U.S. RECELL® System product sales of A$5.81M
for fiscal third quarter
AVITA Medical Limited (ASX: AVH, NASDAQ: RCEL), a regenerative
medicine company with a technology platform positioned to address
unmet medical needs in therapeutic skin restoration, reported
financial results for the fiscal third quarter ended 31 March 2020
(Q3) today in its Appendix 4C - Quarterly Cash Flow Report filed
with the Australian Securities Exchange (ASX).
U.S. Commercial Sales of RECELL® System for Quarter Ended 31
March 2020
Product sales and other revenues for the third quarter and nine
months ended 31 March 2020 were as follows (unaudited):
Three Months Ended
Nine Months Ended
(Thousand Australian $’s)
31
March
31
March
2020
2019
2020
2019
U.S. product sales
A$5,809
A$2,206
A$15,083
A$3,308
International product sales
148
189
558
900
Total product sales
5,957
2,395
15,641
4,208
Other income (including BARDA)
2,108
2,427
5,954
7,540
Total revenue
A$8,065
A$4,822
A$21,595
A$11,748
“Our strong fiscal third quarter results demonstrate continued
growing adoption trends within both our existing and new RECELL
System customers,” said Dr. Mike Perry, AVITA Medical’s Chief
Executive Officer. “In the current COVID-19 environment, we are
deploying various strategies, including supply redundancies and
digital training, to drive usage and continue serving burn surgeons
and their patients. While severe burn treatments are not elective
procedures, there has been a pause in enrollment in some of our
clinical trials due to COVID-19; however, we are advancing our
pipeline and are currently developing the protocol and FDA
Investigational Device Application for the RECELL vitiligo pivotal
study. In addition, we are continuing to make progress toward
redomiciling the Company to the United States to better align the
Company’s corporate structure with our U.S. business
operations.”
Corporate Update
Our commercial efforts in Q3 progressed well with quarterly
growth exceeding 20% across both procedural volume and U.S. RECELL
System revenue. Q3 represents our strongest quarter since launching
in the United States in January last year reflecting strong
customer uptake, even with the COVID-19 pandemic beginning toward
the end of the quarter. In the quarter ended 31 March 2020, we also
added nine new customers and certified an additional 21 surgeons,
bringing our total to 69 customers and 205 certified burn surgeons,
together with progressing our ongoing clinical investigations with
first patient enrollment in our soft tissue and pediatric partial
thickness studies. All of these factors collectively demonstrate
ongoing high interest in the RECELL System, together with
consistent usage and acceptance across our growing customer
base.
We have seen consistent growth since the launch of the RECELL
System and we have, so far, been somewhat insulated from the
COVID-19 challenges to-date given the treatment of burns patients
is generally not elective nor deferrable. While we didn’t see any
impact to the rate of burn incidence or RECELL System utilization
during the quarter, it continues to be difficult to predict the
breadth of potential impacts over the coming months due to the
current COVID-19 macroenvironment. These considerations operate in
addition to the overarching burn environment which is inherently
“lumpy” and difficult to forecast.
Set out below is additional information which builds on our two
earlier news releases on our progress and COVID-19
implications:
- Our field force, as with all our employees, continue to operate
largely on a work-from-home basis with severely limited travel.
These measures have been implemented in accordance with relevant
government requirements and, more importantly, to protect the
safety and welfare of our employees. We continue to monitor the
environment but, at this juncture, do not expect a relaxation or
reduction of the restrictions until June at the earliest, and
potentially longer.
- The Company is well-positioned from a supply and distribution
perspective and does not envisage any disruption or delays to the
availability of the RECELL System. In addition, the Company has
established two offsite storage points which house RECELL System
inventory in case of disruption at the Company’s manufacturing
facility in Ventura, California.
- With nationwide COVID-19 restrictions, our field force has very
limited face-to-face access with our existing and potential new
customers and our current commercialization efforts continue to be
largely driven in a remote format. These activities may be
summarized as follows:
- Extensive digital and telephonic outreach in a variety of
forms.
- Webinars, teach-ins, digital proctoring, remote “in-service”
interactions, remote wet labs are some examples.
- Live digital and audio case support continues as required.
- Live case support by our field force in a very limited number
of hospitals.
