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NANOSONICS LIMITED AGM Information 2015

Nov 5, 2015

65405_rns_2015-11-05_32eb65e6-82cd-48a2-b71b-ba68a890eff2.pdf

AGM Information

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Nanosonics Limited 2015 Annual General Meeting

Friday 6 November 2015

Nanosonics Board, Secretaries and Auditor

Nanosonics Limited 2015 Annual General Meeting

Business of the meeting

Resolution 1 Election of a Director – Richard England

Resolution: That Richard England, who retires as a Director pursuant to the Company's Constitution and, being eligible, offers himself for re-election, be elected a Director.

Votes for : 149,465,324
Against : 2,374,563
Abstained/Excluded : 404,728
Discretion : 547,935

Resolution 2

Remuneration report

Resolution: That the Remuneration Report for the financial year ended 30 June 2015 be adopted.

Votes for : 122,175,631
Against : 3,948,462
Abstained/Excluded : 27,150,341
Discretion : 573,435

Resolution 3

Issue of Performance Rights to the CEO and President under 2015 LTIS

Resolution: That approval be given for all purposes under the Corporations Act 2001 (Cth) and the Listing Rules of ASX Limited:

a) for the issue of 206,882 Performance Rights to Mr Michael Kavanagh under the Nanosonics Employee Share Option Plan (ESOP) in respect of the 2015 LTIS; and

b) in consequence of the vesting of those Performance Rights, fully paid ordinary shares in the Company on the terms set out in the Explanatory Notes accompanying the Notice of Meeting and in accordance with the Rules of the Nanosonics ESOP (as amended from time-to-time).

Votes for : 151,076,637
Against : 836,748
Abstained/Excluded : 329,883
Discretion : 552,935

Resolution 4

Issue of Performance Rights to the President Technology Development / Commercialisation under 2015 LTIS

Resolution: That approval be given for all purposes under the Corporations Act 2001 (Cth) and the Listing Rules of ASX Limited:

a) for the issue of 70,992 Performance Rights to Dr Ronald Weinberger under the Nanosonics Employee Share Option Plan (ESOP) in respect of the 2015 LTIS; and

b) in consequence of the vesting of those Performance Rights, fully paid ordinary shares in the Company on the terms set out in the Explanatory Notes accompanying the Notice of Meeting and in accordance with the Rules of the Nanosonics ESOP (as amended from time-to-time).

Votes for : 150,898,686
Against : 796,863
Abstained/Excluded : 500,646
Discretion : 552,935

Nanosonics Limited 2015 Annual General Meeting

Chairman's Address Mr Maurie Stang

Disclaimer

This presentation is intended to provide a general outline only and is not intended to be a definitive statement on the subject matter. The information in this presentation, whether written or verbal, has been prepared without taking into account the commercial, financial or other needs of any individual or organisation. Certain information may relate to protected intellectual property rights owned by Nanosonics (the "Company"). While Nanosonics has taken due care in compiling the information, neither the Company nor its officers or advisors or any other person warrants the accuracy, reliability, completeness or timeliness of the information or guarantees the commercial or investment performance of the Company. The information does not constitute advice of any kind and should not be relied on as such. Investors must make their own independent assessment of the Company and undertake such additional enquiries as they deem necessary or appropriate for their own investment purposes. Any and all use of the information is at your own risk.

2015 – A year of significant achievement and transformation

North America grew to 5,000 in FY15, now > 5,700

Nanosonics' North American direct sales organisation now successfully implemented

Move to expanded new state of the art corporate, R&D and manufacturing

2015 – A year of significant achievement and transformation

Successful Placement and Share Purchase Plan raised \$28 million to support growth strategy

Comprehensive clinical studies program implemented supporting standard of care

R&D strategy focussing on Infection prevention. For life with powerful roadmap and pipeline in place

Strong global momentum for guidelines and regulation for prevention of Hospital Acquired Infections (HAIs)

May 2014 NEJM paper recommended increasing surveillance and prevention activities to fight HAIs

"Our nation is making progress in preventing healthcareassociated infections through three main mechanisms:

  • financial incentives to improve quality;
  • performance measures and public reporting to improve transparency; and
  • and the spreading and scaling of effective interventions.

