Annual and Special Meeting of the Shareholders 2015 VA_final.pdfPulmonary medicine Neurosurgery 30...
Transcript of Annual and Special Meeting of the Shareholders 2015 VA_final.pdfPulmonary medicine Neurosurgery 30...
May 6, 2015
Annual and Special Meeting of the Shareholders
Germain Carrière Chairman of the Board
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Agenda of the Meeting • Order of the day • Appointment of secretary and scrutineer • Verification of the validity of the Meeting
• Conformity of deadline of Notice • Quorum
• General Meeting • Financial Results for the period ended December 31, 2014,
by Benoît Deschamps, CFO • Appointment of Directors • Appointment of the Independent Auditors • Shareholders Rights Plan • Stock Option Plan • Other • Review of Business, by R.M. (Ric) Rumble, CEO
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May 6, 2015
Annual and Special Meeting of the Shareholders
Benoît Deschamps Chief Financial Officer
Financial Results - Period ended December 31, 2014
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Financial Highlights - Fiscal year 2014
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FISCAL YEARS
ENDED DECEMBER 31 (In thousands of $, except for per share data) 2014 2013
$ $
Revenue 433 254 Net Loss, as Reported 5,948 9,270
Adjustments for non-recurrent items R&D Tax Credits (570) (289) Write-off of assets related to the old ozone-only sterilizer 294 -
Settlement Cost - 1,864 Adjusted Net Loss 6,224 7,695 Net Loss per Share, as Reported 0.08 0.13 Net Loss per Share, as Adjusted 0.09 0.11 Average Monthly Cash Burn Rate, as Adjusted for Non-Recurrent Items (460) (626)
Highlights - Q1 2015
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FIRST QUARTER
(In thousands of $, except for per share data) 2015 2014 ACTUAL ACTUAL
Revenue 90 82 Net Loss, as Reported (1,818) (1,561)
Adjustments for non-recurrent items Write-off of Patents 214 R&D Tax Credits (35) (255) Net Adjusted Loss (1,638) (1,816) Net Loss per Share, as Reported 0.02 0.02 Net Loss per Share, as Adjusted 0.02 0.02 Average Monthly Cash Burn Rate, as Adjusted for Non-Recurrent Items (452) (550)
Retrospective since 2008
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Expenses Retrospective
(2,000,000)
-
2,000,000
4,000,000
6,000,000
8,000,000
10,000,000
12,000,000
14,000,000
2008 2009 2010 2011 2012 2013 2014
Contract Termination Cost
Financial Expenses
Administration
Marketing, Sale and Service
Supply Chain
Research and Development
R&D Tax Credits
Financial Revenues
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Revenue and Loss History
(12,000,000)
(10,000,000)
(8,000,000)
(6,000,000)
(4,000,000)
(2,000,000)
-
2,000,000
4,000,000
6,000,000
2008 2009 2010 2011 2012 2013 2014License Revenue
Sale of goods andservices
Loss
Cash Burn Rate 11
0100200300400500600700800900
1,000
Q1-
2010
Q2-
2010
Q3-
2010
Q4-
2010
Q1-
2011
Q2-
2011
Q3-
2011
Q4-
2011
Q1-
2012
Q2-
2012
Q3-
2012
Q4-
2012
Q1-
2013
Q2-
2013
Q3-
2013
Q4-
2013
Q1-
2014
Q2-
2014
Q3-
2014
Q4-
2014
Q1-
2015
Average Burn RateAdjusted for R&D Tax Credits and One-Line Items
(in Thousands of $)
Build up of working capital
Recovery of working capital
Q1-2011 to Q1-2012 – Burn rate of $734,000
Last 12 months: Burn rate of
$436,000
36 months from Q1-2011 to Q4-2013
How Long Will the Liquidities Last?
