to create and deliver the new standard of care in sterile ... · this presentation shall not...
TRANSCRIPT
To Create and Deliver the New Standard of Care in Sterile Reprocessing™
Corporate Presentation | November 20181
The statements contained in this presentation and oral statements made by representatives of TSO3 Inc. (“Company”) relating to matters that are not historical facts are forward-looking statements that involve
certain risks, uncertainties and hypotheses, including, but not limited to, general business and economic conditions, the Company‘s limited history of sales or distribution, the ability of the Company to obtain the
required regulatory clearance to market its products on a worldwide basis, the outcome of patent applications, the condition of the financial markets, the ability of the Company to obtain financing on favorable
terms and other risks and uncertainties.
Risks and uncertainties about the Company’s business are more fully discussed in the disclosure materials filed with the securities regulatory authorities in Canada, which are available on SEDAR under the issuer
profile of the Company at www.sedar.com. You are urged to read these materials.
Although management of the Company believes that the conclusions, estimates or projections reflected in such forward-looking information are reasonable and represent the Company’s conclusions, estimates
or projections at this time, such information involves unknown risks and uncertainties which may cause the Company’s actual results to differ materially from the Company’s conclusions, estimates or projections
expressed or implied by such forward-looking information. You are cautioned not to place undue reliance on these forward-looking statements. Except as required by law, we do not undertake to update any
forward-looking statement.
This presentation shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of any securities, in any jurisdiction in which such offer, solicitation or sale would be unlawful.
All Dollars in USD, unless noted otherwise.
US Pats. No. 9,101,679 / 9,474,815 / 9,480,763 / 9,480,765 / 9,814,795
US Pat. Applications No. 14/820,965; 15/247,450
Canada 2,767,726 / 2,808,561
EU Pat. EP 2,601,976; EP2,609,937; EP2,482,859; EP2,601,979
Japan Pat. 5,480,975; 5,785,208; 5,785,211; 5,855,045; 6,141,950
Corresponding patents granted or pending in other countries
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Important Cautions Regarding Forward Looking Statements and Other Disclosures
STERIZONE®
registered trademarks of TSO3 Inc.
© TSO3 Inc., 2018. All rights reserved for all countries. No part of this publication may be reproduced or translated in any form or by any means, without the prior written permission of TSO3 Inc.2
To Create and Deliver
The New Standard of Care
In Sterile Reprocessing™
A Sterile Device for Every Patient
VISION. PURPOSE.
3
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One Disruptive Technology – Two Large Markets
Process/
Technology
1) The American Hospital Association, US Dept. of Health and Human Services, 2) Statistica.com 2015 3) Eurostat 4) Global Low Temperature Sterilization Market: Industry Analyst & Outlook. Koncept Analytics. January 2017
5) Centers for Disease Control and Prevention 6) US Food & Drug Administration 7) Markets and Markets, June 2016 8) Becker’s GI & Endoscopy “35 Statistics About GI/Endoscopy”
OR/CSSD$6.0B+7
GI50M+
Procedures/year8
Operating Room & Central Sterile
Supply Department
U.S. ~10,000 Hospitals & Ambulatory
Surgery Centers1
Canada ~1,400 Hospitals2
Europe ~15,000 Hospitals3
Installed base of 30,000 units4
Gastrointestinal
~15M colonoscopies performed
annually5
>500,000 ERCP Procedures
(endoscopic retrograde
cholangiopancreatographies)
performed annually6
Established Base Business Emerging Opportunity
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1. Insert Room Temperature Instruments Into a Warm Chamber
2. Create a Vacuum and Inject Small Amounts of Vapourized Heated Sterilant Over Time
3. Micro Condensation Forms on the Instruments
Breakthrough Technologies /// 138 Patents + 49 Patents Pending Worldwide
Dual SterilantsDual SterilantsDual SterilantsDual Sterilants
5
Condensation LayerCondensation LayerCondensation LayerCondensation Layer
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New Metric: Cost per Instrument Sterilized, not Cost per Cycle
Competition STERIZONE® VP4 Sterilizer
Saves up to 50% in Operating Costs
2 STERIZONE® VP4 Sterilizers = 3+ of
the Competition in Throughput
The Least Expensive Option In the
Market Today
* Actual customer results. Results may vary depending on the customer and use profile.
Proven Value Proposition*
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Disruptive Technology for OR Support
7
The STERIZONE® VP4 Sterilizer is a dual sterilant, low-temperature sterilization system
that uses vaporized hydrogen peroxide (H2O2) and ozone.
