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September 18,
2019
Michael Perry
Chief Executive Officer
Avita Medical Limited
Level 7, 330 Collins Street
Melbourne VIC 3000 Australia
Re: Avita Medical Limited
Amendment No. 2 to Draft Registration Statement on Form 20-F
Submitted September 11, 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
September 9, 2019 letter.
Draft Registration Statement on Form 20-F
We have limited experience manufacturing..., page 3
1. Your response to prior comment 1 indicates that you work with "a number"
of third-party
manufactures, "several" of which you have identified in this risk
factor. Please tell us if
you have named all material third-party manufacturers that are the
subject of this risk
factor in order for investors to evaluate the risk, or revise your
disclosure as appropriate.
BARDA Contract, page 35
2. Please briefly describe any of the material terms of Articles H.2 and
H.20 of the
agreements filed as Exhibits 4.3 and 4.4. If there are any material
march-in rights, address
Michael Perry
FirstName LastNameMichael Perry
Avita Medical Limited
Comapany 18, 2019 Medical Limited
September NameAvita
September 18, 2019 Page 2
Page 2
FirstName LastName
the portion of your business that would be affected by exercise of
such rights, and
describe the conditions which might prompt the U.S. government to
exercise any
such rights. Include risk factor disclosure if appropriate.
Research and Development, page 35
3. Our prior comment 3 requested that you include appropriate risk factor
disclosure if you
rely on third parties' expertise, personnel, testing facilities or
their transferring any
intellectual property rights associated with their efforts. Your
response to prior comment
3 indicates that you "routinely" contract with major contract research
organizations and
your disclosure on page 50 indicates that your research and
development expenses consist
primarily of expenses for contracted research and development
activities conducted on
your behalf. Given your disclosure, it is not clear the extent to
which you rely on contract
research organizations in general for your research and development
activities and why
risk factor disclosure would not be appropriate so that investors can
evaluate the risks to
your business if you rely on third-parties for a material portion of
your research and
development activities and if you do not currently have the in-house
capabilities to replace
the services those third-parties provide. Please advise or revise your
disclosure as
appropriate.
Management's Discussion and Analysis of Results of Operations, page 44
4. We note your response to prior comment 7 and your revised disclosure
on page 44. It is
still unclear how you have revised your disclosure to provide a
narrative discussion of the
extent to which changes in sales of goods are attributable to changes
in prices or to
changes in the volume or amount of products or services being sold or
to the introduction
of new products or services, as requested by prior comment 10 of our
letter dated August
15, 2019. It also is still unclear how you have revised your
disclosure to discuss the
causes of material changes to the extent necessary for an
understanding of your business
as a whole, as requested by prior comment 12 of our letter dated
August 15, 2019. Please
revise to provide those disclosures.
Compensation, page 54
5. We note your response to prior comment 10, but note that your heading
to Table 2
indicates you are providing "Remuneration for the year ended June 30,
2018." Please
confirm that you have provided the required disclosure for your last
full financial year and
revise your heading and disclosure in the table as appropriate.
6. With regard to Table 2, please tell us why for Mr. McDonald the amount
in the "Total"
column is not equal to the sum of the individual components or revise
your table as
appropriate.
7. Please revise to provide clear disclosure of which amounts shown in
Table 2 were used as
the numerators for calculating the percentages shown in the last three
columns of that
Michael Perry
Avita Medical Limited
September 18, 2019
Page 3
table and provide us with a response that shows us how you have
calculated those
percentages.
Financial Information, page 67
8. We note the "Appendix 4E--Preliminary Final Report 30 June 2019"
available on your
website. Given the information in that report, please tell us how you
intend to comply
with the third sentence from the end of Item 8.A.5 of Form 20-F. If you
make financial
information available to investors in your home market or on your
website that may not be
required to be reported under U.S. federal securities laws until a later
date or at all, please
include appropriate risk factor disclosure.
Item 19. Exhibits, page II-3
9. We note your first risk factor on page 9; please file as exhibits to
your registration
statement your agreements with the suppliers upon which your business is
substantially
dependent.
10. We note your statement on the first pages of Exhibits 4.3, 4.4, 4.5, 4.6
and 4.7. If you
intend to rely on the procedures in Instruction 4 of the "Instructions
as to Exhibits" section
of Form 20-F, as indicated by that Instruction, please revise to mark
each applicable
exhibit to indicate, if true, that portions of the exhibit have been
omitted and include a
prominent statement on the first page of each redacted exhibit that
certain identified
information has been excluded from the exhibit because it is both (i)
not material and (ii)
would likely cause competitive harm to the registrant if publicly
disclosed. If instead you
intend to submit a separate confidential treatment request, please
submit that request so
that we can evaluate that request.
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 Geoff
Kruczek, Special
Counsel, at (202) 551-3641 with any other questions.
Sincerely,
FirstName LastNameMichael Perry
Division of
Corporation Finance
Comapany NameAvita Medical Limited
Office of
Electronics and Machinery
September 18, 2019 Page 3
cc: Christopher H. Cunningham, Esq.
FirstName LastName