeding microsurgery for soft (“LBR”) tissues 257 issued and 43 pending patents 4Full-Spectrum of Laser Systems and Consumables Epic Pro™ Waterlase Express™ • Powerful and capable diode dental laser ever • Speed, comfort, and precision cutting • Small, easy to operate and cost-effective Waterlase • Leverages IPG Medical technology • Vivid HD tablet user interface • Exclusive procedural animations • Rich on-board reference library and Epic X™ Customer Care Button • Surgery, fast tooth whitening and pain therapy in one device • Ultra portable for multiple-operatory use Waterlase iPlus™ • All-Tissue dental laser- 80 FDA cleared indications Epic H™ • Replaces drill with substantial reduced need for anesthesia for teeth & bone • Designed by hygienists, for hygienists • Replaces scalpel for minimally invasive, • FDA cleared for laser bacterial reduction minimally bleeding microsurgery for soft (“LBR”) tissues 257 issued and 43 pending patents 4


Lasers Widely Used in Medicine üMinimally invasive LASIK üLess bleeding/trauma üFaster healing üEnhanced precision üMore patient-friendly experience Training is the key driver of adoption – Waterlase Mentoring Experience (WME) Program 5Lasers Widely Used in Medicine üMinimally invasive LASIK üLess bleeding/trauma üFaster healing üEnhanced precision üMore patient-friendly experience Training is the key driver of adoption – Waterlase Mentoring Experience (WME) Program 5


COVID-19 CDC/ADA provides new guidance is well positioned to benefit!COVID-19 CDC/ADA provides new guidance is well positioned to benefit!


Aerosol Production and Contamination Risk The risk of cross contamination in the dental office is HIGH due to aerosol production 50ml/min 8ml/min Dental Drill Waterlase Dentistry 7Aerosol Production and Contamination Risk The risk of cross contamination in the dental office is HIGH due to aerosol production 50ml/min 8ml/min Dental Drill Waterlase Dentistry 7


Epic Hygiene – The right product at the right time! Sales Aid Practice Guidebook 8Epic Hygiene – The right product at the right time! Sales Aid Practice Guidebook 8


10,000+ Attendees: 3,000+ Follow-Ups Webinar series featuring the top names in dentistry, including: Dr. Low: Perio & Implantitis 2,500+ attendees 900+ follow-up requests Paula Quinn, RDH: Hygiene 1,000+ attendees 250+ follow-up requests Theresa Duncan: Reimbursement 700+ attendees Dr. Christensen: 200+ follow-up requests Post-COVID Growth 800+ attendees Dr. Luccarelli: Ortho 200+ follow-up requests 700+ attendees 300+ follow-up requests Dr. Murzyn-Danzter: Pediatrics 1,500+ attendees 350+ follow-up requests 910,000+ Attendees: 3,000+ Follow-Ups Webinar series featuring the top names in dentistry, including: Dr. Low: Perio & Implantitis 2,500+ attendees 900+ follow-up requests Paula Quinn, RDH: Hygiene 1,000+ attendees 250+ follow-up requests Theresa Duncan: Reimbursement 700+ attendees Dr. Christensen: 200+ follow-up requests Post-COVID Growth 800+ attendees Dr. Luccarelli: Ortho 200+ follow-up requests 700+ attendees 300+ follow-up requests Dr. Murzyn-Danzter: Pediatrics 1,500+ attendees 350+ follow-up requests 9


BIOLASE Partnership Program (BPP) ü Enables customers to generate revenue without any cash outflow in 2020 ü Puts money in the customers pocket now ü Write off the entire amount of purchase in 2020 without making any payments until 2021 ü When offices open, it will be critical to get patients to come back right away - Biolase provides compelling reasons to see their dentist! ü In-office training: No travel, no need to spend time away from the office, staff can participate. Facilitates true integration throughout the office. Includes ongoing personal coaching 10BIOLASE Partnership Program (BPP) ü Enables customers to generate revenue without any cash outflow in 2020 ü Puts money in the customers pocket now ü Write off the entire amount of purchase in 2020 without making any payments until 2021 ü When offices open, it will be critical to get patients to come back right away - Biolase provides compelling reasons to see their dentist! ü In-office training: No travel, no need to spend time away from the office, staff can participate. Facilitates true integration throughout the office. Includes ongoing personal coaching 10


