Investor Presentaiton
Risks¹
Topic
Summary
Topic
Summary
Reliance on partners
Product acceptance
Competition
Product pipeline and
development of new products
Intellectual property
Product liability
Manufacturing/production
risks
A large portion of AROA's revenue is reliant on its US sales and distribution partner, TELA Bio.
TELA Bio is a US corporation listed on NASDAQ, whose business focuses on the sale, distribution
and marketing of the OviTex product range. A slowdown, decrease in demand or failure to grow
demand from TELA Bio could adversely impact AROA's operating and financial performance.
AROA's growth and the commercial success of AROA's products and future products is reliant on
the acceptance of AROA's products by healthcare professionals, including surgeons and wound
care specialists. The acceptance of AROA's existing products may slow, and planned future
products may gain acceptance slower than planned or may not gain broad market acceptance by
healthcare professionals which, should this arise, would impact AROA's operating and financial
performance
AROA competes against many existing and potential competitors with significantly more resources
than AROA and with greater access to more markets. AROA's competitors may be able to increase
market share through aggressive marketing campaigns, product improvements, acquisitions or
price discounting which will affect AROA's market share and margins.
AROA's commercial success is dependent on the continued improvement of existing products and the
research and development of new products utilising the AROA ECM technology platform. Product
development involves a high degree of risk, and there are no guarantees that new product
development efforts will result in any clinically or commercially successful products.
The value of AROA's products depends in part on its success in obtaining and maintaining issued
patents, trademarks and other intellectual property rights and protecting the Company's
proprietary technology. If AROA's intellectual property and proprietary technology is not
adequately protected, competitors may be able to use the technologies or the goodwill AROA has
acquired in the marketplace and erode or negate any competitive advantage AROA may have,
which could harm AROA financially.
Any defects in AROA's products may harm AROA and its customers' reputation and business. AROA
may also be subject to warranty and liability claims for damages related to defects in its
products.
AROA manufactures its products in a single location in Auckland, New Zealand and is exposed to risks of
harm caused by natural or man-made disasters, or operation or human error, which may result in
manufacturing disruptions or an inability to manufacture and produce its products for some time. AROA has
formal commercial agreements in place for most of its critical suppliers eg Ovine rumen supplier. A limited
number of supply arrangements are subject to course of conduct, rather than set out in written agreements.
Whilst AROA considers this to be reasonably normal in the clinical/biosurgery industry. To the extent
practicable, AROA has in place or has identified alternate suppliers. If alternative supply arrangements are
not in place, this could result in manufacturing disruptions.
Supply of Ovine rumen
Hazardous substances
Country/region specific risks
Macro-economic risk
Market conditions
Reliance on key personnel
Other risks
The ovine (sheep) rumen used in the manufacturing of AROA products is currently sourced from
New Zealand sheep. Currently, New Zealand sheep are not known to carry any prion disease
(progressive neurodegenerative disorders, including scrapie disease). However, the geographic
concentration of AROA's ovine rumen supply creates risks of disruption due to natural disasters,
disease or other events.
AROA's activities in manufacturing its products involve the controlled storage, use and disposal of
hazardous materials. AROA is subject to laws and regulations governing the use, generation,
manufacture, storage, handling and disposal of these hazardous materials. Although AROA's
safety procedures for handling and disposing of these materials and waste products comply with
these standards, AROA cannot eliminate the risk of accidental injury or contamination from the use,
storage, handling or disposal of hazardous materials.
AROA has operations in the US and has to comply with a range of different US legal and regulatory
regimes. As AROA expands the sales of its products geographically into new international
jurisdictions, it is subject to the risks associated with conducting its business in the relevant
countries, which include adapting to, and complying with, the differing laws and regulations,
business and clinical practices, and patient preferences in foreign countries, developing and
managing foreign relationships and operations and being subject to the political and economic
climate of the various countries.
The ongoing impact of the Coronavirus pandemic (COVID-19) on the Company's operations is not
currently fully ascertainable and may not be known for a period of time. Following COVID-19, the
Company has experienced a reduction in sales of its products due to elective surgeries being
cancelled and outpatient clinics being closed as a result of COVID-19. Whilst AROA has seen a
continued positive trend in US medical procedure numbers to date, these are yet to return to pre
COVID-19 levels.
In light of the COVID-19 pandemic, extra care should be taken when assessing the risks
associated with investment. The rapidly changing COVID-19 situation is bringing
unprecedented challenges to global financial markets, and the economy as a whole.
There is no assurance that AROA will be able to retain key personnel. The departure of key
personnel may adversely affect AROA until suitable replacements are recruited.
The above risks are a summary of some of the key risks, but not an exhaustive list of all of the risks
associated with the Company or an investment in the Shares. Further details on the risks
summarised in this Section and other key risks are included in Section 5 of the IPO Prospectus
dated 22 June 2020, and investors should review all of those risks carefully before making an
investment decision.
Notes
1. This section is not intended to be a fulsome overview of key risks. For detailed information on the specific risks and general risks relating to an investment in AROA, please see section 5 of the IPO Prospectus dated 22 June 2020
AROAT™
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