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(2,000)
-
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
LTM Burn Rate (Q2-2014 to Q1-2015)
36 months from Q1-2011 to Q4-2013
15 months from Q1-2011 to Q1-2012
0.00 $
0.50 $
1.00 $
1.50 $
2.00 $
2.50 $se
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TSO3 Closing Stock Price
2009-09-02 LOI with 3M
2009-12-29 FDA Filing and CE Mark
TSO3 Closing Stock Price 13
2010-06-09 NSE Letter
2011-06-30 Re-Submission with FDA
2012-08-02 Termination of 3M Agreement announced
2013-01-28 Clean-up 510(k) file submitted
2014-12-17 Clearance announced
Agenda of the Meeting • Order of the day • Appointment of secretary and scrutineer • Verification of the validity of the Meeting
• Conformity of deadline of Notice • Quorum
• General Meeting • Financial Results for the period ended December 31, 2014,
by Benoît Deschamps, CFO • Appointment of Directors • Appointment of the Independent Auditors • Shareholders Rights Plan • Stock Option Plan • Other • Review of Business, by R.M. (Ric) Rumble, CEO
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Appointment of Directors
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Appointment of Independent Auditors
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Me Claude Lacroix Shareholders Rights Plan
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Article 6.5 a)(version anglaise seulement)
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6.5 SUPPLEMENTS AND AMENDMENTS (a) The Company may make amendments to this Agreement from time to time to correct any clerical or typographical error or which are required to maintain the validity of this Agreement as a result of any change in any applicable legislation, rules or regulations or decision of a court or regulatory authority. The Company, at or prior to the meeting of shareholders of the Company referred to in section 6.16, may supplement or amend this Agreement without the approval of any holders of Rights or Voting Shares where the Board of Directors considers such action to be necessary or desirable (whether or not such action would materially adversely affect the interests of the holders of Rights generally).
Stock Option Plan
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Stock Option Plan
The amendment is sought:
To consider and to approve an ordinary resolution approving the replenishment of the number of common shares reserved under the Stock Option Plan by a number equal to the common shares that have been issued following the exercice of options under the Stock Option Plan and to increase of the number of common shares reserved for issuance by 2,670,427 common shares so the total number of common shares reserved for issuance of options be fixed at 8,200,000 shares.
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Agenda of the Meeting • Order of the day • Appointment of secretary and scrutineer • Verification of the validity of the Meeting
• Conformity of deadline of Notice • Quorum
• General Meeting • Financial Results for the period ended December 31, 2014,
by Benoît Deschamps, CFO • Appointment of Directors • Appointment of the Independent Auditors • Shareholders Rights Plan • Stock Option Plan • Other • Review of Business, by R.M. (Ric) Rumble, CEO
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May 6, 2015
Annual and Special Meeting of the Shareholders
R.M. (Ric) Rumble President and Chief Executive Officer
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Forward-looking Information
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The speeches made during this meeting may include forward-looking information with
respect to the Company, including its business operations, strategy, financial
performance and condition. Although management of the Corporation 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. The
listener is cautioned not to place undue reliance on these forward-looking statements.
We do not undertake to update any forward-looking statement that is contained in the
MD&A or mentioned during this meeting.
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Our Vision
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“To Create the Improved Standard in Healthcare Sterile ReprocessingTM”
Company Overview
• Founded in 1998 • Designs and Manufactures Low Temperature Sterilizers
for Medical Devices • IPO 2001 • TSX: TOS • Outstanding Shares: 82.6 M ---------------------------------------------------------------------------------------------------------------------------------------------------------
• FDA 510(k) Cleared – December 2014 • Financing Completed – March 5, 2015 • Distribution Agreement Signed: – GETINGE Infection Control – March, 2015
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What We Do
TSO3 Low Temperature Sterilization Systems offer:
Reliability Low cost Rapid turnaround Compatibility Environmentally Friendly Efficiency High Volume
Solutions for simple and complex reusable medical devices that cannot withstand other harsh sterilization modalities
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Reprocessing Areas in Hospitals 28
CSSD - STERILE GI – High Level Disinfected
Why Low Temperature Sterilization? (market drivers)
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Market Drivers 30
2001 2005 2010 2015 2020
65 yrs +
45 to 64
15 to 44
- 15 yrs
Aging Population
53% Increase
Age Impact on Demand and Type of Surgery
45 55 65 75