Is targeting the right segments for growthIs targeting the right segments for growth


A Significant Growth Opportunity An estimated 60 Million people in U.S. alone have gum disease and increased health risk due to the connection between oral and systemic health Under-diagnosed, Under-treated, Peri-implantitis Stats on #s going to dentist Under-managed • Over 2.7 million implants placed 1/3 of the US Population avoids in 2017 with a 6% increase going to the dentist because of 1 each year 4 “dental anxiety or fear” • Nearly 20% of implants are considered failing after 2 years 2 (ADA 2014) • Over 500,000 implants per year in USA need attention for peri implantitis and that number 3 continues to grow • Waterlase lasers are an effective, safe solution to preserving sick implants *Source: P.I. Eke, B.A. Dye, L. Wei, G.O. Thorton-Evans, and R.J. Genco. Prevalence of Periodontitis in Adults in the United States: 2009 and 2010. J DENT RES 0022034512457373, first published on August 30, 2012 as doi:10.1177/0022034512457373 1 NIH: Trends in Dental Implant Use in the U.S., 1999–2016, and Projections to 2026 Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6854267/ 2 JADA: Failed dental implants Diagnosis, removal and survival of reimplantations Link: https://jada.ada.org/article/S0002-8177%2814%2960193-8/abstract 3 RDH: Peri-implantitis patient will end up in your chair Link: https://www.rdhmag.com/pathology/periodontitis/article/14071644/how-dental-hygienists-can-manage-periimplantitis-patients 4 DentaVox survey of 18,000 people WW – DENTAVOX: OVER 60% OF PEOPLE WORLDWIDE SUFFER FROM DENTAL FEAR Link: https://www.biospace.com/article/-dentavox-over-60-percent-of-people- worldwide-suffer-from-dental-fear-4-percent-have-never-visited-a-dentist/ 12A Significant Growth Opportunity An estimated 60 Million people in U.S. alone have gum disease and increased health risk due to the connection between oral and systemic health Under-diagnosed, Under-treated, Peri-implantitis Stats on #s going to dentist Under-managed • Over 2.7 million implants placed 1/3 of the US Population avoids in 2017 with a 6% increase going to the dentist because of 1 each year 4 “dental anxiety or fear” • Nearly 20% of implants are considered failing after 2 years 2 (ADA 2014) • Over 500,000 implants per year in USA need attention for peri implantitis and that number 3 continues to grow • Waterlase lasers are an effective, safe solution to preserving sick implants *Source: P.I. Eke, B.A. Dye, L. Wei, G.O. Thorton-Evans, and R.J. Genco. Prevalence of Periodontitis in Adults in the United States: 2009 and 2010. J DENT RES 0022034512457373, first published on August 30, 2012 as doi:10.1177/0022034512457373 1 NIH: Trends in Dental Implant Use in the U.S., 1999–2016, and Projections to 2026 Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6854267/ 2 JADA: Failed dental implants Diagnosis, removal and survival of reimplantations Link: https://jada.ada.org/article/S0002-8177%2814%2960193-8/abstract 3 RDH: Peri-implantitis patient will end up in your chair Link: https://www.rdhmag.com/pathology/periodontitis/article/14071644/how-dental-hygienists-can-manage-periimplantitis-patients 4 DentaVox survey of 18,000 people WW – DENTAVOX: OVER 60% OF PEOPLE WORLDWIDE SUFFER FROM DENTAL FEAR Link: https://www.biospace.com/article/-dentavox-over-60-percent-of-people- worldwide-suffer-from-dental-fear-4-percent-have-never-visited-a-dentist/ 12


NEW! Just Released. Minimally invasive perio protocols for the Complete Office. Waterlase Mentoring Experience Landmark Study FDA Clearance 12/19 LBR Clearance 03/20 55% Sales Closure McGuire Release 7/2020 13NEW! Just Released. Minimally invasive perio protocols for the Complete Office. Waterlase Mentoring Experience Landmark Study FDA Clearance 12/19 LBR Clearance 03/20 55% Sales Closure McGuire Release 7/2020 13