- Identification of certain unique cases that demonstrate the
clear benefits of the RECELL System, such as the “faces”
presentation which may be accessed at
https://www.avitamedical.com/about-recell-us.
- We also continue to conduct remote teach-ins and regional
Advisory Board forums, to enable shared RECELL System experience
and to broaden physician awareness around the unique benefits of
the RECELL System (including one this past weekend).
- We reached further corporate milestones during the quarter by
initiating two (2) pivotal studies with treatment of the first
patient in our soft tissue reconstruction study, and in our
pediatric partial-thickness (scald) study.
- We were disappointed with the understandable cancellation of
the 52nd annual American Burn Association (ABA) Meeting in March;
however, data abstracts from the meeting are summarized at
https://www.avitamedical.com/uploads/pdf/ABA-Data-Press-Release-04022020.pdf.
3Q Review & 2020
Perspective
As we look back at Q3, this quarter represents one of our best
performances since launch and included revenue and procedural
volume growth exceeding 20%. Q3 also marked the first quarter for
the RECELL System to be utilized in more than 400 procedures
marking continued strong endorsement of the unique benefits that
the RECELL System offers.
A summary of our quarterly commercial highlights is set out
below:
(United States $'s)
Quarter Ended 31-Mar-19
30-Jun-19 30-Sep-19 31-Dec-19 31-Mar-20
US RECELL Sales
$
1,577,341
$
2,036,270
$
3,183,030
$
3,178,160
$
3,861,530
Cumulative. U.S. RECELL Sales
$
1,577,341
$
3,613,611
$
6,796,641
$
9,974,801
$
13,836,331
New Accounts
9
21
13
8
9
Cumulative Accounts
18
39
52
60
69
Physicians Trained
32
39
21
27
21
Cumulative Physicians
97
136
157
184
205
As we look back at a very successful quarter and think about the
path ahead, it is clear that our customers are now operating under
challenging conditions, and this is creating a broad spectrum of
commercial behavior which varies greatly and is driven by
heterogeneic considerations such as:
- Localized COVID-19 conditions (i.e. whether the hospital is
located within or near to a COVID-19 “hotspot”).
- The breadth of the infrastructure within a relevant hospital,
and its inherent ability to cope with COVID-19 patient admission
surges with, or without, impacting the treatment of burn patients
in that hospital.
- The availability of proximate hospital facilities with burn
treatment capabilities that enable burn patients to be
re-distributed to preserve COVID-19 response capabilities.
- Institutional specific policies that limit the number of ICU
beds available to treat burn patients.
Given the above, we are experiencing a wide degree of commercial
variability across the United States, which is representative of
the inconsistent and regionalized nature of COVID-19 outbreaks. In
regions where we see highly restrictive operating conditions or
constrained burn treatment resources, our ability to be effective
in those locations is impacted by the number of our customers in
those regions and, more importantly, the associated degree of
RECELL System experience (i.e. our outcomes are impacted by
regional COVID-19 considerations and whether the affected hospital
is, for example, a “super user”).
Independent of the above and despite burn procedures being non
elective, our experience tends to indicate that the incidence of
burns will not be immune from the lower levels of economic activity
(e.g. manufacturing, retail, etc.) and reduced travel and road
activity that are presently occurring in the United States due to
the COVID-19 pandemic. Similar to the experience with the declining
number of car accidents and heart attacks, our best guess is that
the number of burns patients could decline during the COVID-19
overhang and that decline could potentially occur in the range of 0
to 20%.
Despite these unprecedented operating conditions, our commercial
team continues to be highly active with our customers as
circumstances permit. However, the lack of face-to-face time with
our customers and the fact that hospital resourcing is generally
focused around COVID-19 means that new account accrual and the
opportunity for our field force to assist newer accounts to develop
broader burns treatment experience (i.e. migrating from bigger to
smaller burns, and using the RECELL System without autografting) is
presently impaired.