Features Advantages Benefits
• Dual Chemistry
• Dynamic Delivery
• Large Capacity
• Lowest Cost per Instrument
Sterilized
• Improved Operating and
Service Costs
• Capital Cost Avoidance
• Expandability
• Leverage Existing Hospital
Instrument Inventory
• Reduce HAI/reputational Risk
• Simple Single Cycle
Operation
• Large Loads
• Mixed Loads
• Lower Cost
• Lower Risk
• Higher Throughput
• Ability to Process Full
Instrument Sets
• Up to 1/3 fewer
machines and cycles
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“We had 4 [competitor] Sterilizers, now
we have 2 STERIZONE® VP4 Sterilizers.”
“VP4 cost less than [competitor] in long
run”
“Service Expansion: added sleep center,
ENT scopes, endoscopy reprocessing,
neurosurgeon…”
Proven Value Proposition – Independent of Customer Size
“STERIZONE® VP4 50% less cost per
instrument sterilized than
competitor”
“Decreased Number of Cycles”
STERIZONE® VP4 Sterilizer is 3 times
more efficient than competitor
1-200 Beds 600+ Beds201-600 Beds
* Based on actual 2017 customer surveys as compared to competitive low temperature hydrogen peroxide sterilizers. Results will vary depending on the customer and use profile.
Fewer Cycles Fewer Sterilizers Better Efficiency
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Capital Equipment Sales
1-4 units per facility
Higher-Margin
Proprietary Consumables
* Assuming two units installed, 10 year product life. Based on Company Estimates. For illustrative purposes only. This illustration is based on assumptions and uncertainties as well as on management’s estimate of future events. Actual
results may differ significantly from the above illustration due to promotions, customer usage patterns, outsourcing and other material variables. Not all customers enter into service contracts. The Company has limited sales and
distribution history and there is no guarantee that our sales specialists will achieve the results illustrated herein. Refer to additional risk factors contained in TSO3‘s disclosure materials filed with the securities regulatory authorities.
Service Contracts
~10% of Capital Price/year
Potential Revenue Per US Customer*
(Assuming 2 units, 10 Yr Product Life)
$200k-$300k
$20k-$30k/Sterilizer/Year
$12k-15k/Sterilizer/yr
Approx.
$0.9m-$1.2m
Revenue
Opportunity per
Customer*
Value of a Customer
“Razor”
“Razorblades”
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Commercialization Approach - CSSD
SUPPORT WITH DIRECT
SALES, CLINICAL AND
TECHNICAL PERSONNEL
LEVERAGE EARLY
ADOPTERS
• 59 sterilizers installed in
US & Canada
• <200 beds to >1,000
beds+
INCREASE MARKET
AWARENESS
• >5,000 targeted customers
• Value Proposition Selling
ESTABLISH STRONG
CUSTOMER
TARGETING METRICS
• High Use Facilities
• Heavy Orthopedic and
Robotic Surgical Centers
• Heavy Industry and
Society Presence
• >200 opportunities
As of August 8, 2018
• Trained in-house personnel
• >30 unit installation
backlog
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Sales and Marketing Activities
• Sell Direct to End Users
• Consultative Sales Approach
• Sell With Partners/Agents
• System Wide Sales
• Strategic Pricing – Lower Capital ASPs in
exchange for speed
• New Approaches
• Cost of Ownership Tools
• Digital Ads
• Trade Shows
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Commercial Activity: As of November 6, 2018
8 Sales Reps in 8 Territories – going to 11
59 Units Installed in US and Canada
90 Units Installed or Committed in NA
200 unit goal for 2019
>200 opportunities
quoted
~5,000 accounts
targets in N. America
+10 Units Committed in October 2018 Alone
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Endoscopy Sterilization – A Greenfield Opportunity
Process/
Technology
OR/CSSD$6.0B+7
GI50M+
Procedures/year8
Operating Room & Central Sterile
Supply DepartmentGastrointestinal
~15M colonoscopies performed
annually5
>500,000 ERCP Procedures
(endoscopic retrograde
cholangiopancreatographies)
performed annually6
Established Base Business Emerging Opportunity
1) The American Hospital Association, US Dept. of Health and Human Services, 2) Statistica.com 2015 3) Eurostat 4) Global Low Temperature Sterilization Market: Industry Analyst & Outlook. Koncept Analytics. January 2017
5) Centers for Disease Control and Prevention 6) US Food & Drug Administration 7) Markets and Markets, June 2016 8) Becker’s GI & Endoscopy “35 Statistics About GI/Endoscopy”
U.S. ~10,000 Hospitals & Ambulatory
Surgery Centers1
Canada ~1,400 Hospitals2
Europe ~15,000 Hospitals3
Installed base of 30,000 units4
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Technology
Advancement
Patient and Medical
Facility Demand
Regulatory
Change
• Patient Safety
• Litigation
• Cost Reduction
• STERIZONE® VP4 Sterilizer
• FDA Regulation Advancement
• Industry Dialogue and Guidelines
How Shifts Happen
= Market
Change
Market
Change
14
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Old
Modernizing GI Endoscope Reprocessing
15
“Despite reprocessing in accordance with US guidelines, viable
microbes and biologic debris persisted in clinically used [GI]
endoscopes, suggesting current reprocessing guidelines are not
sufficient to ensure successful decontamination.