This progress represents thousands of lives saved, prevented patient harm, and the associated reduction in costs across our nation."(1)

  1. Patrick Conway, MD, deputy administrator for innovation and quality for the Centers for Medicare & Medicaid Services (CMS), and CMS Chief Medical Officer

Governments and accrediting bodies responding to the challenge of HAIs

CMS.gov Centers for Medicare & Medicaid Services Learn about your healthcare options: Home About CMS Newsroom FAQs Archive Share Help Print
Modicare Madicald/CHP Medicare Medicaid
Coordination
Private
Insurance
francysticas
Cantar
Requiations &
Guidance
Research, Statistics,
Data & Systems
Outreach &
Education
Hospital Value Baued Purchasing Program
CONTRACTOR CONTRACTOR
Horse + Decoration + Media Referent Determine > Part Islands + 2014 Part Islands Dame + Plazal View 2015 Results for the CMS Hospital Acquired Condition Reduction Program and
Fact sheets
Rattorn to Newsmans
Fiscal Year 2015 Results for the CMS Hospital-Acquired Condition
Reduction Program and Hospital Value-Based Purchasing Program
Date
a ma
2014-12-18
Title

The Hospital-Acquired Condition (HAC) Reduction Program in the US is the result of reforms under the Affordable Care Act1

Non compliance with infection control standards associated with medical equipment & devices is one of the top 5 findings by The Joint Commission2

  1. Electronically accessed: thejointcommission.org. May 2014. Issue Two. Improperly sterilized or high-level disinfected equipment.

Risk of cross contamination with reusable devices recently reinforced

CDC/FDA Alert September 2015

Reusable medical devices must be properly maintained, cleaned and disinfected/sterilized. Healthcare facilities urged to immediately review current reprocessing practices to protect patients.

  • CRE "superbug" outbreak in the US linked to contaminated duodenoscopes in a number of healthcare facilities across the US
  • Linked to at least 13 deaths
  • FDA issued alert in March 2015 and now enforcing stricter guidelines
  • Alert on contaminated bronchoscopes also issued in September 2015

FY15 revenue and cash balance

Pleasing sales revenue achieved as North American direct sales operations established

Strong cash reserves to support growth plans

Nanosonics included in ASX 300 in March 2015

30 Jun 15 30 Jun 14 30 Jun 13
Total shares issued (million) 282.91 263.82 261.99
Share price \$1.70 \$0.79 \$0.61
Market capitalisation (million) \$481 \$208 \$159
Average daily volume (12 months) 531,000 349,000 198,000

Media coverage highlights

Comprehensive positive media coverage during the year

New state of the art global headquarters supports strategic growth objectives

Strong product development and R&D pipeline

Nanosonics well positioned to capitalise on the high growth global market for infection prevention.

  • Approximately \$5 million invested in product development and R&D activities across mechanical, electrical and software engineering, microbiology and chemistry.
  • Active engagement with global experts and societies in defining the next generation of product requirements.
  • Powerful product roadmap supporting future growth opportunities in core product and rapidly expanding market in infection prevention.

Nanosonics Limited 2015 Annual General Meeting

CEO's Address Mr Michael Kavanagh

Executive Team

McGregor Grant CFO and Company

Gerard Putt Head of Manufacturing & Operations

Michael Potas Head of RD&D

Vincent Wang Head of Global Services

Ruth Cremin Head of Quality and Regulatory

Kirste Courtney Human Resources

Andrew Murray Head of Global Marketing

Ron Bacskai President and CEO Nanosonics Inc.

Ralf Schmähling Country Manager - Germany

Julien Laronze Country Manager - France

Nanosonics' mission

We improve the safety of patients, clinics, their staff and the environment by transforming the way infection prevention practices are understood and conducted, and introducing innovative technologies that deliver improved standards of care.

Corporate objectives

Customer Experience

Establish our offerings as new standards of care globally and provide customers a convenient, seamless and consistent experience with both product and brand.

Product Innovation

Create and bring to market a portfolio of innovative and quality products that address unmet customer needs providing higher standards of safety, efficiency and patient care.

Operational Excellence

Develop an agile operation with scalable, compliant and performance focussed processes, designed to deliver a positive experience for our customers.

People Engagement

Build an organisation that attracts and retains the best people and engages and empowers them to take appropriate initiative and be accountable for our core objectives.

Value Creation

Create sustainable shareholder value, delivering high growth and strong returns , while making a significant contribution to social good.