Other Developments and
Updates
As broadly reported across the United States, the COVID-19
pandemic has required hospitals and clinical research institutions
to prioritize their resources, efforts and facilities to expand,
and reserve, capacity for the treatment of COVID-19 patients. The
direct implication of this is that clinical investigational studies
are not generally being actively pursued and, in consequence,
enrollment in our existing clinical studies (i.e. our soft tissue
reconstruction pivotal, pediatric partial-thickness pivotal study
and our vitiligo feasibility study) is largely paused pending
further developments with COVID-19. We are hopeful that the present
re-prioritization of resources away from clinical studies will
lessen in the short term to allow a restart of our studies. We will
provide updates here as appropriate.
Vitiligo
Over the last few months, we have been exploring the possibility
of advancing a pivotal study that would evaluate the safety and
effectiveness of the RECELL System in the treatment of stable
vitiligo patients. These efforts have incorporated a range of
discussions with industry experts and key opinion leaders for the
purpose of determining essential elements of a potential clinical
protocol including, among other things, primary endpoints, study
population, and the treatment protocol.
The above efforts are now approaching completion and we are
presently in the process of compiling an Investigational Device
Exemption (“IDE”) application for the vitiligo pivotal study which
we plan to submit to the U.S. Food & Drug Administration
(“FDA”) before the end of June. The current proposal remains
formative but is expected to incorporate the following
elements:
- Eligible patients with stable vitiligo as confirmed by no new
lesions in the last twelve (12) months.
- The treatment arms would include skin cell suspensions with
multiple dilutions.
- Patients will act as their own control by providing two (2)
areas of depigmentation.
- Primary endpoint at twenty-four (24) weeks will likely speak to
the extent of re-pigmentation as determined by a blinded evaluator,
with a patient rated satisfaction score as a secondary
endpoint.
The Company believes the vitiligo market represents a large,
attractive market, and one for which there is no approved therapy
for patients. Vitiligo is an autoimmune deficiency which creates
enormous quality of life implications for patients and is
comparable to the stigma experienced by patients suffering from
psoriasis, acne or rosacea. Subject to receiving FDA approval for
the IDE, the Company is hopeful of being ready to initiate this
pivotal study in the second half of 2020 (subject to COVID-19
developments). If the pivotal study thereafter successfully meets
its endpoints, the Company will leverage its existing premarket
approval (“PMA”) to submit a PMA supplement to the FDA (as opposed to being
required to submit a full PMA) thereby seeking to add a new
indication for use (i.e. patients with stable vitiligo) to our
existing acute thermal burns indication.
Independent of the above efforts, the Company already has an IDE
for a vitiligo pilot study and recently entered into a research
collaboration with the University of Massachusetts. As previously
disclosed, this pilot study (n=10) will also include patients who
have vitiligo lesions that have been stable for at least one year.
This study will provide incremental learnings and data, operating
in parallel with the Company’s new efforts to bring forward a
pivotal study with the FDA as discussed above.
Pediatric Studies
In early March 2020, we announced the initiation of a pivotal
trial for the treatment of pediatric scald injuries with enrollment
of the first patient at the Arizona Burn Center at Valleywise
Medical Health Center in Phoenix, AZ. This study seeks to
demonstrate that treatment with the RECELL System of
partial-thickness burn injuries within 72-hours can safely and
effectively increase the incidence of healing at day 10 when
compared to a standard wound dressing. This study is ongoing, but
enrollment is paused given the COVID-19 pandemic.
Additionally, the Company has a second pediatric study which is
commonly referred to as the “pediatric donor study”. This is a
randomized clinical study to compare the healing of a donor site in
pediatric patients treated with the RECELL System versus
conventional care (i.e. standard dressings only). This study was
conceived more than three (3) years ago and prior to the PMA, and
the growing commercial adoption, of the RECELL System in the United
States. Given the premarket approval of the RECELL System and the
resultant strong early adoption, the Company believes that there is
little clinical utility, and little practical benefit, in
continuing this study (including no ability for this study to
expand our existing approved burn indication). For these reasons,
the Company is actively pursuing terminating this study (but
continuing with the pediatric partial thickness study mentioned
above).
