Research Note
RESEARCH NOTE – PATERSONS SECURITIES LIMITED 1
All information and advice is confidential and for the private information of the person to whom it is provided and is provided without any responsibility
or liability on any account whatsoever on the part of this firm or any member or employee thereof.
ANALYTICA LIMITED
COMMENCES CONSUMER LAUNCH OF PERICOACH
ALT announced in November 2014 that it had commenced the consumer
launch of PeriCoach with the device publically available in Australia and
New Zealand through its website www.pericoach.com. The direct
consumer release follows over four years of development, testing and
consultation with specialists in urogynaecology, gynaecology and pelvic
physiotherapy. The Android platform is available immediately with the
iOS platform to follow, post approval from Apple Inc. ALT now plans to
establish new sales channels including direct-to-customer sales and
arrangements with distribution partners. It has recruited a sales team for
the NSW, Queensland, Victoria / Tasmania and WA / SA regions.
CE Mark approval - ALT announced in October 2014 that it had received
CE Mark clearance for PeriCoach. This allows the device to be marketed in
Europe with only minor procedural clearances and fees required for each
European country. The Company intends to pursue these additional
approvals based on commercial priorities.
Agreement with SportsMed – ALT also announced in October 2014
that it had signed a non-binding Memorandum of Understanding (MOU)
with SportsMed Global to pursue planning for the integration of PeriCoach
with SportsMed’s athlete information system. The MOU does not yet cover
specific financial transfers between parties as there are a number of
international jurisdictions which one or both parties have yet to do
detailed pricing studies. CEO Geoff Daly indicated that he expects the
partnership to enable ALT to bring forward its development pipeline, as
well as reduce costs in duplicated effort.
September Quarter 2014 update – The Company reported a cash
balance of $0.8m at 30 September 2014 with the quarterly cash outflow
of $1.1m comprising R&D ($0.5m), staff costs ($0.4m), marketing
expenses ($0.1m) and other operating working capital ($0.2m). Following
the receipt of funds from recent capital raisings ($3.8m) and an R&D Tax
Incentive ($1.0m), we estimate that ALT currently has cash on hand of
$4.7m. At the current monthly cash burn rate of c$0.4m, this provides
sufficient funding for the Company until at least the end of FY2015. By
this time ALT expects to be generating revenue from PeriCoach sales in
Australia, the US and Europe.
PeriCoach revenue model – The Company intends to sell PeriCoach on
a 12-month contract for $298 which includes the device, App and cloud
data storage. Based on our estimates, it needs to sell c20,000 PeriCoach
devices to cover its fixed cost base (or c1,700 devices per month). We
note that ALT’s fixed cost base has increased to c$4.2m pa (from c$1.5m
pa in prior years) now that it has entered full marketing mode.
Potential Catalysts
• Commencing global launch
• Encouraging demand indications
• Global mobile health uptake trend
• Potential corporate action
Key Risks
• General medical device operating risks include maintaining rights to
technology and patents; complex government health regulations; the
actions of direct and indirect competitors; market acceptance; loss of
key personnel; potential product liability; operational issues; and
additional capital requirements.
24 November 2014
RIC: ALT.AX BBG: ALT AU
Price: A$ 0.03
Shares o/s m 939.2
Free Float % 80.0
Market Cap. A$m 25.4
Net Cash A$m 4.7
52wk High/Low A$ 0.05/0.02
PeriCoach Indicative Timeline
4Q 2014 PeriCoach full launch in Australia
4Q 2014 FDA regulatory submission (US)
2Q 2015 PeriCoach approval in the US
Analyst: Ben Kakoschke
Phone: (+61 3) 9242 4181
Email: [email protected]
Disclosure:
Patersons Securities Ltd acted as Lead Manager to Share Placements that raised $1.2m and a Rights Issue that raised $2.6m at 3.0 cents per share for Analytica Ltd in October 2014. It also acted as Lead Manager to a Share Placement that raised $1.8m and Rights Issue that raised $1.2m at 2.4 cents per share for Analytica Ltd in May 2014; and Underwriter to a Share Purchase Plan that raised $1.8m at 1.7 cents per share for Analytica Ltd in September 2013. It was paid fees for these services. The preparation of this report was partially funded by the Company in accordance with the terms of an agreement with Patersons Securities Ltd. This report was prepared solely by Patersons and not by the Company.