Customer Experience – FY15 highlights

Commenced Direct Operations in North America

Expanded European Presence into 5 new countries

Grown installed base to > 5000 in US (at June 30) including adoption in many luminary sites

Implemented extensive clinical outcomes program

Supported development and adoption of new guidelines

Implemented a range of new sales tools and customer training initiatives

Implemented Service operations in US and Europe

Commenced partnerships with key associations e.g. APIC

. Establish our offerings as new standards of care globally and provide customers a convenient, seamless and consistent experience with both product and brand

Customer Experience

25

Product Innovation – FY15 highlights

Active R&D Subcommittee of Board
Engaged with key infection prevention
societies and opinion leaders
Defined Product Roadmap
Progressed our research across trophon, new
chemistries and new IP solutions
CONFIDENTIAL 

Create and bring to market a portfolio of innovative and quality products that address unmet customer needs providing higher standards of safety, efficiency and patient care.

Operational Excellence – FY15 highlights

Moved HQ, R&D center and manufacturing
operations to state of the art facility
Set up new premises in UK and Germany
Updated our IT Infrastructure
Expanded ERP system to support global
operations
Set up infrastructure to support US operations
Continued implementing LEAN principles
across the business

Develop an agile operation with scalable, compliant and performance focussed processes, designed to deliver a positive experience for our customers.

People Engagement – FY15 highlights

Engaged and aligned the organisation through mission and clarity around Corp. Objectives

Attracting top quality people to company across all disciplines

Formalised Human Capital Planning across the business

People Engagement

Build an organisation that attracts and retains the best people and engages and empowers them to take appropriate initiative and be accountable for our core objectives.

Value Creation – FY15 highlights

Create sustainable shareholder value, delivering high growth and strong returns, while making a significant contribution to social good.

FY2015 revenue and cash balance

Pleasing sales revenue achieved as North American direct sales operations established Strong cash reserves to support growth plans

FY16 Q1 Sales of \$6.46 million with cash balance of \$45.5 million

Regional Review

North American direct sales operation successfully implemented

  • Direct sales operation covering all US territories established
  • 18 highly qualified sales professionals trained and focussed on building sales pipeline
  • Warehousing, order fulfilment and direct service fully operational
  • Establishing Nanosonics as leading infection prevention brand to support trophon & introduction of future infection prevention solutions

North American adoption continues to grow strongly

  • Installed base of 5,000 units at end of FY15 now grown to 5,700 as at end Q1 FY16
  • Market opportunity of 40,000 units
  • Trophon now represented in 43 of the top 50 hospitals

Direct sales focussed across all ultrasound brands trophon now compatible with more than 900 ultrasound transducer models

  • Expanded number of ultrasound probes approved with trophon from 600 to 900
  • Covers all world's leading manufacturers
  • Includes both intracavitary and surface probes

Europe/ROW sales growing strongly

  • FY15 sales of \$2.3 million up 45% on pcp
  • UK primary driver of sales in the period with FY15 installed base ~250 units across 40 sites
  • New Welsh guidelines supporting trophon and guidelines in England and Scotland in development
  • European distribution expanded into five new countries (Austria, Belgium, Italy, Luxembourg and the Netherlands) with distribution partner, Miele Professional

Potential impact of guidelines

New NHS Wales Guidelines position automated, validated decontamination systems as the optimal solution for ultrasound probe decontamination

Wales

All Health Boards in Wales have now commenced with trophon following the introduction of guidance in 2014

Installed base pre guidance 0 Installed base post guidance 76

Approx 50% market penetration in 12 months across TV / TR departments

Scottish and English guidelines pending

HFS Survey shows everybody is using manual reprocessing methods and most with no traceability

Number of trophon units installed in Glasgow and Aberdeen in advance of guidelines

English guidelines currently under review and expect publication in "Journal of Hospital Infection" TBD

Already installations across 7 hospital settings including largest NHS trust in London

Growing interest in Ireland

HIQA - Health Information and Quality Authority driving for improved practices for Ultrasound Probe Decontamination to replace CIDEX OPA

Active program of education and support across UK

  • National Infection Prevention Society conference
  • Regional Infection Prevention Society Meetings
  • Institute of Decontamination Sciences
  • British Medical Ultrasound Society
  • Central Sterilising Club
  • British Society of Gynaecological Imaging
  • Health Facilities Scotland Decontamination Conference

