AVITA Medical, Inc 6-K, filed Jun 22, 2020
AVITA Medical, Inc. (RCEL)
About this 6-K
AVITA Medical, Inc filed this 6-K on June 22, 2020.
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6–K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
June 22, 2020
Commission File Number 001-39059
AVITA MEDICAL LIMITED
(Name of Registrant)
Level 7, 330 Collins Street
Melbourne VIC 3000 Australia
Tel: +61 (0) 3 8689 9997
Fax: +61 (0) 8 9474 7742
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ☐ No ☒
If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-______ .
Table of Contents
AVITA MEDICAL LIMITED
Form 6-K
| Page | ||||
| Page 2 | ||||
| Page 3 | ||||
| Exhibit 99.1 | ||||
Avita Medical Limited (the “Company”) published a news release titled “Proposed redomiciliation to the United States of America—Court approves scheme of arrangement” (the “Public Notice”) to the Australian Securities Exchange on June 22, 2020. A copy of the Public Notice is attached as exhibit 99.1 to this report on Form 6-K.
This report on Form 6-K (including the exhibit hereto) shall not be deemed to be “filed” for purposes of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
2
Table of Contents
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Avita Medical Limited | ||
| By: |
/s/ David McIntyre | |
| Name: |
David McIntyre | |
| Title: |
Chief Financial Officer | |
Date: June 22, 2020
3
Exhibit 99.1
|
ASX/News Release |
AVITA Medical Limited
Proposed redomiciliation to the United States of America—
Court approves scheme of arrangement
Valencia, Calif., USA, and Melbourne, Australia, 22 June 2020: AVITA Medical Limited ACN 058 466 523 (Company) is pleased to announce that the Federal Court of Australia (Court) has today approved the scheme of arrangement to effect a redomiciliation of the Company and its subsidiaries (Avita Group) from Australia to the United States of America (Scheme), under which AVITA Therapeutics, Inc. ARBN 641 288 155 (Avita US), a company incorporated in the State of Delaware in the United States of America, will become the parent company of the Avita Group.
The Company expects to lodge a copy of the Court orders with the Australian Securities and Investments Commission (ASIC) tomorrow (Tuesday, 23 June 2020). Once the orders are registered with ASIC, the Scheme will become effective.
The Company’s shares will be suspended from trading on the ASX from close of trading on Tuesday, 23 June 2020.
The expected timetable for implementation of the Scheme is set out below:
| Event |
Indicative Date | |
| Effective Date for the Scheme
|
23 June 2020 | |
| Listing of Avita US on the ASX
Trading of Avita US Chess Depositary Interests (CDIs) commences on the ASX on a deferred settlement basis |
24 June 2020 | |
| Record Date (for determining the entitlements of shareholders of the Company to Avita US shares or Avita US CDIs) | 7.00pm (AEST) on 25 June 2020 | |
| Last day of trading of the Company’s American Depositary Shares (ADSs) on NASDAQ
Last day of trading of Avita US CDIs on the ASX on a deferred settlement basis |
29 June 2020 | |
| Implementation Date
Issue of Avita US shares or Avita US CDIs to eligible shareholders of the Company |
29 June 2020 | |
| Listing of Avita US on NASDAQ
|
Promptly following the Implementation Date | |
| Trading of Avita US CDIs commences on the ASX on a normal basis | 30 June 2020 | |
1
Avita Medical Limited c/o Mertons Corporate Services Pty Ltd Level 7, 330 Collins Street, Melbourne Victoria 3000
Any changes to the above dates will be announced to the ASX and NASDAQ and via news release, and will also be notified on the Company’s website (www.avitamedical.com).
Authorised for release by the Chief Financial Officer of AVITA Medical Limited.
# # #
ABOUT AVITA MEDICAL LIMITED
AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical’s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a RES® REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.
AVITA Medical’s first U.S. product, the RECELL® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin™ Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 8,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the
INSTRUCTIONS FOR USE—RECELL® Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions.
In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe.
To learn more, visit www.avitamedical.com.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This announcement 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 announcement 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 announcement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the company’s control. Investors should not place considerable reliance on the
2
Avita Medical Limited c/o Mertons Corporate Services Pty Ltd Level 7, 330 Collins Street, Melbourne Victoria 3000
forward-looking statements contained in this announcement. 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 announcement speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.
FOR FURTHER INFORMATION:
| U.S. Media |
Investors: | |
| Sam Brown, Inc.
Christy Curran
Phone +1 615 414 8668
christycurran@sambrown.com |
Westwicke Partners
Caroline Corner
Phone +1 415 202 5678
caroline.corner@westwicke.com | |
| O.U.S Media |
AVITA Medical Ltd | |
| Monsoon Communications
Rudi Michelson
Phone +61 (0)3 9620 3333
Mobile +61 (0)411 402 737
rudim@monsoon.com.au |
David McIntyre
Chief Financial Officer
Phone +1 661 367 9178
dmcintyre@avitamedical.com | |
3
Avita Medical Limited c/o Mertons Corporate Services Pty Ltd Level 7, 330 Collins Street, Melbourne Victoria 3000