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AVITA Medical, Inc.
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AVITA Medical, Inc.
Response Received
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SEC wrote to company
2023-04-18
AVITA Medical, Inc.
Summary
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AVITA Medical, Inc.
Awaiting Response
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Medium
SEC wrote to company
2021-03-19
AVITA Medical, Inc.
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AVITA Medical, Inc.
Response Received
1 company response(s)
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SEC wrote to company
2021-02-10
AVITA Medical, Inc.
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Company responded
2021-02-19
AVITA Medical, Inc.
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AVITA Medical, Inc.
Response Received
1 company response(s)
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AVITA Medical, Inc.
Awaiting Response
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SEC wrote to company
2019-09-30
AVITA Medical, Inc.
Summary
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AVITA Medical, Inc.
Response Received
2 company response(s)
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SEC wrote to company
2019-09-24
AVITA Medical, Inc.
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Company responded
2019-09-26
AVITA Medical, Inc.
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AVITA Medical, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2019-09-18
AVITA Medical, Inc.
References: August
15, 2019 | August 15, 2019
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Company responded
2019-09-19
AVITA Medical, Inc.
References: August 15, 2019
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AVITA Medical, Inc.
Awaiting Response
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Medium
SEC wrote to company
2019-09-10
AVITA Medical, Inc.
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AVITA Medical, Inc.
Awaiting Response
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Medium
SEC wrote to company
2019-08-15
AVITA Medical, Inc.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-07 | Company Response | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2026-04-06 | SEC Comment Letter | AVITA Medical, Inc. | DE | 333-294790 | Read Filing View |
| 2023-04-21 | Company Response | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2023-04-18 | SEC Comment Letter | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2021-03-19 | SEC Comment Letter | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2021-02-19 | Company Response | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2021-02-10 | SEC Comment Letter | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2020-10-15 | Company Response | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2020-10-15 | SEC Comment Letter | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2019-09-30 | SEC Comment Letter | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2019-09-26 | Company Response | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2019-09-25 | Company Response | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2019-09-24 | SEC Comment Letter | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2019-09-19 | Company Response | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2019-09-18 | SEC Comment Letter | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2019-09-10 | SEC Comment Letter | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2019-08-15 | SEC Comment Letter | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-06 | SEC Comment Letter | AVITA Medical, Inc. | DE | 333-294790 | Read Filing View |
| 2023-04-18 | SEC Comment Letter | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2021-03-19 | SEC Comment Letter | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2021-02-10 | SEC Comment Letter | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2020-10-15 | SEC Comment Letter | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2019-09-30 | SEC Comment Letter | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2019-09-24 | SEC Comment Letter | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2019-09-18 | SEC Comment Letter | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2019-09-10 | SEC Comment Letter | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2019-08-15 | SEC Comment Letter | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-07 | Company Response | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2023-04-21 | Company Response | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2021-02-19 | Company Response | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2020-10-15 | Company Response | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2019-09-26 | Company Response | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2019-09-25 | Company Response | AVITA Medical, Inc. | DE | N/A | Read Filing View |
| 2019-09-19 | Company Response | AVITA Medical, Inc. | DE | N/A | Read Filing View |
2026-04-07 - CORRESP - AVITA Medical, Inc.
CORRESP
1
filename1.htm
CORRESP
28159 Avenue Stanford, Suite 220, Valencia, CA 91355
T (833) 462-8482 W AVITAmedical.com
April 7, 2026
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention: Nicholas O’Leary
Re:
AVITA Medical, Inc.
Registration Statement on Form S-3
Filed on March 31, 2026
File No. 333-294790
Ladies and Gentlemen:
Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), registrant AVITA Medical, Inc. (the “Registrant”) hereby respectfully requests that the above-referenced Registration Statement on Form S-3 be declared effective at 4:30 p.m., Eastern Time, on April 9, 2026 or as soon thereafter as is practicable, or at such later time as the Registrant or its counsel may orally request via telephone call to the staff of the Commission.
Please direct any questions regarding this request to Coleman Wombwell of K&L Gates LLP ((704) 331-7551; coleman.wombwell@klgates.com). In addition, please notify Mr. Wombwell when this request for acceleration has been granted.