Percentage of procedures (average)
by age
88% of ophthalmology surgeries
70% of cardiothoracic surgeries
65% of urology surgeries
60% of general surgeries
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45 55 65 75
Open Surgery Minimally Invasive Surgery (MIS)
MIS Procedures 32
MIS
Cardiology
Gastrointestinal Urology
Gynaecology
Pulmonary medicine
Neurosurgery
30 million + surgeries in US/year
Orthopaedic
Increasingly used and finding new applications everyday
MIS Devices Complex and Delicate
MIS Devices
Require Low Temperature Sterilization
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Global Market Overview / Low Temperature Sterilization
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Capital Equipment Business
– Low Temperature Gas Sterilizers in Hospitals:
• ~30,000 installed worldwide
• Life span ~ 10 years
• Replacement business: 3,000 units/year
Total Replacement Value $4.5bln
USCanadaEuropeROW
Consumables
- Accelerating revenus due to increased placements and increased daily cycles
Worldwide Installed Base
Frost & Sullivan 2005 and TSO3 estimates
Growth Market
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• 2013-2019: from $5.13bln to $9.15bln; (CAGR @ 8.5%)
Sterilization and
Disinfection Devices
• Projected at 10.9% CAGR during the forecasted period
Low Temperature Sterilization –
Fastest Growth
Segment
Source: Transparency Market Research 2013
Regulatory: Cleared Territories STERIZONE® 125L+ Sterilizer and Accessories
• Canada • Europe • Selected APAC Countries
STERIZONE® VP4 Sterilizer with Accessories
• USA
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US Regulatory Clearance Update
STERIZONE® STERILIZATION SYSTEM
• The STERIZONE® VP4 Sterilizer (K14163)
• The STERIZONE® BI+ Biological Indicator and STERIZONE® VP4 Test Pack (K141580)
• The STERIZONE® CI+ Chemical Indicator (K141698)
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December 17, 2014 - CLEARED
Creation of a New Product Code 38
• Ethylene Oxide Gas Sterilizer Points to pre-1976 marketed device
Regulation Description
• Two or More Sterilant Sterilizer Device Classification Name
Newly Created Classification
Name
• PJJ New Product Code
Resulting in New Product
Code
STERIZONE® VP4 Sterilizer 39
STERIZONE® VP4 Sterilizer • Unique cycle intended for
rigid lumen, flex, and non-lumen devices
• Cycle comprises two phases including H2O2 injection, followed by O3 injection and dwell
Hydrogen Peroxide • 125-280 Solution™
bottle containing 280mL of 50% H2O2 solution
• Each phase can use between 7 and 20.1 mL of solution
Vaporizing technology
• Vaporizer temperature:
120°C • Vaporizes and injects
multiple and continuous pulses of a small quantity ~40 mg of 50 wt% H2O2 solution.
Other particularitie • 125 L (4.3 cu’) Chamber
Volume • Chamber temperature set to
41°C • Vented with medical grade
O2 • Separate loading rack (not
shown) • O3 generator providing a
mixture of O2 and O3 at a dose of 2 mg/L for residual H2O2 reduction
Cleared Claims
STERIZONE® VP4 Sterilizer
Retained ALL Claims within the file submitted and cleared in 2014!
• Broadest claims in industry; more devices and greater flexibility of load configurations
• Flexible, rigid, general instruments in the same load
• Largest quantity of devices in industry
• Highest gross weight available in a single load
- Supported by multiple validation loads
STERIZONE® BI+/ Test Pack
• “Demonstrated to be more resistant than the full half-cycle, including exposure to hydrogen peroxide and ozone”
• 18-hour incubation
• Shelf life of 12 months
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Throughput Defined
One load vs. three… • Mixed loads • Greater quantity • Great complexity • Reduced time • Reduced cost
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Customer Benefits
Single cycle, for all loads Ease of use / Reduction of operator error / Enhanced quality
Utilizable three shelf racks Makes the STERIZONE® VP4 Sterilizer (4.3 cu’) chamber fully usable
- Most instruments per load (Reduced operating cost/Faster turnaround)
Least load restrictions Flexible chamber content
- Efficacious throughput (Reduced time to process)
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Efficacious, Rapid, Low Cost, Compatible, High Throughput Sterilization Process
Reprocessing Areas in Hospitals 43
CSSD - STERILE GI – High Level Disinfected
Reprocessing The What to DO ... and When ...
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Spaulding Classification
Mar
gin
of s
afet
y
HIGHEST
LOWEST
Body Contact Disinfection Requirements
FDA Device Class
Intact skin Low level disinfection
Non-critical
Mucous membranes
High level disinfection
Semi-critical
Sterile body cavity
Sterilization Critical
Superbug
Antimicrobial resistance (AMR) occurs when a microbe acquires a genetic mutation making it resistant to the effect of one or more antimicrobial agents that were once effective (Source Wikipedia) Montreal hospital battles superbug CBC News Posted: Mar 01, 2010
Tricky new superbug making inroads in Canada; Montreal hospital battled outbreak by News Staff Posted Sep 19, 2011
TORONTO -- Outbreaks in two Toronto-area hospitals of a dangerous new form of superbug has infection control experts contemplating a worrisome future.
“…some CRE bacteria have become resistant to most available antibiotics. Infections with these germs are very difficult to treat, and can be deadly—one report cites they can contribute to death in up to 50% of patients who become infected.”
