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September 9, 2019
Michael Perry
Chief Executive Officer
Avita Medical Limited
Level 7, 330 Collins Street
Melbourne VIC 3000 Australia
Re: Avita Medical Limited
Amendment No. 1 to Draft Registration Statement on Form 20-F
Submitted August 23, 2019
CIK No. 0001762303
Dear Dr. Perry:
We have reviewed your amended draft registration statement and have the
following
comments. In some of our comments, we may ask you to provide us with
information so we
may better understand your disclosure.
Please respond to this letter by providing the requested information and
either submitting
an amended draft registration statement or publicly filing your registration
statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances
or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments
and your
amended draft registration statement or filed registration statement, we may
have additional
comments. Unless we note otherwise, our references to prior comments are to
comments in our
August 15, 2019 letter.
Draft Registration Statement on Form 20-F
We have limited experience manufacturing..., page 9
1. We note your response to prior comment 3. However, it remains unclear
how investors
can evaluate the magnitude of the risk represented by your disclosure,
"[i]f...the facilities
of our third-party contract manufacturers, suffers damage, or a force
majeure event, this
could materially impact our ability to operate" if you do not identify
the relevant
manufactures. Please advise or revise.
Michael Perry
FirstName LastNameMichael Perry
Avita Medical Limited
Comapany 9, 2019
September NameAvita Medical Limited
September 9, 2019 Page 2
Page 2
FirstName LastName
Additional RECELL Clinical Results in Severe Burns, page 29
2. Please address prior comment 4 as it applies to the last sentence of
the first paragraph of
this section.
Research and Development, page 35
3. We note your response to prior comment 6. To the extent that you rely
on third parties'
expertise, personnel, testing facilities or their transferring to you
any intellectual property
rights associated with their efforts, please include risk factor
disclosure as appropriate.
FDA and International Regulation, page 38
4. We note your revisions in response to prior comment 8. Please clarify
whether applicable
laws and regulations permitted you to fill purchase requests in the EU
during any periods
of non-conformity.
Environmental, Health and Safety Matters, page 40
5. We note your response to prior comment 7. Please clarify why laws,
regulations and
permits could require expenditures for compliance or remediation and
why you may be
identified as a potential responsible party as mentioned on page 40.
It is unclear from
your existing disclosure whether you are aware of violations or
deficiencies.
Research and Development Tax Incentive, page 44
6. Please include the substance of your response to prior comment 9 in an
appropriate
location.
Management's Discussion and Analysis of Results of Operations, page 44
7. It is unclear where your revised disclosure addresses the issues
mentioned in prior
comment 10 and the last sentence of prior comment 12. Please advise or
revise.
8. Please revise to include the substance of the first two sentences of
your response to prior
comment 11 in an appropriate location.
Liquidity and Capital Resources, page 47
9. We note the disclosure you added in response to prior comment 13. If
the uncertainties
described in your response to prior comment 9 are reasonably likely to
have a material
effect on your liquidity or capital resources, please include
appropriate disclosure.
Compensation, page 53
10. We note your response to the first sentence of prior comment 15;
however, Item 6.B of
Form 20-F requires disclosure for your last full financial year.
Please revise as
Michael Perry
Avita Medical Limited
September 9, 2019
Page 3
appropriate. Also please clarify why, in many cases, the sum of the
percentages for
compensation related to performance and compensation not related to
performance
disclosed in the table on page 58 is less than 100%.
Related Party Transactions, page 66
11. It is unclear where your revisions in response to prior comment 20
describe the services
provided for the consultancy fees mentioned in this section. Please
revise or advise.
Specific powers of Directors, page 71
12. We note your revised disclosure in response to prior comment 2. Please
clarify the
meaning of the directors ability to "charge" "all or any of its
available capital." If any of
the company's capital would not be considered fully paid or
non-assessable, please include
appropriate risk factor disclosure.
Jury Trial Waiver, page 89
13. As requested by our prior comment 22, please revise this section to
state clearly that
investors cannot waive compliance with the federal securities laws and
the rules and
regulations promulgated thereunder.
Exhibits
14. Please expand your response to prior comment 23 to provide us your
analysis of why you
need not file any leases.
You may contact Michael Fay at (202) 551-3812 or Brian Cascio,
Accounting Branch
Chief, at (202) 551-3676 if you have questions regarding comments on the
financial statements
and related matters. Please contact Tim Buchmiller at (202) 551-3635 or Russell
Mancuso,
Legal Branch Chief, at (202) 551-3617 with any other questions.
Sincerely,
FirstName LastNameMichael Perry
Division of
Corporation Finance
Comapany NameAvita Medical Limited
Office of
Electronics and Machinery
September 9, 2019 Page 3
cc: Christopher H. Cunningham, Esq.
FirstName LastName