Sincerely,
/s/ Nicole Kelsey
Nicole Kelsey
Chief Legal and Compliance Officer
AVITA Medical, Inc.
2026-04-06 - UPLOAD - AVITA Medical, Inc. File: 333-294790
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 6, 2026 Cary Vance Interim Chief Executive Officer AVITA Medical, Inc. 28159 Avenue Stanford Suite 220 Valencia, CA 91355 Re: AVITA Medical, Inc. Registration Statement on Form S-3 Filed March 31, 2026 File No. 333-294790 Dear Cary Vance: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Nicholas O'Leary at 202-551-4451 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Coleman Wombwell, Esq. </TEXT> </DOCUMENT>
2023-04-21 - CORRESP - AVITA Medical, Inc.
CORRESP 1 filename1.htm CORRESP AVITA Medical, Inc. 28159 Stanford Avenue, Suite 220 Valencia, California 91355 April 21, 2023 Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Nicholas O’Leary Re: AVITA Medical, Inc. Registration Statement on Form S-3 Filed on April 14, 2023 File No. 333-271276 Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), registrant AVITA Medical, Inc. (the “Registrant”) hereby respectfully requests that the above-referenced Registration Statement on Form S-3 be declared effective at 4:30 p.m., Eastern Time, on April 25, 2023 or as soon thereafter as is practicable, or at such later time as the Registrant or its counsel may orally request via telephone call to the staff of the Commission. Please direct any questions regarding this request to Christopher H. Cunningham of K&L Gates LLP ((206) 370-7639; chris.cunningham@klgates.com). In addition, please notify Mr. Cunningham when this request for acceleration has been granted. We understand that the staff of the United States Securities and Exchange Commission will consider this request as confirmation by the Registrant that it is aware of its responsibilities under the Securities Act as they relate to the issuance of the securities covered by the Registration Statement. Sincerely, /s/ Sean Ekins Sean Ekins Interim Chief Financial Officer AVITA Medical, Inc.
2023-04-18 - UPLOAD - AVITA Medical, Inc.
United States securities and exchange commission logo
April 18, 2023
Sean Ekins
Chief Financial Officer
AVITA Medical, Inc.
28159 Avenue Stanford, Suite 220
Valencia, CA 91355
Re:AVITA Medical, Inc.
Registration Statement on form S-3
Filed on April 14, 2023
File No. 333-271276
Dear Sean Ekins:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Nicholas O'Leary at (202) 551-4451 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: Christopher Cunningham
2021-03-19 - UPLOAD - AVITA Medical, Inc.
United States securities and exchange commission logo
March 19, 2021
Sean Ekins
VP of Finance
AVITA Medical, Inc.
28159 Avenue Stanford
Suite 220
Valencia, CA 91355
Re:AVITA Medical, Inc.
Form 10-K for the fiscal year ended June 30, 2020
Filed August 27, 2020
File No. 1-39059
Dear Mr. Ekins:
We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2021-02-19 - CORRESP - AVITA Medical, Inc.