WME for the General Dentist 14WME for the General Dentist 14


Real Perio Results… Backed by Real Research New Standard of Care Protocols for Perio Excellence • The minimally invasive Waterlase REPAIR™ protocols achieve superior patient reported outcomes (less pain, swelling, bruising) and faster procedure times — with equivalent clinical results to the latest open flap techniques. • Results supported by landmark, first-of-its-kind studies JUST RELEASED! designed to meet the stringent AAP Best Evidence Consensus standard. Personalized Training for Clinicians & Staff • No travel required! In-office training by Periodontists—for Periodontists, with ongoing personal coaching, facilitates true integration throughout the office—at no charge. 15Real Perio Results… Backed by Real Research New Standard of Care Protocols for Perio Excellence • The minimally invasive Waterlase REPAIR™ protocols achieve superior patient reported outcomes (less pain, swelling, bruising) and faster procedure times — with equivalent clinical results to the latest open flap techniques. • Results supported by landmark, first-of-its-kind studies JUST RELEASED! designed to meet the stringent AAP Best Evidence Consensus standard. Personalized Training for Clinicians & Staff • No travel required! In-office training by Periodontists—for Periodontists, with ongoing personal coaching, facilitates true integration throughout the office—at no charge. 15


Opportunity Zone ENDODONTICSOpportunity Zone ENDODONTICS


® GentleWave by Sonendo Waterlase Endodontics Solving the Irrigation Problem- A Clean Canal Traditional irrigation typically does not produce the webbing between the main canals FDA clearance in 2014 u Slower procedure u Less versatile “The postop cone beams u Higher Capital cost are phenomenal” u Disposable cost $ Dr. Banchs $85M Raised by Sonendo 17® GentleWave by Sonendo Waterlase Endodontics Solving the Irrigation Problem- A Clean Canal Traditional irrigation typically does not produce the webbing between the main canals FDA clearance in 2014 u Slower procedure u Less versatile “The postop cone beams u Higher Capital cost are phenomenal” u Disposable cost $ Dr. Banchs $85M Raised by Sonendo 17


Key Drivers of Adoption “LASIK” surgery provides a good model for the potential adoption of Waterlase Education Corporate Adoption LASIK Clinical Support FDA Clearance 40+ Million Procedures (2) WW Waterlase In-Progress In-Progress In-Progress Waterlase Mentoring (1) McGuire Study Dental Service Organization Pilot Experience (”WME”) 1.000+ Office Opportunity Waterlase vs. Try before you buy with Traditional Periodontal enhanced training Therapy Over 50% success rate (1) McGuire Institute & Biolase Inc. Study - Controlled Study Comparing REPaiR® and MIST Therapies for Treatment of Periodontitis Link: https://clinicaltrials.gov/ct2/show/NCT04169139 (2) American Refractive Surgery Council: Everything You Need to Know About LASIK Eye Surgery Link: https://americanrefractivesurgerycouncil.org/everything-you-think-you-know-about-lasik- eye-surgery/ 18Key Drivers of Adoption “LASIK” surgery provides a good model for the potential adoption of Waterlase Education Corporate Adoption LASIK Clinical Support FDA Clearance 40+ Million Procedures (2) WW Waterlase In-Progress In-Progress In-Progress Waterlase Mentoring (1) McGuire Study Dental Service Organization Pilot Experience (”WME”) 1.000+ Office Opportunity Waterlase vs. Try before you buy with Traditional Periodontal enhanced training Therapy Over 50% success rate (1) McGuire Institute & Biolase Inc. Study - Controlled Study Comparing REPaiR® and MIST Therapies for Treatment of Periodontitis Link: https://clinicaltrials.gov/ct2/show/NCT04169139 (2) American Refractive Surgery Council: Everything You Need to Know About LASIK Eye Surgery Link: https://americanrefractivesurgerycouncil.org/everything-you-think-you-know-about-lasik- eye-surgery/ 18