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24 November 2014 Analytica Limited
RESEARCH NOTE – PATERSONS SECURITIES LIMITED 2
All information and advice is confidential and for the private information of the person to whom it is provided and is provided without any responsibility
or liability on any account whatsoever on the part of this firm or any member or employee thereof.
COMPANY UPDATE
Commences Consumer Launch of PeriCoach
ALT announced in November 2014 that it had commenced the consumer launch of PeriCoach with the
device publically available in Australia and New Zealand through its website www.pericoach.com. The
release follows over four years of development, testing and consultation with specialists in
urogynaecology, gynaecology and pelvic physiotherapy. The Android platform is available immediately
with the iOS platform to follow, post approval from Apple Inc. The iOS platform is currently under
review by Apple Inc. and approval is required to make the PeriCoach App available for download (the
hardware is the same for both platforms). ALT now plans to establish new sales channels including
direct-to-customer sales and arrangements with distribution partners. It has recruited a sales team
for the NSW, Queensland, Victoria / Tasmania and WA / SA regions.
CE Mark Approval for PeriCoach
ALT announced in October 2014 that it had received CE Mark clearance for PeriCoach. This allows the
device to be marketed in Europe with only minor procedural clearances and fees required for each
European country. The Company intends to pursue these additional approvals based on commercial
priorities. We note that CE Mark certification is also recognised by many non-European medical device
regulatory jurisdictions, expediting marketing approvals in those countries.
Agreement with Sportsmed Global
ALT also announced in October 2014 that it had signed a non-binding Memorandum of Understanding
(MOU) with SportsMed Global to pursue planning for the integration of PeriCoach with SportsMed’s
system. The MOU does not yet cover specific financial transfers between parties as there are a
number of international jurisdictions which one or both parties have yet to do detailed pricing studies.
ALT indicated that a future product in the PeriCoach product development pipeline could involve the
combination of pelvic floor exercise data with other factors influencing the pelvic floor such as injury,
nutrition, medication, maternal history, as well as overall health and fitness. The Company expects a
partnership with SportsMed to accelerate the development of the PeriCoach cross-functional data
analysis system. CEO Geoff Daly indicated that the SportsMed software functionality is where ALT
aimed to be in 12 months and it would have taken ALT at least two years to develop SportsMed’s
international health and fitness market expertise. He expects the partnership to enable ALT to bring
forward its development pipeline, as well as reduce costs in duplicated effort.
Capital Raising
During October and November 2014, the Company raised $3.8m in equity through Share Placements
($1.2m) and a Rights Issue ($2.6m) priced at 3.0 cents per share. ALT indicated that the funds would
be used to fund marketing costs in connection with the launch of PeriCoach as well as general
working capital expenses. CEO Geoff Daly commented that the capital raising enables ALT to
accelerate sales and marketing opportunities and shareholders should expect to see and hear more
about the product in mainstream media over the coming months.
We note that, as previously flagged, ALT also received a $1.0m Research and Development Tax
Incentive relating to the financial year to 30 June 2014. The cash tax incentive is an initiative of the
Federal Government to assist small companies to invest in essential R&D to be internationally
competitive with new innovative products. ALT indicated that the funds will also be applied to the
advancement and roll-out of PeriCoach.
The Company reported a cash balance of $0.8m at 30 September 2014 with the quarterly cash
outflow of $1.1m comprising R&D ($0.5m), staff costs ($0.4m), marketing expenses ($0.1m) and
other operating working capital ($0.2m). Following the receipt of funds from recent capital raisings
($3.8m) and an R&D Tax Incentive ($1.0m), we estimate that ALT currently has cash on hand of
$4.7m. At the current monthly cash burn rate of c$0.4m, this provides sufficient funding for the
Company until at least the end of FY2015.
Clinical Trial
ALT announced that it has completed the design of its Clinical Trial for PeriCoach. Pending ethics
committee clearances, the study aims to use 100 participants at up to 10 sites in Australia, with
evaluations conducted at baseline, device training and implementation, 2 weeks, 4 weeks, 8 weeks,
12 weeks, 16 weeks, and 20 weeks post initial usage of PeriCoach. The study is not required for any
regulatory approvals and is being undertaken to provide clinicians and other partners with formal
evidence of the system’s efficacy.