CORRESP 1 filename1.htm CORRESP February 19, 2021 U.S. Securities and Exchange Commission (“Commission” or “Staff”) Attn: Jenn Do and Vanessa Robertson Division of Corporation Finance Office of Life Sciences Washington, DC 20549 Re: Avita Medical, Inc. Form 10-K for the Fiscal Year ended June 30, 2020 Filed August 27, 2020 File No. 1-39059 Dear Ms. Do and Ms. Robertson: Reference is made to the letter received from the Commission dated February 10, 2021 regarding the Form 10-K for the fiscal year ended June 30, 2020 (the “10-K”) of Avita Medical, Inc. (the “Company”). For your convenience, we have included your comments in this response letter in bold form and keyed our response accordingly. The Company’s response to the comments is as follows. Form 10-K for the fiscal year ended June 30, 2020 Item 9A. Controls and Procedures, page 49 Comment: 1. Please amend the 10-K to revise Management’s Report on Internal Control over Financial Reporting to specifically state whether or not the internal control over financial reporting was effective as of June 30, 2020. Your current disclosure refers to disclosure controls and procedures, which is separately assessed under “Evaluation of Disclosure Controls and Procedures”. Include updated management certifications as required. Response: We acknowledge the comment of the Staff, change in terminology was an inadvertent administrative error. The Company will amend the 10-K to revise Management’s Report on Internal Control over Financial Reporting to specifically state that the internal control over financial reporting was effective as of June 30, 2020. We will also include updated management certifications. Consolidated Statements of Operations, page F-4 Comment: 2. Please tell us how your presentation of a separate line item for stock-based compensation complies with SAB Topic 14F. Avita Medical, Inc. 28159 Avenue Stanford, Suite 220 Valencia, CA 91355 P +1 (661) 367-9170 | f +1 (661) 367-9180 | avitamedical.com Page Two Response: The Company’s considerations for selected presentation of share-based compensation as its own line item are set forth below: 1. Historical Presentation—The Company has historically presented share-based compensation expense as a separate line item in the consolidated statement of operations, including in 2020 Annual Reports on Form 10-K for twelve months ended June 30, 2020, 2019 and 2018 and in its Quarterly Report on Form 10-Q the three months ended September 30, 2020. Further, as a foreign filer, the Company presented share-based compensation as its own financial statement line-item in the Annual Report on Form 20-F for the year ended June 30, 2019, which was filed with the Securities and Exchange Commission on October 31, 2019. As part of the redomiciliation the Company obtained relief from ASIC filing requirements. Given the large investor base, the Company strived to have a filing that meet the needs of the Australian investors while maintaining compliance with US GAAP and SEC filing requirements. 2. Needs of financial statement users concerning the disclosure of total share-based compensation expense – Given the growth stage of the Company, including early commercialization with historical net operating losses, management determined that the users of the financial statements (investors and financial analysts) are primarily concerned with the Company’s revenue growth, the Company’s future pipeline and the cash burn rate. As such, given the significance of the share-based compensation expense in relation to other operating expenses, the Company determined that separate classification in its own line item would be more meaningful to the users of the financial statements. 3. Classification – In evaluating the grants and the related expense, the awards are primarily related to the CEO and other executive officers. Compensation related to the executive positions is primarily presented in general and administrative expenses. Although this point is not explicitly stated in the financial statements, it can be obtained through a combination of information in our 10-K (Item 8 Financial Statements and Supplementary Data, Item 11 Executive Compensation, and Item 12 Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters) along with information disclosed in Form 3 and Form 4 filings. Materiality Assessment We considered whether the departure from the presentation promulgated by SAB Topic 14F resulted in a material misstatement in the Company’s previously issued consolidated financial statements. In making our assessment, we considered the qualitative factors in SAB 99 concerning whether a misstatement could be material by a user of the financial statements. Specifically, we evaluated whether the presentation of share-based compensation on its own line in the Consolidated Statement of Operations could have impacted the achievement of bonus targets or market guidance, or on the Company’s compliance with loan covenants or other contractual requirements. Based on our qualitative assessment, we did not identify factors which would lead management to conclude that the departure from the presentation required by SAB Topic 14F resulted in a material misstatement of the Company’s previously issued financial statements. The Company believes it is acceptable to conform the presentation of share-based compensation expense to the SAB Topic 14F guidance in its prospective period SEC filings beginning with Quarterly Report on Form 10-Q for the quarter ended December 31, 2020. Prior period presentation of the Statement of Operations will be updated to conform to the current period presentation, and disclosure will be added to Note 2 of the financial statements which highlights the reclassification of prior year amounts along with adding a table so that the readers of the financial statements can identify the impact of share-based compensation on each line of its Consolidated Statement of Operations. The Company has properly disclosed such reclassification of previously reported amounts in the second quarter ended December 31, 2020. Avita Medical, Inc. 28159 Avenue Stanford, Suite 220 Valencia, CA 91355 P +1 (661) 367-9170 | f +1 (661) 367-9180 | avitamedical.com Page Three Should you have any questions or wish to discuss the foregoing in further detail, please feel free to contact us. Sincerely, Avita Medical Limited By /s/ Sean Ekins Sean Ekins, Interim Principal Financial and Accounting Officer Avita Medical, Inc. 28159 Avenue Stanford, Suite 220 Valencia, CA 91355 P +1 (661) 367-9170 | f +1 (661) 367-9180 | avitamedical.com
2021-02-10 - UPLOAD - AVITA Medical, Inc.