Data Publication
A study titled “A pilot multi-centre prospective randomized
controlled trial of RECELL for the treatment of venous leg ulcers,”
by Paul D. Hayes, Keith G. Harding, Susan M. Johnson, Charles
McCollum, Luc Teot, Kevin Mercer, and David Russell published
online in the International Wound Journal in February and will also
publish in the June print edition of the journal.1
Intention to Redomicile to the United
States of America
On 20 April 2020, we announced our intention to redomicile from
Australia to the United States. Under the proposed redomiciliation,
AVITA Therapeutics, Inc.2 (“AVITA US”) will become our new parent
company. While the group will have a new parent company as a result
of the redomiciliation, underlying operations, business and assets
of the group will remain completely unchanged.
Since 2018, the Company has had no physical business presence,
and only one (1) employee, in Australia. In addition, our immediate
commercial focus is on unlocking the U.S. market, where we
currently source virtually all of our revenue. Against this
background, the beneficial owners of a majority of our shares are
now located outside Australia, with ~50% of shares being
beneficially owned by investors in the United States alone.
The redomiciliation proposal therefore provides the Company with
the opportunity to align our corporate structure with our business
and beneficial ownership, and has the added benefit of providing a
familiar investment offering (versus our existing American
Depositary Shares) to investors in the United States, which is the
world’s largest capital market in terms of market capitalization
and trading volume. Importantly, the proposal allows us to
substantially reduce our financial reporting and compliance burden
and save costs, while not impacting the quantity of financial
information provided to investors or disrupting trading on either
the ASX or NASDAQ.
The proposal, which will be implemented pursuant to a scheme of
arrangement under Australian law, is subject to approval by
shareholders (at a shareholders’ meeting currently tentatively
scheduled for 15 June 2020) and orders of the Federal Court of
Australia as well as regulatory review by various government
bodies, including the Australian Securities and Investments
Commission and the Foreign Investment Review Board. The Company is
anticipating that it will be in a position to send to shareholders
in mid-May 2020 a Scheme Booklet that will contain a detailed
explanation of the redomiciliation proposal, including the
advantages, disadvantages and risks of the proposal, together with
an Independent Expert’s report that will set out whether, in the
expert’s opinion, the proposal is in the best interests of
shareholders as a whole.
We have received a number of enquiries since the proposal was
announced on 20 April 2020 and, as such, for ease of reference we
set out below some key features of the redomiciliation proposal.
It is however important that shareholders
appreciate that the below is a brief and high level overview of
some key aspects of the proposal (if implemented), and the Board of
Directors strongly encourages shareholders to review the Scheme
Booklet in detail when they receive it and to take part in the
shareholders’ meeting. Further, shareholders should consult their
financial, legal, taxation or other independent and qualified
professional adviser if they have any questions in relation to the
proposal.
- Appendix A provides a simple illustrative example of how the
redomiciliation will affect eligible shareholdings.
- Electronic trading will continue on both the ASX and
NASDAQ; that is, shareholders will continue to be able to trade
on the ASX and NASDAQ in a similar fashion to how they have always
traded (except that trading will now be in securities of AVITA
Therapeutics, Inc. rather than AVITA Medical Limited).
- Trading is expected to continue to use the same ticker codes;
the ASX will continue to use “AVH” and NASDAQ will continue to use
“RCEL”.
- Eligible shareholders3 will have the same proportionate
value and ownership on completion of the redomiciliation as
they held before the redomiciliation (subject to adjustments for
fractional interests). In other words, underlying ownership and
proportionate value for eligible shareholders will remain unchanged
by the proposal.
- Under the proposal, eligible shareholders will swap their
existing interests in the Company for:
- Common stock in AVITA US, if shareholders currently hold
American Depositary Shares (“ADSs”) in the Company (which are
presently traded on NASDAQ).
- Holders of ADSs will receive one (1) share of common stock in
AVITA US for every 5 ADSs (which represent 100 ordinary shares)
held by them.
- As noted above, it is expected that AVITA US common stock will
trade on NASDAQ under ticker code “RCEL”.
- CHESS Depositary Interests4 (“CDIs”) in AVITA US, if
shareholders currently hold ordinary shares in the Company (which
are presently traded on the ASX).
- Ordinary shareholders will receive 5 CDIs in AVITA US for every
100 ordinary shares in the Company held by them.
- Five (5) CDI’s traded on the ASX will represent one (1) share
of common stock on NASDAQ US.
- As noted above, AVITA US CDI’s will trade on the ASX under
ticker code “AVH”.