Centers for Disease Control (CDC) Warns CRE Infections More Common, More Resistant; Its findings, published in Vital Signs, call on states, communities, medical facility CEOs, health care providers, and patients to take steps to prevent serious infections.
CRE bacteria linked to seven infections, 2 deaths at UCLA; Posted by Staff on February 19, 2015
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Increased Importance of Technology
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Diagnostic instruments (mucous membranes) are being repurposed for use in surgical (sterile body cavity) procedures
High Level Disinfection STERILIZATION…?
Endoscopic Retrograde Cholangiopancreatography (ERCP)
Opportunity Expansion Our Data The STERIZONE® VP4 Sterilizer offers a single cycle
• Current dimensional limits in the USA are:
• 1 mm diameter by 850 mm x 3 per cycle
In Canada the STERIZONE® 125L+ Sterilizer, Cycle “3” is cleared for extended claims:
• 1 mm diameter by >3,000 mm x 24 channels per cycle
Scopes in the “News” have the following approximate dimensions:
• 4 mm by 1.25 m
TSO3 in-house data supports feasibility of pursuing enhanced claim to existing
clearance (not a new clearance) for high risk flexible endoscopes
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Potential “ERCP” Opportunity
Sterilization as a standard of practice ... IMPACT
Spill over to other scopes ???.....
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500,000 procedures annually
>1000 use locations (potential placements)
GO TO MARKET STRATEGY
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Channel Strategy
What Makes a Good Partner(s)?
Global in scope / leading regional players
Hungry: They commit their time and resources
Capable: Direct sales and service
Bundle: The ability to create “Sterilization Rooms”
STERIZONE® VP4 Sterilizer fills a “GAP” in their product portfolio: • Bolt-on product acquisition • Speed to market opportunity
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Getinge Infection Control
• UK • Germany • France • Spain • Sweden • US and Canada • Turkey • Poland • Italy • Australia • Korea • China • Hong Kong / Taiwan / Macau • Czech Republic
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Sales and Service Support • Getinge Infection Control
Associates: 3,089 Revenue: SEK 5,4 billion = USD 0.650 M Global Headquarters: Getinge, Sweden Sales Companies: 36 Manufacturing Locations: 10 Year Founded: 1904
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Compatibility 53
Case Medical, Inc.® Instrument Trays Demonstrate Enhanced Performance when used in TSO3's Superior Low-Temperature STERIZONE® Sterilization System Québec City, March 23, 2015
Instrument Trays Made of Solvay's Radel® PPSU Show Strong Compatibility with TSO3's Low-Temperature Sterilization System ANAHEIM, California; Québec (Canada), February 11, 2015
Medical Instruments Category Battery Bipolar cord Bipolar forceps Bridge Camera Defibrillator paddles and handles Doppler probe Electrocautery instrument Electrode Electrophysiology cable Electrosurgical cable Fiberoptic light cable ENT flexible endoscope Flexible bronchoscope Flexible cystoscope Flexible hysteroscope Flexible nephroscope Flexible ureteroscope Forceps Laryngoscope blade High frequency cable Lacrimal probe Laser fiber Lighted retractor Ophthalmic surgical instrument (without channel) Resectoscope and resectoscope sheath Rigid endoscope (without channel) Rigid hysteroscope Scalpel handle Semi-rigid and rigid endoscope Speculum Stopcock Temperature probe Thoracoscope Trocar and trocar sheath
Short Term Efforts
TSO3 will IMMEDIATELY…
Support initial sales and service support agreement (Getinge)
• Sales training /Service Training • Quote Support System • Collaborative Marketing Programs
Initiate Group Purchasing /Integrated delivery networks (IDN) affiliations (USA)
Build inventory to match visible short term opportunities
Accelerate MDM/OEM endorsements for their IFU’s
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In summary
FDA – Got it Financing – Did it Sales and Marketing – Started it Production – Building it Ozone Only Sterilizer – Discontinued it CRE – Not afraid of it Past – Remember it
Future – Looking forward to it
Success… – Counting on it!
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May 6, 2015
Annual and Special Meeting of the Shareholders
THANK YOU
© TSO3 Inc., 2015 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.
- STERIZONE® are registered trademarks of TSO3 Inc.
U.S. Pat. No. 6,589,479 / 7,582,257 / 7,588,720 / 7,608,217 US pat. Applications No. 12/893,742; 13/779,132; 13/779,193; 13/780,464; 13/779,168; 13/779,200; 13/780,656
Corresponding patents granted or pending in other countries Other patents pending
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