United States securities and exchange commission logo
February 10, 2021
Sean Ekins
VP of Finance
AVITA Medical, Inc.
28159 Avenue Stanford
Suite 220
Valencia, CA 91355
Re:AVITA Medical, Inc.
Form 10-K for the fiscal year ended June 30, 2020
Filed August 27, 2020
File No. 1-39059
Dear Mr. Ekins:
We have limited our review of your filing to the financial statements and related
disclosures 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 these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Form 10-K for the fiscal year ended June 30, 2020
Item 9A. Controls and Procedures, page 49
1.Please amend the 10-K to revise Management's Report on Internal Control over Financial
Reporting to specifically state whether or not the internal control over financial reporting
was effective as of June 30, 2020. Your current disclosure refers to disclosure controls
and procedures, which is separately assessed under "Evaluation of Disclosure Controls
and Procedures". Include updated management certifications as required.
Consolidated Statements of Operations, page F-4
2.Please tell us how your presentation of a separate line item for stock-based compensation
complies with SAB Topic 14F.
FirstName LastNameSean Ekins
Comapany NameAVITA Medical, Inc.
February 10, 2021 Page 2
FirstName LastName
Sean Ekins
AVITA Medical, Inc.
February 10, 2021
Page 2
In closing, we remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
You may contact Jenn Do at (202) 551-3743 or Vanessa Robertson at (202) 551-
3649 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2020-10-15 - CORRESP - AVITA Medical, Inc.
CORRESP 1 filename1.htm CORRESP October 15, 2020 VIA EDGAR United States Securities and Exchange Commission Division of Corporate Finance 100 F Street, N.E. Washington, DC 20549-4628 Re: Avita Therapeutics, Inc. (the “Company”) Registration Statement on Form S-3 Filed October 9, 2020 File No. 333-249419 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, Avita Therapeutics, Inc. (the “Company”) hereby requests that the effectiveness of the above-captioned Registration Statement be accelerated to October 16, 2020, at 4:00 p.m., Washington, D.C. time, or as soon thereafter as practicable. The Company hereby acknowledges that: 1. Should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; 2. The action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and 3. The Company may not assert this action as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. If you have any questions, or require any additional information, please do not hesitate to call Christopher H. Cunningham at K&L Gates LLP, the Company’s primary outside counsel, at (206) 370-7639. Very truly yours, Avita Therapeutics, Inc. Donna Shiroma General Counsel cc: Christopher H. Cunningham, K&L Gates LLP
2020-10-15 - UPLOAD - AVITA Medical, Inc.
United States securities and exchange commission logo
October 15, 2020
Donna Shiroma
General Counsel
Avita Therapeutics, Inc.
28159 Avenue Stanford, Suite 220
Valencia, CA 91355
Re:Avita Therapeutics, Inc.
Registration Statement on Form S-3
Filed October 9, 2020
File No. 333-249419
Dear Ms. Shiroma:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact James Young at 202-551-4679 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Christopher Cunningham
2019-09-30 - UPLOAD - AVITA Medical, Inc.
September 27, 2019
Michael Perry
Chief Executive Officer
Avita Medical Limited
Level 7, 330 Collins Street
Melbourne VIC 3000 Australia
Re:Avita Medical Limited
Registration Statement on Form 20-F
Filed September 19, 2019
File No. 001-39059
Dear Dr. Perry:
We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Electronics and Machinery
cc: Christopher H. Cunningham, Esq.
2019-09-26 - CORRESP - AVITA Medical, Inc.