- The proposal will have the effect of consolidating the number
of securities that the group has on issue (i.e. the same effect as
a share consolidation or a reverse split as it is more commonly
known) by reducing the number of shares the group will have
outstanding from the existing level of approximately 2.1
billion.
- The Company is presently well-capitalized and is not undertaking the redomiciliation for the
purposes of enabling a new listing of the group in a new capital
market or delisting the group from the ASX.
- If the redomiciliation proposal is approved by shareholders and
all of the relevant conditions5 that the proposal is subject to are
satisfied or waived, then shareholders will not be required to do
anything further as the above process will be facilitated
automatically by the Company and its Australian and U.S. transfer
agents (Computershare).
Third Quarter Fiscal 2020 Financial Results
(Unaudited)
(All amounts are in thousands of AUD except where noted)
A copy of the Appendix 4C - Quarterly Cash Flow Report for the
third quarter of fiscal 2020, the quarter ended 31 March 2020, is
attached. Operations for the quarter were focused primarily on the
U.S. national adoption of the RECELL System for the treatment of
acute thermal burns, and the preparation and implementation of
further clinical development of the RECELL System.
During the quarter ended 31 March 2020, total cash receipts were
A$5,743, a decrease of A$1,946 or 25% compared to the prior quarter
ended 31 December 2019. Cash receipts from customers for the
quarter ended 31 March 2020 were A$5,254, an increase of A$334 or
7% compared to the prior quarter due to increased sales. Cash
received from BARDA during the current quarter totalled A$489 a
decrease of A$2,280 or 82% compared to the prior quarter. The
decrease was the result of a one-time rate adjustment that was
received during the prior quarter ended 31 December 2019. Through
31 March 2020, cumulative payments of A$31.2 million have been
received under the BARDA contract.
Overall payments for operating expenses increased in line with
expectations during the third quarter of fiscal 2020. During the
quarter ended 31 March 2020, payments related to sales and
marketing, staffing, administrative and corporate costs totalled
A$14,287, a A$3,709 or 35% increase compared to the quarter ended
31 December 2019 due to increased initiatives and staffing costs.
During the quarter ended 31 March 2020, payments related to product
manufacturing and operating costs totalled A$1,678, a A$296 or 15%
decrease compared to the quarter ended 31 December 2019. During the
quarter ended 31 March 2020, payments for research and development
costs totalled A$1,918, a A$585 or 44% increase compared to the
quarter ended 31 December 2019 driven by the increased initiatives.
As a result of the ongoing commercialization of the RECELL System
in the U.S. along with other planned initiatives set forth by the
Company, payments for operating expenses are expected to increase
during 2020. These expense payments are expected to be partially
offset by receipts from customers and receipts under the BARDA
contract.
Total net cash used in operating activities during the quarter
ended 31 March 2020 was A$11,866, a A$5,531 or 87% increase
compared to the quarter ended 31 December 2019 driven primarily by
increased legal and professional costs associated with the planned
redomiciliation, together with annual employee incentives. Cash and
cash equivalents held at 31 March 2020 was A$129,935 compared to
A$124,658 in the prior quarter, an increase of A$5,277 or 4%. The
increase was attributable to the effect of movement in exchange
rate on cash held, partially offset by operating expenses.
Authorized for release by the Chief Executive Officer of AVITA
Medical Limited.
###
Non-IFRS Financial Measures and Other Items
We use the following measures of financial performance which are
not presented in accordance with IFRS:
- "U.S. RECELL Sales", which is the amount of revenue,
denominated in United States dollars, we generate from our
commercial efforts in relation to the sale of RECELL Systems within
the United States. Management believes that this measurement is
useful for comparing period to period sales performance, and
product acceptance, of the Company’s lead product, the RECELL
System, within the United States burn market.
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.
- Hayes, PD, Harding, KG, Johnson, SM, et al. A pilot
multi‐centre prospective randomised controlled trial of RECELL for
the treatment of venous leg ulcers. Int Wound J. 2020; 17: 742–
752. https://doi.org/10.1111/iwj.13293
- AVITA Therapeutics, Inc. is a newly incorporated Delaware
company that we control (and which has been solely established for
the purposes of redomiciliation).