24 November 2014 Analytica Limited
RESEARCH NOTE – PATERSONS SECURITIES LIMITED 3
All information and advice is confidential and for the private information of the person to whom it is provided and is provided without any responsibility
or liability on any account whatsoever on the part of this firm or any member or employee thereof.
ABOUT ANALYTICA LIMITED
Company Overview
Analytica Limited (ALT) is a developer and marketer of medical devices, with lead product PeriCoach
commencing a consumer product launch in November 2014. PeriCoach provides a mobile health
solution for the 1 in 3 women globally who suffer Stress Urinary Incontinence (SUI). The Company is
also commercialising its AutoStart Infusion System which is an FDA-approved burette with improved
safety and cost reduction features. A summary of ALT’s key products is illustrated in Figure 1.
PeriCoach comprises a consumer-level device, smartphone App, web portal and discreet case for
recharging and storage. The device works by evaluating muscle force in the pelvic floor muscles
(pubococcygeus and puborectalis) and transmitting the information to a smartphone. From there it
can be uploaded to a cloud-based portal, which enables remote access by clinicians as well as an
efficient way to deliver future software updates. Readings are typically taken in 2 minute sessions
comprising exercise and rest phases. This unique system enables clinicians, for the first time, to
remotely determine if a woman suffering SUI is correctly performing pelvic floor exercises, showing
improvement, or whether other possible causes need to be explored. ALT commenced a controlled
market release of PeriCoach in June 2014 and a direct consumer product launch in Australia and New
Zealand during November 2014. The Company is also planning to launch PeriCoach in the US and
Europe in 2015 once the required approvals have been received.
Initial electronics assembly and testing is conducted by a Melbourne electronics contract manufacturer
followed by shipping to a Sydney contract moulding manufacturer for final assembly and testing. Most
of the parts are standard electronic components with the exception of the batteries and proprietary
designed sensors which are sourced offshore and therefore require a longer ordering lead-time. The
unique force sensor arrangement is covered by patents in key global markets Australia, the US,
China, Brazil, Japan, India and Europe. Design Registration and Trademarks have also been obtained
in the same jurisdictions. We also note that ALT commenced development of PeriCoach in 2009 and
has spent c$3m on R&D and clinical trials to establish its proprietary database and App. The long
lead-times involved in generating sufficient clinical data and gaining regulatory approvals provides an
additional barrier to entry for potential competitors.
ALT intends to sell PeriCoach on a 12-month contract for $298 which includes the device, App and
cloud data storage. While the device cost has not been disclosed, we estimate it at c$90 per unit
given the lower initial production volumes and onshore assembly. We also note that the Company’s
fixed cost base has increased to c$4.2m pa (from c$1.5m pa in prior years) now that it has entered
full marketing mode. Under this assumption, ALT must sell c20,000 PeriCoach devices to cover its
fixed cost base or c1,700 devices per month.
Figure 1: Analytica’s key products
Source: Analytica and Patersons Securities
24 November 2014 Analytica Limited
RESEARCH NOTE – PATERSONS SECURITIES LIMITED 4
All information and advice is confidential and for the private information of the person to whom it is provided and is provided without any responsibility
or liability on any account whatsoever on the part of this firm or any member or employee thereof.
Market Opportunity
Global Incontinence Market
SUI is usually caused by trauma to the pelvic floor muscles during pregnancy, childbirth and
menopause. It affects 1 in 3 women worldwide which gives ALT a target market of 3m women in
Australia alone (1 in 3 of the 9m women in Australia aged over 15). The significant market
opportunity is also demonstrated by the size of the US incontinence pad market, which was valued at
$5.3bn in 2012 and is estimated to reach over $7.0bn by 2017.
ALT is also specifically targeting pre-pregnancy women aged between 20 - 40 years to assist in
strengthening muscles prior to childbirth, when pelvic floor damage is most likely to occur, and in
repairing muscles post childbirth. We note that the Australian Bureau of Statistics recorded 0.3m new
babies in 2012, which means around 0.3m mothers-to-be are being advised of the benefits of pelvic
floor exercises in preventing incontinence.