CORRESP 1 filename1.htm CORRESP AVITA MEDICAL LTD. Level 7, 330 Collins Street Melbourne VIC 3000 Australia September 26, 2019 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Avita Medical Limited (CIK No. 0001762303) Registration Statement on Form 20-F Initially Submitted July 19, 2019 File No. 001-39059 Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), Avita Medical Limited (the “Company”) hereby respectfully requests acceleration of the effective date of the Company’s registration statement on Form 20-F, initially submitted to the U.S. Securities and Exchange Commission (the “Commission”) on July 19, 2019 and filed with the Commission on September 19, 2019 (as amended, the “20-F Registration Statement”), so that it may become effective at 4:00 p.m., Eastern Time, on September 27, 2019, or as soon thereafter as practicable. The Company understands that The Bank of New York Mellon, as Depositary, has requested that the registration statement on Form F-6, submitted to the Commission on September 19, 2019 (File No.: 333-233853) be declared effective concurrently with the 20-F Registration Statement, and pursuant to Rule 461 promulgated under the Securities Act, the Company concurs with that request. Should any member of the staff of the Commission have any questions or comments with respect to this request, please contact me at 661-367-9161 or via e-mail at troony@avitamedical.com or our outside legal counsel from K&L Gates, LLP, Christopher Cunningham at 206-370-7639 or via email at chris.cunningham@klgates.com. The Company hereby authorizes each of Mr. Rooney and Mr. Cunningham (and either one of them) to orally modify or withdraw this request for acceleration. Respectfully, Avita Medical Limited By: /s/ Timothy Rooney Name: Timothy Rooney Title: Acting Chief Financial Officer cc: Christopher Cunningham (K&L Gates LLP) Jonathan Miner (K&L Gates LLP)
2019-09-25 - CORRESP - AVITA Medical, Inc.
CORRESP
1
filename1.htm
CORRESP
September 25, 2019
U.S. Securities and Exchange Commission (“Commission” or “Staff”)
c/o Mr. Tim Buchemiller and Mr. Russell Mancuso
Division of Corporation Finance
Office of Electronics and
Machinery
Washington, DC 20549
Re:
Avita Medical Limited
Registration Statement on Form 20-F
Filed September 19, 2019
Commission Fine Number 001-39059
Dear Mr. Buchemiller and Mancuso:
Reference is made to the letter received from the Commission dated September 24, 2019 regarding the Registration Statement on Form 20-F (the “Form 20-F”) of Avita Medical Limited (the “Company”).
For your convenience, we have included your comments in this response letter in bold form and keyed our response accordingly. The
Company’s response to the comments is as follows.
Registration Statement on Form 20-F filed
September 19, 2019
Key Information, page 2
Comment:
1.
We note your response to prior comment 8, and your disclosure added on pages 4, 46 and 95 that the
information in exhibit 15.1 should not be relied on as indicative of actual results for the year ended June 30, 2019. You may not disclaim responsibility for your disclosure; please revise to remove any implication to the contrary. Also:
•
If the exhibit is not intended to be indicative of actual results, clarify the purpose of the report included
as an exhibit, including what it is intended to indicate.
•
Please be advised that you are responsible for considering whether additional disclosures of material
information regarding your results are required to make the statements in your filing not misleading.
Response
We have revised the disclosure on pages 4, 46 and 95 to remove such references and only include a note that such information contained in
Exhibit 15.1 is unaudited.
General
Comment:
2.
Please ensure that your disclosure is current. We note for example your September 17, 2019 press release.
Response:
We have revised the disclosure, specifically on page 35, to reflect any material information contained in such recent press releases.
Should you have any questions or wish to discuss the foregoing in further detail, please feel free to contact us.
Sincerely,
Avita Medical Limited
By
/s/ Timothy Rooney
Timothy Rooney, Chief Administrative Officer
and Acting Chief Financial Officer
2019-09-24 - UPLOAD - AVITA Medical, Inc.
September 24, 2019
Michael Perry
Chief Executive Officer
Avita Medical Limited
Level 7, 330 Collins Street
Melbourne VIC 3000 Australia
Re:Avita Medical Limited
Registration Statement on Form 20-F
Filed September 19, 2019
File No. 001-39059
Dear Dr. Perry:
We have reviewed your filing 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 these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
After reviewing your response and any amendment you may file in response to these
comments, we may have additional comments. Unless we note otherwise, our references to prior
comments are to comments in our September 18, 2019 letter.
Registration Statement on Form 20-F filed September 19, 2019
Key Information, page 2
1.We note your response to prior comment 8, and your disclosure added on pages 4, 46 and
95 that the information in exhibit 15.1 should not be relied on as indicative of actual
results for the year ended June 30, 2019. You may not disclaim responsibility for your
disclosure; please revise to remove any implication to the contrary. Also:
•If the exhibit is not intended to be indicative of actual results, clarify the purpose of
the report included as an exhibit, including what it is intended to indicate.