- Shareholders in countries outside of Australia, the United
States, Hong Kong, New Zealand, the United, Kingdom, France,
Norway, Switzerland, the United Arab Emirates and Singapore,
together with shareholders with less than 100 shares, will not be
eligible to participate and will have the common stock or CDI
entitlement to which they would otherwise have been entitled
“cashed out” on their behalf and the net cash proceeds remitted to
them.
- Foreign companies are only permitted to trade on the ASX via
CDIs. An example of another company trading CDIs on the ASX is
Resmed, Inc., which uses ticker code “RMD” (while its primary
listing is on the NYSE, also under ticker code “RMD”).
- The conditions precedent and requisite approvals will be set
out in detail in the Scheme Booklet which is currently expected to
be made available to shareholders in mid-May 2020.
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; risks
associated with commercial, supply chain or other business
interruptions or downturns associated with national, state or
international health emergencies (e.g. pandemics), 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.
Appendix A Illustrative Example
- Ordinary shares of AVITA Medical Limited trade on the ASX under
the ticker code “AVH” and on NASDAQ under the ticker code “RCEL”
(via American Depositary Shares (“ADSs”)). Currently, 1 ADS on
NASDAQ is equivalent to 20 ordinary shares on the ASX.
- Depending on factors set out in Scheme Booklet, eligible
shareholders (see footnote 3 above) will receive AVITA US common
stock or AVITA US CDIs. It is currently anticipated that AVITA US
CDI’s will trade on the ASX under the ticker code “AVH”, and AVITA
US common stock will trade on NASDAQ under the ticker code
“RCEL”.
- Proportionate value and ownership for eligible shareholders
will be unchanged following redomiciliation (subject to adjustments
for fractional interests).
How trading works
before redomiciliation …
Ordinary Shares Held
on ASX These are equivalent ...
one(1) ADS on NASDAQ is the same as twenty (20) ordinary shares on
the ASX American Depositary Shares (ADSs) Held on
NASDAQ
Ordinary Shares
100,000
(A)
<------- -------> ADSs
5,000
(A)
(Equivalent ADS on NASDAQ
(1:20))
5,000
(A) ÷ 20
(Equivalent Ordinary Shares on the ASX (20:1))
100,000
(A) x 20
Illustrative ASX Price (AVH) in A$
A$0.46
(B)
Illustrative NASDAQ Price (RCEL) in US$
U$5.80
(B)
Illustrative A$ Value
A$46,000
(A) x (B) = (C)
Illustrative US$ Value
US$28,980
(A) x (B) = (C)
Foreign
Exchange Rate (AUD / USD)
0.63
(FX)
Foreign Exchange Rate (USD / AUD)
1.59
(FX)
Equivalent US$ Value
US$28,980
(C) x (FX)
Equivalent A$ Value
A$46,000
(C) x (FX)
Percentage Ownership
0.0046897%
Percentage Ownership
0.0046897%
Total ordinary shares outstanding:
2,132,311,745 In both cases, shareholders can
"transmute" (i.e. transfer) between the ASX and NASDAQ at will, and
vice versa. How trading will
work after redomiciliation
… Ordinary
Shares Held on the ASX → AVITA US CDIs Held on the ASX
After redomiciliation ... one(1) share of common stock on NASDAQ
is the same as five (5) CDIs on the ASX ADSs Held on NASDAQ
→ AVITA US Common Stock Held on NASDAQ
Ordinary Shares Held
Before Redomiciliation
100,000
(C)
ADSs Held Before Redomiciliation
5,000
(C)
CDIs Held After Redomiciliation
5,000
(C) ÷ 20 (=D)
<------- -------> Common Stock Held After
Redomiciliation
1,000
(C) ÷ 5 (=D)
(Equivalent Common Stock on NASDAQ
(1:5))
1,000
(D) ÷ 5
(Equivalent CDIs on the ASX (5:1))
5,000
(D) x 5
Illustrative CDI ASX price (AVH)
A$9.20
(E)
Illustrative NASDAQ Price (RCEL)
U$28.98
(E)
Illustrative A$ Value
A$46,000
(D) x (E) = (F)
Illustrative US$ Value
US$28,980
(D) x (E) = (F)
Foreign
Exchange Rate (AUD / USD)
0.63
(FX)
Foreign Exchange Rate (USD / AUD)
1.59
(FX)
Equivalent US$ Value
US$28,980
(F) x (FX)
Equivalent A$ Value
A$46,000
(F) x (FX)
Percentage Ownership
0.0046897%
[Unchanged]
Percentage Ownership
0.0046897%
[Unchanged]
Total common stock
outstanding: est. 21,323,117 The above is provided as
an illustrative example of the trading relationship between the ASX
and NASDAQ. Shareholders should not rely on this
illustration and should consult professional advisers.