PeriCoach is a patient-driven solution targeting a market with a significant unmet need and a costly
load on the public system. It is a data-centric product with data aggregated from the first patient
onwards able to be used to mine clinical evidence for reimbursement, product enhancements and
clinical studies. An independent reimbursement report commissioned by ALT verified that US health
funds will reimburse for the costs of visits to a clinician for patients using the PeriCoach. In addition,
Australian Medicare recognises SUI as a chronic condition with reimbursement of clinician treatment
costs. We believe this reimbursement provides support for ALT’s clinician-centric marketing strategy.
Existing Monitoring Devices
A Kegel perineometer is an instrument for measuring the strength of voluntary contractions of the
pelvic floor muscles using an air pressure sensor. Figure 2 illustrates a personal perineometer (price
c$200) which is recommended by clinicians for home use to help women to monitor pelvic floor
exercises by measuring muscle strength. Figure 2 also illustrates a clinical perineometer (price
c$1,300) which enables clinicians to assess muscle strength and teach pelvic floor exercises with a
hand-held device. An electromyography perineometer can also be used to provide a clinical diagnosis
by measuring electrical activity in the pelvic floor muscles.
Figure 2: Personal and clinical perineometers Figure 3: Elvie mobile health device (development stage)
Source: cardiodesign.com.au Source: elvie.com
Performing exercises to strengthen pelvic floor muscles is acknowledged as the most effective
frontline treatment for SUI. The best results are achieved with a clinician’s training and assistance to
correctly perform the exercises on a regular basis. PeriCoach is the only mobile health incontinence
treatment system that enables clinicians to remotely monitor, manage and motivate their patients. It
is effectively a personal trainer for pelvic floor exercises which provides real-time feedback during
exercises and enables progress to be monitored by both the user and her clinician. It aims to promote
adherence to exercise programs with clinicians involved in all stages of the device’s development. We
also note that PeriCoach is the only device that directly reads the contraction muscle force (rather
than air pressure or electrical activity) to provide an accurate indication of strength.
We also note the recent emergence of Elvie (see Figure 3), a mobile health device which uses a
dynamometer to measure force torque and power of the pelvic floor muscles. It is being developed by
UK-based Chiaro which has the co-founders of Google Maps and Jawbone as early investors. Chiaro
aims to launch Elvie in March 2015 for £95 (c$175) and is currently taking preorders at £55 (c$100).
However, it is worth noting that the Elvie device does not communicate with clinicians and Chiaro has
not provided any updates on its regulatory progress.
24 November 2014 Analytica Limited
RESEARCH NOTE – PATERSONS SECURITIES LIMITED 5
All information and advice is confidential and for the private information of the person to whom it is provided and is provided without any responsibility
or liability on any account whatsoever on the part of this firm or any member or employee thereof.
Potential Catalysts
Commencing Global Launch
ALT commenced a controlled market release of its Android-compatible device and App in June 2014 to
a select group of healthcare professionals. The controlled release was designed to assist with process
optimisation and ALT indicated that a number of production efficiency, ordering and logistics
improvements had been identified. The first units were shipped to trained PeriCoach accredited pelvic
floor exercise clinics and specialists. This allowed patients to purchase a PeriCoach device and
subscription during a consultation with an accredited health professional using dedicated point-of-sale
hardware supplied by ALT. Controlled market release sales through the pericoach.com website also
initially required a referral code from an accredited pelvic floor specialist clinician.
ALT commenced the public launch of PeriCoach in Australia and New Zealand during November 2014.
The Company now plans to establish new sales channels including direct-to-customer sales and
arrangements with distribution partners and has recruited a sales team for the NSW, Queensland,
Victoria / Tasmania and WA / SA regions. ALT is planning to follow the consumer product launch in
Australia and New Zealand with launches in the US and Europe during 2015 after it has received the
necessary marketing approvals.
We also note that the production of PeriCoach is highly scalable with volumes able to be increased
without significant expense. The assembly and testing process is also not labour-intensive which
enables onshore production to be cost-effective after quality control and other overhead costs are
also taken into account. ALT indicated that it has a current production capacity of 2,400 units per
week with existing tooling designed for greater than 18 months at the maximum capacity. It also
indicated that the capacity can be doubled for c$50k under the existing design (c3 months to
implement) and massively increased for c$500k under a redesign (c6 months to implement).