•Please be advised that you are responsible for considering whether additional
disclosures of material information regarding your results are required to make the
statements in your filing not misleading.
FirstName LastNameMichael Perry
Comapany NameAvita Medical Limited
September 24, 2019 Page 2
FirstName LastName
Michael Perry
Avita Medical Limited
September 24, 2019
Page 2
General
2.Please ensure that your disclosure is current. We note for example your September 17,
2019 press release.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
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,
Division of Corporation Finance
Office of Electronics and Machinery
cc: Christopher H. Cunningham, Esq.
2019-09-19 - CORRESP - AVITA Medical, Inc.
CORRESP 1 filename1.htm CORRESP September 19, 2019 U.S. Securities and Exchange Commission (“Commission” or “Staff”) c/o Mr. Tim Buchemiller and Mr. Russell Mancuso Division of Corporation Finance Office of Electronics and Machinery Washington, DC 20549 Re: Avita Medical Limited Amendment No. 2 to Draft Registration Statement on Form 20-F Submitted September 11, 2019 CIK No. 0001762303 Dear Mr. Buchemiller and Mancuso: Reference is made to the letter received from the Commission dated September 18, 2019 regarding the confidentially submitted draft Amendment No. 2 to Registration Statement on Form 20-F (the “Form 20-F”) of Avita Medical Limited (the “Company”). For your convenience, we have included your comments in this response letter in bold form and keyed our response accordingly. The Company’s response to the comments is as follows. Draft Registration Statement on Form 20-F We have limited experience manufacturing..., page 3 Comment: 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. Response: The Company has included in the list of third-party manufacturers the Company’s material third-party manufacturers. BARDA Contract, page 35 Comment: 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 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. Response: We have reviewed the terms of Articles H.2 and H.20 of the agreements filed as Exhibits 4.3 and 4.4 (the “BARDA” contracts) and have determined that there are no U.S. government march-in rights that would have a material effect on our business. The BARDA contracts primarily funded clinical studies, and under Articles H.2 and H.20, we would have an obligation to provide the U.S. government with documentation, protocols, data generated from the execution of these protocols, and final reports related to the clinical trials that BARDA helped fund. Provision of such items to the U.S. government would not impact our ability to continue to market and sell our RECELL system and would thus not have a material impact on our business. Research and Development, page 35 Comment: 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. Response: We have revised the 20-F to include a risk factor relating to the Company’s outsourcing of certain research and development activities relating to contract research organizations. Management’s Discussion and Analysis of Results of Operations, page 44 Comment: 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. Response: We have revised the disclosure on page 46 accordingly to further disclose that the Company’s key revenue growth driver is adoption of its RECELL System, as opposed to pricing for such a system. Compensation, page 54 Comment: 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. Response: We have revised the introduction to the table accordingly to indicate the remuneration data provided is for the year ended June 30, 2019. Comment: 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. Response: We have revised the table to correct an error with respect to Mr. McDonald’s total compensation. Comment: 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 table and provide us with a response that shows us how you have calculated those percentages. Response: We have revised the table and as well inserted additional footnote disclosure to indicate how the percentages were established, including an example. Financial Information, page 67 Comment: 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. Response: We have included the preliminary full year results as filed in Australia as an exhibit to the 20-F. In addition, we have provided cross references within the document together with cautionary language regarding the preliminary nature of such results. Following its proposed listing on the Nasdaq Stock Market, we intend to provide current reports on Form 6-K to disclose to the U.S. market any financial information that is made available in our home market or on our website, accordingly we have not included a risk factor related to this. Item 19. Exhibits, page II-3 Comment: 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. Response: Per Instruction to Exhibits Item 4(a) of Form 20-F, the Company is not substantially dependent on these agreements and submits to the Staff that they were entered into in the ordinary course of business; accordingly, the Company submits that they need not be included as Material Contracts. 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. Response: We have revised each of these Exhibits with such language. We do not intend to submit a separate confidential treatment request. Should you have any questions or wish to discuss the foregoing in further detail, please feel free to contact us. Sincerely, Avita Medical Limited By /s/ Timothy Rooney Timothy Rooney, Chief Administrative Officer and Acting Chief Financial Officer
2019-09-18 - UPLOAD - AVITA Medical, Inc.