“Residual contamination was detected on multiple components after
reprocessing colonoscopes and EGDs in accordance with
guidelines…viable microbes were recovered from patient-ready
endoscopes (i.e., 64% post-HLD, 9% post-storage).”
- American Journal of Infection Control (with Mayo Clinic), 2015
“Strong Evidence for Sterilization of Endoscopes
Presented at Stakeholder Meeting”
- AAMI, September 2017
Decades old processes with only incremental improvement
“In an ominous sign for patient safety, 71 percent of reusable medical
scopes deemed ready for use on patients tested positive for bacteria
at three major U.S. hospitals, according to a new study.
- American Journal of Infection Control, 2018
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TSO3 Obtains Expanded Endoscope Clearances
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Source: Olympus America Inc.
May 9, 2018 - TSO3 received FDA 510(k) clearance for the terminal sterilization of
multi-channeled flexible endoscopes using the Company’s STERIZONE® VP4
Sterilizer
• Hospitals can terminally sterilize gastrointestinal
endoscopes within the cleared intended use
• Colonoscopes, duodenoscopes and gastroscopes
STERIZONE® VP4 Sterilizer is the only terminal sterilization method that is FDA cleared to sterilize
multi-channeled flexible endoscopes (with a maximum of four channels) with inside diameters of
1.2mm or more and lengths of 1955mm or less, or 1.45mm or more and lengths of 3500mm or less.
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Recent Customer Activity
Altru Health System Improves Patient Care with Expanded Use of Cutting-Edge Sterilization
Technology
June 15, 2018 - “Being the inaugural facility to offer terminal sterilization of endoscopes using the TSO3 technology,
provides our patients with a level of safety above current best-practice standards in the industry,” says Stacie Avdem,
Director of Surgical and Procedural Services at Altru Health System.
“Altru has achieved industry leading practices with
centralization, cleaning verification, and borescope inspection in
endoscope reprocessing. The ability to sterilize endoscopes,
specifically duodenoscopes, is paramount to achieving our
mission of delivering world-class care to the residents of our
region. It shows our ongoing investment in and commitment to
patient safety,” says Jenni Gibbs, Manager of Central Sterile
Department at Altru Health System.
Next Generation TechnologyNext Generation TechnologyNext Generation TechnologyNext Generation Technology
Extensive Patent Portfolio Extensive Patent Portfolio Extensive Patent Portfolio Extensive Patent Portfolio
Razor/Razor/Razor/Razor/RazorbladeRazorbladeRazorbladeRazorblade Business ModelBusiness ModelBusiness ModelBusiness Model
FirstFirstFirstFirst----totototo----Market FDAMarket FDAMarket FDAMarket FDA----cleared Device for Terminal Sterilization of cleared Device for Terminal Sterilization of cleared Device for Terminal Sterilization of cleared Device for Terminal Sterilization of
Colonoscopes, Duodenoscopes and GastroscopesColonoscopes, Duodenoscopes and GastroscopesColonoscopes, Duodenoscopes and GastroscopesColonoscopes, Duodenoscopes and GastroscopesSUMMARYSUMMARYSUMMARYSUMMARY
Direct Commercialization StrategyDirect Commercialization StrategyDirect Commercialization StrategyDirect Commercialization Strategy
FinanciallyFinanciallyFinanciallyFinancially SoundSoundSoundSound
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Key Stats (TSX: TOS) /// All Dollars in USD, Unless Noted Otherwise
(mrq) = most recent quarter at September 30, 2018
• 2018 financial data is of September 30, 2018. On August 1, 2018, the Company closed $20 million in debt financing. See www.tso3.com 19
Stock Price (11/23/18) CAD$0.48
52 Week High-Low CAD$2.83-$0.38
Shares Outstanding (mrq) (no warrants) 93.2M
Average Daily Volume (90 day) 122,900
Market Capitalization CAD$44.8M
Institutional Holdings ~15%
Total Revenue (mrq) $0.8M
Cash and ST Investments (9/30/18) $16.1M
20