European expansion with Miele

Netherlands

Education day for all ultrasound manufacturers in Germany

09:30 Uhr Begrüßungskaffee
10:00 Uhr Begrüßung
Martin Hübner, Miele Professional
10:05 Uhr Grundsätzliche Rechtsfragen zur Aufbereitung von Ultraschalls
Hans-Werner Röhlig, Amtsgericht Gladbeck
11:00 Uhr Viruswirksamkeit der Instrumentenaufbereitung unter besonde
Berücksichtigung von Ultraschallsonden
Dr. Jochen Steinmann, Dr. Brill + Partner GmbH
12:00 Uhr Mittagspause
13:00 Uhr Verfahren zur Aufbereitung von (semi-)kritischen Ultraschallso
Dr. Sebastian Werner, Ruhr-Universität Bochum
14:00 Uhr Desinfektion von transvaginalen Ultraschallsonden im klinische
Dr. Kerstin Hammer, Klinik für Frauenheilkunde, UK Münster
14:30 Uhr Aufbereitung von Ultraschallsonden aus Sicht des niedergelas
Doris Scharrel, Landesvorsitz Schleswig-Holstein, Beisitzerin i
Berufsverhand der Frauenärzte e.V.
15:00 Uhr trophon EPR - Marktstrategie und Synergieeffekte
Günter Heller, Miele Professional / Raif Schmähling, Nanosoni
15:30 Uhr Schlussdiskussion
a contract in the state of the state contract of the state

Broad market awareness and education activities

M&K April 2015 HygMed 2015

ANZ setting the benchmark for standard of care

Standard of Care – Clinical studies

HPV risk

  • Human Papilloma Virus (HPV) is associated with 99.7% of cervical cancers as well as a number of other cancers including anal, vaginal, vulvar and penile1
  • HPV Types 16 and 18 account for 5% of all cancers worldwide2

    1. Walboomers JMM,Jacobs MV,Manos MM, et al. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999; 189: 12–19.
    1. Parkin DM (2006). "The global health burden of infection-associated cancers in the year 2002". Int. J. Cancer 118 (12): 3030–44.

HPV – A real risk of cross contamination through ultrasound examination

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  • A substantial persistence of microorganisms observed on disinfected probes: HPV DNA found on 13% of samples"2
  • "HPVs are very stable viruses, able to survive on fomites and surfaces for days" 3

    1. Casalegno et. Al.: High Risk HPV Contamination of Endocavity Vaginal Ultrasound Probes: An Underestimated Route of Nosocomial Infection?, PLOS ONE, Oct 2012, Volume 7, Issue 10
    1. M'Zali et al. Persistence of microbial contamination on transvaginal ultrasound probes despite low-level disinfection procedure. PLoS One 2014;9:e93368.
    1. Ryndock EJ, Meyers C., A risk for non-sexual transmission of human papilloma virus? Expert Rev. Anti Infect. Ther. 12(10), 1165-1170 (2014).

Disinfectants commonly used on ultrasound probes do not kill HPV

Glutaraldehyde and OPA shown to be totally ineffective against natural, infectious HPV, even with longer contact times

Meyers, J., et al., Susceptibility of high-risk human papillomavirus type 16 to clinical disinfectants. J Antimicrob Chemother, 2014

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  • Second Meyers study retested OPA and also investigated ability of trophon, an automated high level disinfection system for ultrasound probes, to kill HPV
  • Results confirmed OPA to be ineffective but showed that trophon EPR totally kills natural, infectious high-risk, cancer-causing strains of HPV
  • Results presented at SHEA and APIC 2015
  • Accepted for publication in peer review Journal of Medical Virology

Ryndock E, Robison R, Meyers C. Susceptibility of HPV16 and 18 to high level disinfectants indicated for semi-critical ultrasound probes. J Medical Virology 2015. In press. 47

Strong product development and R&D pipeline

Nanosonics well positioned to capitalise on the high growth global market for infection prevention.

  • Approximately \$5 million invested in product development and R&D activities across mechanical, electrical and software engineering, microbiology and chemistry.
  • Active engagement with global experts and societies in defining the next generation of product requirements.
  • Powerful product roadmap driving future growth opportunities in core product and rapidly expanding market in infection prevention.

Business outlook

  • FY16 first quarter results encouraging during North American direct operations transition period.
  • Focus on building direct sales pipeline
  • Market fundamentals continue to strengthen
  • Increased attention by regulatory authorities
  • Supporting guidelines for automated HLD solutions
  • Excellent clinical data demonstrating superiority of trophon
  • Continuing to expand regional operations
  • North America direct operations
  • European expansion
  • Expansion into Asia Pacific
  • Strong product development and R&D pipeline