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
FirstName LastNameMichael Perry
Comapany NameAvita Medical Limited
September 18, 2019 Page 2
FirstName LastNameMichael Perry
Avita Medical Limited
September 18, 2019
Page 2
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
FirstName LastNameMichael Perry
Comapany NameAvita Medical Limited
September 18, 2019 Page 3
FirstName LastName
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,
Division of Corporation Finance
Office of Electronics and Machinery
cc: Christopher H. Cunningham, Esq.
2019-09-10 - UPLOAD - AVITA Medical, Inc.
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.
FirstName LastNameMichael Perry
Comapany NameAvita Medical Limited
September 9, 2019 Page 2
FirstName LastName
Michael Perry
Avita Medical Limited
September 9, 2019
Page 2
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
FirstName LastNameMichael Perry
Comapany NameAvita Medical Limited
September 9, 2019 Page 3
FirstName LastName
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,
Division of Corporation Finance
Office of Electronics and Machinery
cc: Christopher H. Cunningham, Esq.
2019-08-15 - UPLOAD - AVITA Medical, Inc.
August 15, 2019
Michael Perry
Chief Executive Officer
Avita Medical Limited
Level 7, 330 Collins Street
Melbourne VIC 3000 Australia
Re:Avita Medical Limited
Draft Registration Statement on Form 20-F
Submitted July 19, 2019
CIK No. 0001762303
Dear Dr. Perry:
We have reviewed your 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.
Draft Registration Statement on Form 20-F
General
1.Please ensure that your disclosure is current. For example, we note your reference to "the
first half of 2019" on page 14, "mid 2019" on page 31, May 2019 on page 32, and "the
first half of 2019" on page 67.
Risk Factors, page 5
2.Your reference at the top of page 70 to uncalled capital suggests that a portion of your
capital may be subject to calls. If so, please add an appropriate risk factor. Also please
describe in an appropriate risk factor the risk related to your quorum requirements and
voting on a show of hands mentioned on pages 70-71.
FirstName LastNameMichael Perry
Comapany NameAvita Medical Limited
August 15, 2019 Page 2
FirstName LastName
Michael Perry
Avita Medical Limited
August 15, 2019
Page 2
We have limited experience manufacturing..., page 9
3.Please provide us your analysis of whether you must name the third-party manufacturers
that are the subject of this risk factor for investors to adequately evaluate the risk.
The RECELL System, page 23
4.Refer to the last sentence of the first full paragraph on page 24 and your disclosure in the
last sentence under the heading "Additional RECELL Clinical Results in Severe Burns"
on page 28. Please see footnote 41 and the related text of Release No. 34-42728 (April
28, 2000) regarding your responsibility when including a URL in your document,
including the obligation to file the linked information as part of your document.
The RECELL System Clinical Results and Ongoing and Planned Clinical Trials, page 24
5.Where your have not already done so, please clarify which trials, if successful, you
intend to be sufficient to support an application for regulatory clearance to market
your product for the disclosed indications in the United States without additional trials.
Also, please revise the second paragraph of your disclosure under the heading "BARDA
Contract" on page 34 to clarify which of the referenced studies are complete, which have
begun, and which have not begun.
Research and Development, page 34
6.We note your disclosure in the last sentence on page 48 that your research and
development expenses consist primarily of expenses for contracted research and
development conducted by third parties on your behalf. Please revise the disclosure in
this section to clarify the extent to which your activities rely upon the efforts of third
parties. Include risk factor disclosure as appropriate.
FDA and International Regulation, page 37
7.Please clarify why you cannot be certain that you comply with cGMP and other FDA and
international agency and regulatory requirements as mentioned in the last sentence of the
second full paragraph on page 38. Likewise, please clarify why laws, regulations and
permits could require expenditure of significant amounts and why you may be identified
as a potential responsible party as mentioned on page 39; it is unclear from your existing
disclosure whether you are aware of violations or deficiencies.
