AVITA Medical Limited (Company) (ASX:AVH) (NASDAQ:RCEL)
is pleased to announce that the Australian Securities and
Investments Commission (ASIC) has registered the scheme
booklet (Scheme Booklet) in relation to the proposed scheme
of arrangement under which AVITA Therapeutics, Inc. (Avita
US), a newly-formed company incorporated in Delaware in the
United States of America, will become the parent company of the
Company and its subsidiaries (Avita Group) for the purposes
of effecting a redomiciliation of the Avita Group from Australia to
the United States of America (Scheme).
A copy of the Scheme Booklet in full is available on the
Company’s website (https://www.avitamedical.com/news-events). The
Scheme Booklet includes the Notice of Scheme Meeting and an
Independent Expert’s Report prepared by BDO Corporate Finance
Limited, who has concluded that, in its opinion, the Scheme is in
the best interests of the Company’s shareholders as a whole.
Despatch of Scheme Booklet
A copy of the Scheme Booklet, which includes the Notice of
Scheme Meeting and Independent Expert’s Report, and a proxy form,
will be sent to the Company’s shareholders by post or
electronically (for those shareholders who have opted to receive
notices electronically) on or before 14 May 2020.
Scheme meeting
The Scheme meeting will be held exclusively as a virtual meeting
by way of a live webcast at 9.00am (AEST) on 15 June 2020. The
Company’s shareholders are encouraged to read the Scheme Booklet in
its entirety and vote at the Scheme meeting either by participating
in the live webcast or by appointing a proxy, attorney or corporate
representative (as applicable). Details and instructions on how to
take part and vote are included in the Scheme Booklet.
Financial reporting relief granted by ASIC
In connection with the Scheme, the Company applied to ASIC for
relief from the requirement for the Company to prepare and lodge
with ASIC an annual report in accordance with Australian
International Financial Reporting Standards (AIFRS) for the
financial year in which the Scheme was implemented.
The reason for the Company seeking this relief was to reduce the
substantial costs, burden and risks associated with the dual
financial reporting and related compliance obligations that the
Company currently has in both the United States and Australia as a
result of being treated (since 31 December 2019) as a domestic
public company in both of these jurisdictions for financial
reporting purposes.
The Company is pleased to announce that ASIC has granted relief
so that, if the Scheme is implemented on or before 30 June 2020,
the Company will not be required to prepare and lodge with ASIC an
annual report for the financial year ending 30 June 2020 in
accordance with AIFRS.
In order to comply with the conditions to the relief:
- the Company and its Australian subsidiaries will enter into a
new deed of cross guarantee with Avita US as the new parent entity
of the Avita Group on and from the Implementation Date of the
Scheme (29 June 2020); and
- Avita US will prepare and file with the U.S. Securities and
Exchange Commission for the financial year ending 30 June 2020 in
respect of the Avita Group an Annual Report on Form 10-K in
accordance with U.S. Generally Accepted Accounting Principles
(which will be audited) by 31 August 2020.
If the Scheme is implemented on or before 30 June 2020, it is
anticipated that the Avita Group will save approximately A$400,000
in external professional costs for the reporting period ending 30
June 2020 as a result of obtaining this relief.
Authorised for release by the Chief Financial Officer of AVITA
Medical Limited.
ABOUT AVITA MEDICAL LIMITED
AVITA Medical is a regenerative medicine company with a
technology platform positioned to address unmet medical needs in
burns, chronic wounds, and aesthetics indications. AVITA Medical’s
patented and proprietary collection and application technology
provides innovative treatment solutions derived from the
regenerative properties of a patient’s own skin. The medical
devices work by preparing a RES® REGENERATIVE EPIDERMAL
SUSPENSION), an autologous suspension comprised of the patient’s
skin cells necessary to regenerate natural healthy epidermis. This
autologous suspension is then sprayed onto the areas of the patient
requiring treatment.
AVITA Medical’s first U.S. product, the RECELL® System, was
approved by the U.S. Food and Drug Administration (FDA) in
September 2018. The RECELL System is indicated for use in the
treatment of acute thermal burns in patients 18 years and older.
The RECELL System is used to prepare Spray-On Skin™ Cells using a
small amount of a patient’s own skin, providing a new way to treat
severe burns, while significantly reducing the amount of donor skin
required. The RECELL System is designed to be used at the point of
care alone or in combination with autografts depending on the depth
of the burn injury. Compelling data from randomized, controlled
clinical trials conducted at major U.S. burn centers and real-world
use in more than 8,000 patients globally, reinforce that the RECELL
System is a significant advancement over the current standard of
care for burn patients and offers benefits in clinical outcomes and
cost savings. Healthcare professionals should read the INSTRUCTIONS
FOR USE - RECELL® Autologous Cell Harvesting Device
(https://recellsystem.com/) for a full description of indications
for use and important safety information including
contraindications, warnings and precautions.
In international markets, our products are marketed under the
RECELL System brand to promote skin healing in a wide range of
applications including burns, chronic wounds and aesthetics. The
RECELL System is TGA-registered in Australia and received CE-mark
approval in Europe.
To learn more, visit www.avitamedical.com.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This letter includes forward-looking statements. These
forward-looking statements generally can be identified by the use
of words such as “anticipate,” “expect,” “intend,” “could,” “may,”
“will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,”
“target,” “project,” “continue,” “outlook,” “guidance,” “future,”
other words of similar meaning and the use of future dates.
Forward-looking statements in this letter include, but are not
limited to, statements concerning, among other things, our ongoing
clinical trials and product development activities, regulatory
approval of our products, the potential for future growth in our
business, and our ability to achieve our key strategic, operational
and financial goal. Forward-looking statements by their nature
address matters that are, to different degrees, uncertain. Each
forward- looking statement contained in this letter is subject to
risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statement.
Applicable risks and uncertainties include, among others, the
timing of regulatory approvals of our products; physician
acceptance, endorsement, and use of our products; failure to
achieve the anticipated benefits from approval of our products; the
effect of regulatory actions; product liability claims; risks
associated with international operations and expansion; and other
business effects, including the effects of industry, economic or
political conditions outside of the company’s control. Investors
should not place considerable reliance on the forward-looking
statements contained in this letter. Investors are encouraged to
read our publicly available filings for a discussion of these and
other risks and uncertainties. The forward-looking statements in
this letter speak only as of the date of this release, and we
undertake no obligation to update or revise any of these
statements.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200511005923/en/
U.S. Media Sam Brown, Inc. Christy Curran Phone +1
615 414 8668 christycurran@sambrown.com
O.U.S Media Monsoon Communications Rudi Michelson
Phone +61 (0)3 9620 3333 Mobile +61 (0)411 402 737
rudim@monsoon.com.au
Investors: Westwicke Partners Caroline Corner
Phone +1 415 202 5678 caroline.corner@westwicke.com
AVITA Medical Ltd David McIntyre Chief Financial Officer
Phone +1 661 367 9178 dmcintyre@avitamedical.com
AVITA Medical (ASX:AVH)
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