Actual performance, including trading prices and patterns on the
ASX or NASDAQ, may not occur as portrayed above.
Appendix
4C
Quarterly cash
flow report for entities subject to Listing Rule 4.7B
Name of entity
Avita Medical Limited
ABN
Quarter ended (“current
quarter”)
28 058 466 523
31 March 2020
Consolidated statement of cash
flows
Current quarter $A’000
Year to date (9 months)
$A’000
1.
Cash flows from operating
activities
5,254
489
14,253
4,416
1.1
1.1a
Receipts from customers
Receipts from government contract
(BARDA)
1.2
Payments for
(1,918
)
(4,551
)
(a) research and development
(b) product manufacturing and operating
costs
(1,678
)
(4,996
)
(c) advertising and marketing
(3,740
)
(7,973
)
(d) leased assets
(267
)
(798
)
(e) staff costs
(8,062
)
(19,661
)
(f) administration and corporate costs
(2,485
)
(6,766
)
1.3
Dividends received (see note 3)
-
-
1.4
Interest received
541
838
1.5
Interest and other costs of finance
paid
-
-
1.6
Income taxes paid
-
-
1.7
Government grants and tax incentives
-
-
1.8
Other (provide details if material)
-
-
1.9
Net cash from / (used in) operating
activities
(11,866
)
(25,238
)
2.
Cash flows from investing
activities
-
-
2.1
Payments to acquire:
(a) entities
(b) businesses
-
-
(c) property, plant and equipment
(379
)
(646
)
(d) investments
-
-
(e) intellectual property
(77
)
(300
)
(f) other non-current assets
-
-
2.2
Proceeds from disposal of:
-
-
(a) entities
(b) businesses
-
-
(c) property, plant and equipment
-
-
(d) investments
-
-
(e) intellectual property
-
-
(f) other non-current assets
-
-
2.3
Cash flows from loans to other
entities
-
-
2.4
Dividends received (see note 3)
-
-
2.5
Other (provide details if material)
-
-
2.6
Net cash from / (used in) investing
activities
(456
)
(946
)
3.
Cash flows from financing
activities
-
120,000
3.1
Proceeds from issues of equity securities
(excluding convertible debt securities)
3.2
Proceeds from issue of convertible debt
securities
-
-
3.3
Proceeds from exercise of options
108
471
3.4
Transaction costs related to issues of
equity securities or convertible debt securities
-
(7,572
)
3.5
Proceeds from borrowings
-
-
3.6
Repayment of borrowings
-
-
3.7
Transaction costs related to loans and
borrowings
-
-
3.8
Dividends paid
-
-
3.9
Other (provide details if material)
489
-
3.10
Net cash from / (used in) financing
activities
597
112,899
4.
Net increase / (decrease) in cash and
cash equivalents for the period
124,658
28,983
4.1
Cash and cash equivalents at beginning of
period
4.2
Net cash from / (used in) operating
activities (item 1.9 above)
(11,866
)
(25,238
)
4.3
Net cash from / (used in) investing
activities (item 2.6 above)
(456
)
(946
)
4.4
Net cash from / (used in) financing
activities (item 3.10 above)
597
112,899
4.5
Effect of movement in exchange rates on
cash held
17,002
14,237
4.6
Cash and cash equivalents at end of
period
129,935
129,935
5.
Reconciliation of cash and cash
equivalents at the end of the
quarter (as shown in the consolidated statement of cash flows) to
the related items in the accounts
Current quarter $A’000
Previous quarter
$A’000
5.1
Bank balances
129,935
124,658
5.2
Call deposits
-
-
5.3
Bank overdrafts
-
-
5.4
Other (provide details)
-
-
5.5
Cash and cash equivalents at end of
quarter (should equal item 4.6 above)
129,935
124,658
6.