8.Please clarify whether applicable laws and regulations permit you to fill purchase requests
in the EU given the non-conformities that you mention in the last paragraph of this
section.
FirstName LastNameMichael Perry
Comapany NameAvita Medical Limited
August 15, 2019 Page 3
FirstName LastName
Michael Perry
Avita Medical Limited
August 15, 2019
Page 3
Research and Development Tax Incentive, page 42
9.Please describe how your operations or the incentive have changed such that you did not
record any amount for the first six months of this fiscal year.
Management's Discussion and Analysis of Results of Operations, page 42
10.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.
11.Please tell us whether the margins under the vendor-managed inventory system mentioned
on page 34 are consistent with the margins experienced in your most recent historic period
disclosed in your filing and the expectations mentioned on page 43. Also, in an
appropriate section of your document, clarify when that system is intended to begin
and the period over which the disclosed $7.6 million is intended be received; if you do not
intend to recognize the full amount upon receipt, please clarify.
Year Ended June 30, 2018 compared to Year Ended June 30, 2017, page 43
12.We note your disclosure that the largest increase in sale of goods occurred in Asia
Pacific. Please balance this disclosure with disclosure regarding sale of goods in EMEA.
In that regard, please also disclose management's assessment of factors and trends which
are anticipated to have a material effect on your financial condition and results of
operations. Also discuss the causes of material changes to the extent necessary for an
understanding of your business as a whole.
Liquidity and Capital Resources, page 45
13.We note from your statement of cash flows on pages F-6 and F-55 the "R&D tax refund
received" amounts. Please expand your disclosure to include information regarding this
source of liquidity.
14.We note your reference to credit agreements at the top of page 14. If appropriate, please
include a description of your credit agreements as an external source of liquidity and a
include a brief discussion of any material unused sources of liquidity.
Compensation, page 52
15.Please update your compensation disclosure for the last full financial year. Also, please
clarify how the percentages in the last three columns in the table on page 57 are
calculated; for example, it is unclear why the percentages from Mr. McDonald would
show 0% related to performance and 0% not related to performance.
16.Please show us how you reconcile the total compensation disclosed on page 57 and on
page F-35.
FirstName LastNameMichael Perry
Comapany NameAvita Medical Limited
August 15, 2019 Page 4
FirstName LastNameMichael Perry
Avita Medical Limited
August 15, 2019
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17.Please clarify the nature of the LTIs mentioned on page 57. For example, is each LTI one
ordinary share?
Employees, page 62
18.If possible, please provide a breakdown of persons employed by main category of activity
as required by Form 20-F Item 6.D.
Major Shareholders, page 63
19.Please disclose the natural person or persons who beneficially own the shares held in the
name of the legal entities identified in your table in this section.
Related Party Transactions, page 64
20.Please describe the services provided for the consultancy fees mentioned in this section.
Passive foreign investment company rules, page 78
21.Please clarify why the ordinary shares may not be eligible for mark-to-market treatment
even if the ADSs otherwise satisfy the applicable requirement as mentioned in your fourth
paragraph in this section.
Jury Trial Waiver, page 88
22.We note your reference to a jury trial waiver. Please revise the last sentence of this
section regarding investors not being deemed to have waived compliance with the federal
securities laws to state clearly that investors cannot waive compliance with the federal
securities laws and the rules and regulations promulgated thereunder. Also, (1) include
appropriate risk factor disclosure regarding the risks of the provision, including how it
impacts claims arsing under applicable state and federal laws, and (2) clarify why your
second sentence of this section suggests that there is uncertainty regarding whether a court
would enforce the provision. .
Item 19. Exhibits, page 91
23.Please identify the exhibits that you intend to include with your registration statement.
Report of Independent Registered Accounting Firm, page F-2
24.Please have your auditor revise its opinion paragraph to reference the exact title of the
financial statements included in the filing. For example, the reference to consolidated
balance sheets should be changed to consolidated statement of financial position.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
FirstName LastNameMichael Perry
Comapany NameAvita Medical Limited
August 15, 2019 Page 5
FirstName LastName
Michael Perry
Avita Medical Limited
August 15, 2019
Page 5
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,
Division of Corporation Finance
Office of Electronics and Machinery
cc: Christopher H. Cunningham, Esq.