Encouraging Demand Indications
ALT is adopting a top-down approach with its marketing strategy to drive endorsement from Key
Opinion Leaders, specialists and GPs. In anticipates that the involvement of clinicians during the
development phases will ensure the device’s relevance and path to market. In addition, the direct-to-
consumer model aims to better patient outcomes without imposing a cost on clinicians. The Company
indicated that recruiting clinicians is a key marketing focus and it had received strong support and
enthusiasm.
In February 2014, PeriCoach received encouraging feedback from a commissioned market research
phone survey with key findings illustrated in Figure 4. Notably, the survey found that up to 50% of
the women interviewed indicating that they would use the device if recommended by their clinician.
In March 2014, ALT exhibited PeriCoach at the Urological Society annual scientific meeting and
indicated that it was ‘overwhelmed’ by the positive reaction from clinicians. In April 2014, ALT
provided an update of PeriCoach marketing activity indicating that more than 75% of the c250 pelvic
healthcare professionals visiting its booth at recent incontinence conferences have asked to be kept
informed of product updates, release date and professional training programmes.
Figure 4: Market research phone survey (February 2014)
Source: Analytica
In September 2014, ALT also provided an update from the national Continence Foundation of
Australia meeting that was recently held. The state and national Continence Foundation of Australia
meetings have been a key focus in driving clinician awareness and recruiting. ALT indicated that the
PeriCoach team recruited over 75 clinicians and trained 23 during the national meeting, with the
marketing booth well attended and received by delegates.
24 November 2014 Analytica Limited
RESEARCH NOTE – PATERSONS SECURITIES LIMITED 6
All information and advice is confidential and for the private information of the person to whom it is provided and is provided without any responsibility
or liability on any account whatsoever on the part of this firm or any member or employee thereof.
Global Mobile Health Trend
Mobile Health (mHealth) allows for mass customisation of healthcare including individualised
monitoring, treatment plans and measurement of treatment response. It also helps make the patient
an active driver of their own care which helps to facilitates behavioural modification. Through the use
of proprietary sensors, software and algorithms, smartphones can effectively be turned into medical
devices to deliver specific diagnostic, monitoring or treatment benefits. The emerging mHealth
technology field will ultimately allow clinicians to securely access patient monitoring data, review
treatment progress and medication adherence and adjust patient action plans accordingly.
According to Deloitte’s 2012 TMT report, over 1bn smartphones are expected to be sold annually by
2015, providing unprecedented mobile access to information. mHealth has been a key beneficiary of
this trend with 247m people downloading mHealth apps in 2012, up from 124m in 2011 according to
Research2Guidance. According to a 2011 Pew Research Center report, global mHealth revenue is
projected to reach $23bn by 2017 with monitoring services for chronic diseases accounting for c65%
of $15bn. This is illustrated in Figure 5. In addition, Kalorama Info predicted in a 2012 report that the
US wireless monitoring market for chronic diseases will triple over the next 3 years to $22bn as
shown in Figure 6.
Figure 5: 2017 mHealth services revenue Figure 6: US wireless monitoring devices
Source: Pew Research Source: Kalorama Info
Key Risks
General Medical Device Operating Risks
• Obtaining, securing and maintaining rights to technology and patents are an integral part of
securing potential product value in the outcomes of medical device R&D and can lead to
patent disputes
• Complex government health regulations, which are subject to change, add uncertainty to
obtaining approval to market medical devices and this risk increasingly also applies to mobile
health applications that conform to certain device regulatory guidelines
• The actions of current competitors and new entrants is a risk that exists in the medical device
industry, and may include direct competitors with a comparable device or indirect
competitors such as incontinence pad manufacturers
• Market acceptance of medical devices is uncertain and can be impacted by difficulties in
marketing, acceptance by patients and clinicians, delays in marketing and the advancement
of new competitive products
• Development and sales objectives depend on the principal members of the development,
marketing and management teams and could be impacted by the loss of key personnel
• Potential product liability risks and warranty claims are inherent in the manufacturing,
marketing and use of medical devices (PeriCoach is expected to have a 2-year warranty)
• Any disruption in sourcing key raw materials or difficulties faced by its suppliers could
adversely impact operational performance
• Medical device development and commercialisation requires funding over a long period of
time, however, we note that ALT is now fully funded to launch PeriCoach and can increase
the production capacity without a significant expense if required
24 November 2014 Analytica Limited
RESEARCH NOTE – PATERSONS SECURITIES LIMITED 7
All information and advice is confidential and for the private information of the person to whom it is provided and is provided without any responsibility
or liability on any account whatsoever on the part of this firm or any member or employee thereof.