Payments to related parties of the
entity and their associates – N/A
Current quarter $A'000
6.1
Aggregate amount of payments to related
parties and their associates included in item 1
913
6.2
Aggregate amount of payments to related
parties and their associates included in item 2
-
6.1 Executive Director remuneration
(825k), Directors fees (77k), and Clinical Advisory Board Fees
(11k)
7.
Financing facilities – N/A
Note: the term “facility’
includes all forms of financing arrangements available to the
entity.
Add
notes as necessary for an understanding of the sources of finance
available to the entity.
Total facility amount at
quarter end $A’000
Amount drawn at quarter end
$A’000
7.1
Loan facilities
-
-
7.2
Credit standby arrangements
-
-
7.3
Other (please specify)
-
-
7.4
Total financing facilities
-
-
7.5
Unused financing facilities
available at quarter end
-
7.6
Include in the box below a description of
each facility above, including the lender, interest rate, maturity
date and whether it is secured or unsecured. If any additional
financing facilities have been entered into or are proposed to be
entered into after quarter end, include a note providing details of
those facilities as well.
N/A
8.
Estimated cash available for future
operating activities
$A’000
8.1
Net cash from / (used in) operating
activities (Item 1.9)
(11,866
)
8.2
Cash and cash equivalents at quarter end
(Item 4.6)
129,935
8.3
Unused finance facilities available at
quarter end (Item 7.5)
-
8.4
Total available funding (Item 8.2 + Item
8.3)
129,935
8.5
Estimated quarters of funding available
(Item 8.4 divided by Item 8.1)
11
8.6
If Item 8.5 is less than 2 quarters,
please provide answers to the following questions:
1. Does the entity expect that it
will continue to have the current level of net operating cash flows
for the time being and, if not, why not?
Answer: N/A
2. Has the entity taken any
steps, or does it propose to take any steps, to raise further cash
to fund its operations and, if so, what are those steps and how
likely does it believe that they will be successful?
Answer: N/A
3. Does the entity expect to be
able to continue its operations and to meet its business objectives
and, if so, on what basis?
Answer: N/A
Compliance statement
1 This statement has been prepared in accordance with accounting
standards and policies which comply with Listing Rule 19.11A.
2 This statement gives a true and fair view of the matters
disclosed.
Date: 4/29/2020
Authorised by: David McIntyre
(Name of body or officer authorising release – see note 4)
Notes
- This quarterly cash flow report and the accompanying activity
report provide a basis for informing the market about the entity’s
activities for the past quarter, how they have been financed and
the effect this has had on its cash position. An entity that wishes
to disclose additional information over and above the minimum
required under the Listing Rules is encouraged to do so.
- If this quarterly cash flow report has been prepared in
accordance with Australian Accounting Standards, the definitions
in, and provisions of, AASB 107: Statement of Cash Flows apply to
this report. If this quarterly cash flow report has been prepared
in accordance with other accounting standards agreed by ASX
pursuant to Listing Rule 19.11A, the corresponding equivalent
standard applies to this report.
- Dividends received may be classified either as cash flows from
operating activities or cash flows from investing activities,
depending on the accounting policy of the entity.
- If this report has been authorised for release to the market by
your board of directors, you can insert here: “By the board”. If it
has been authorised for release to the market by a committee of
your board of directors, you can insert here: “By the [name of
board committee – eg Audit and Risk Committee]”. If it has been
authorised for release to the market by a disclosure committee, you
can insert here: “By the Disclosure Committee”.
- If this report has been authorised for release to the market by
your board of directors and you wish to hold yourself out as
complying with recommendation 4.2 of the ASX Corporate Governance
Council’s Corporate Governance Principles and Recommendations, the
board should have received a declaration from its CEO and CFO that,
in their opinion, the financial records of the entity have been
properly maintained, that this report complies with the appropriate
accounting standards and gives a true and fair view of the cash
flows of the entity, and that their opinion has been formed on the
basis of a sound system of risk management and internal control
which is operating effectively.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200428006111/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
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