Competitive Landscape Dental Lasers Sold 1 All Tissue Lasers Global Share Diode Lasers Global Share Global Share Elexxion AG All Tissue Sirona 6% 4% DenMat 3% Deka 5% Others 4% Deka 7% 13% ARC Laser All others J.Morita 9% 7% 22% Diodes Syneron 11% Biolase GIGAA 7% 87% 52% Biolase 24% Kavo 8% Fotona 14% AMD 14% The majority of lasers sold are Diode lasers are the Diodes. BIOLASE commands ~2/3 of our 300+ patents #3 sought-out technologies a dominant or significant related to all tissue lasers Source: Dental Compare share in both markets. 1 All tissue is hard and soft tissue Sources: iData Research 2014 reports; MarketMarkets Research 2015; industry and anecdotal reports. 19Competitive Landscape Dental Lasers Sold 1 All Tissue Lasers Global Share Diode Lasers Global Share Global Share Elexxion AG All Tissue Sirona 6% 4% DenMat 3% Deka 5% Others 4% Deka 7% 13% ARC Laser All others J.Morita 9% 7% 22% Diodes Syneron 11% Biolase GIGAA 7% 87% 52% Biolase 24% Kavo 8% Fotona 14% AMD 14% The majority of lasers sold are Diode lasers are the Diodes. BIOLASE commands ~2/3 of our 300+ patents #3 sought-out technologies a dominant or significant related to all tissue lasers Source: Dental Compare share in both markets. 1 All tissue is hard and soft tissue Sources: iData Research 2014 reports; MarketMarkets Research 2015; industry and anecdotal reports. 19


Current All Tissue Laser Market Penetration BIOLASE Opportunity 7% Every 1% increase in adoption in US = over $50M in revenue for BIOLASE Strategy to expand and grow the US Pie: 1,300 DSOs, 16% of ~5K Endodontists 200K Hygienists, ~5K Periodontists ~150K GPs Mkt, 15% CAGR 35% Mkt Adoption • Key Influencers • McGuire Landmark • WME “Training First” endorsing/promoting • *Heartland- active trial Study- JOP • Hygiene only device • Early majority segment • Waterlase Endo • Clear Choice- active trial • Histology study- JOIP • LBR clearance to • Referral “flywheel” Academy established support non-aerosol • DCA- customer • Evidence-based • Expands procedures • Virtual training positioning • Preventative Perio • Dental One- customer • ROI: 4-7 months established Treatment Protocol • Noninvasive approach • Aspen- active trial • Solves pain point • ROI: 3 months WME process= $8M/year • Revision surgery *If 30% of Heartland offices If market penetration If an additional 10% of If an additional 20% of adopted = $15M increased 5% = $70M Endos adopted = $25M Perios adopted = $50M 20Current All Tissue Laser Market Penetration BIOLASE Opportunity 7% Every 1% increase in adoption in US = over $50M in revenue for BIOLASE Strategy to expand and grow the US Pie: 1,300 DSOs, 16% of ~5K Endodontists 200K Hygienists, ~5K Periodontists ~150K GPs Mkt, 15% CAGR 35% Mkt Adoption • Key Influencers • McGuire Landmark • WME “Training First” endorsing/promoting • *Heartland- active trial Study- JOP • Hygiene only device • Early majority segment • Waterlase Endo • Clear Choice- active trial • Histology study- JOIP • LBR clearance to • Referral “flywheel” Academy established support non-aerosol • DCA- customer • Evidence-based • Expands procedures • Virtual training positioning • Preventative Perio • Dental One- customer • ROI: 4-7 months established Treatment Protocol • Noninvasive approach • Aspen- active trial • Solves pain point • ROI: 3 months WME process= $8M/year • Revision surgery *If 30% of Heartland offices If market penetration If an additional 10% of If an additional 20% of adopted = $15M increased 5% = $70M Endos adopted = $25M Perios adopted = $50M 20


THANK YOU For further information, please contact: John Beaver, EVP, CFO & COO, BIOLASE, Inc. Email: jbeaver@biolase.com Phone: 949-226-8124 NASDAQ CM: BIOLTHANK YOU For further information, please contact: John Beaver, EVP, CFO & COO, BIOLASE, Inc. Email: jbeaver@biolase.com Phone: 949-226-8124 NASDAQ CM: BIOL