Company Structure
Capital Structure
Figure 7: Capital structure
Description Number (m)
Ordinary Fully Paid 815.4
Placements raising $1.2m at 3.0cps in October / November 2014 38.3
1 for 8 Rights Issue raising $2.6m at 3.0cps in October 2014 85.5
Total Ordinary Fully Paid 939.2
Options - exercise price 3.3cps; expiry 29 October 2018 44.5
Options - exercise price 4.4cps; expiry 12 February 2019 5.0
Options - exercise price 7.4cps; expiry 22 May 2019 6.4
Source: IRESS and Patersons Securities
ALT indicated that the $3.8m in capital raised during October and November 2014 would be used to
fund marketing costs in connection with the launch of PeriCoach, as well as general working capital
expenses. CEO Geoff Daly commented that the capital raising enables ALT to accelerate sales and
marketing opportunities and shareholders should expect to see and hear more about the product in
mainstream media over the coming months.
Key Shareholders
Figure 8: Key shareholders
Shareholder Number (m) Holding (%)
Dr Michael Monsour (Chairman) 127.7 13.7%
Source: Analytica
Prior to the capital raisings which took place in October 2014, Directors and Associates held 18.4% of
shares on issue and an estimated 70.0% of options.
24 November 2014 Analytica Limited
RESEARCH NOTE – PATERSONS SECURITIES LIMITED 8
All information and advice is confidential and for the private information of the person to whom it is provided and is provided without any responsibility
or liability on any account whatsoever on the part of this firm or any member or employee thereof.
Board of Directors
Dr Michael Monsour – Executive Chairman
Dr Monsour is a medical practitioner with business interests in Queensland medical centres. He
operates a medical management company that provides management support to medical
practitioners and is also one of Australia's leading providers of software systems for Occupational
Health and Safety and Medical Accounting.
Warren Brooks – Non-Executive Director
Mr Brooks was the Managing Director and Founder of boutique Financial Advisory firm Clime AFM
which was a wholly owned subsidiary of ASX-listed Clime Investment Management. He founded
Australian Financial Management (Investment) in 1998 and sold the business to Clime Investment
Management Limited in 2006. Mr Brooks previously had 28 years’ experience working in Investment
Banking and Stockbroking.
Ross Mangelsdorf – Non-Executive Director
Mr Mangelsdorf is a Chartered Accountant with 27 years’ experience. He works with SME production,
manufacturing and retail firms assisting them with business, taxation and management services,
taking on the role of Chief Financial Officer for a number of firms. Mr Mangelsdorf is a director of a
Queensland-based land development company and a chartered accounting firm.
Carl Stubbings – Non-Executive Director
Mr Stubbings’ experience in the sector spans over 30 years with a focus on medical diagnostics as
well as biotechnology. He has specialised in sales with a particular emphasis on marketing across
North America, Latin America, Asia Pacific and Europe as well as roles covering manufacturing and
administration.
Management
Geoff Daly – Chief Executive Officer
Mr Daly is a Chartered Biomedical and Mechanical Engineer with 22 years of professional engineering
experience, the last 17 in the medical device industry. He has an honours degree in Mechanical
Engineering from the University of Queensland and an Executive MBA from the Australian Graduate
School of Management in Sydney. Mr Daly has expertise in design processes, quality systems, and
business system improvement, and is trained in the use of Six Sigma tools. He has extensive hands-
on design experience of product development in FDA QSR and ISO 13485 environments in some of
Australia's largest and smallest medical device companies.
Bryan Dulhunty – Company Secretary
Mr Dulhunty is the founder of CoSA Life Sciences, a specialist Life Science company established for 15
years providing Company Secretarial, CFO, general management and strategic advice to life science
companies. He has extensive experience in the financial control of Life Science companies previously
holding positions of Executive Chairman, Managing Director and CFO roles of various listed life
sciences companies.
24 November 2014 Analytica Limited
RESEARCH NOTE – PATERSONS SECURITIES LIMITED 9
All information and advice is confidential and for the private information of the person to whom it is provided and is provided without any responsibility
or liability on any account whatsoever on the part of this firm or any member or employee thereof.