Full Press Release Details
Annual Meeting of Stockholders DECEMBER
12, 2022 (PST) / DECEMBER 13, 2022 (AEDT) Exhibit 99.1
Mr. Lou Panaccio, Chairman of the Board
of AVITA Medical, Inc. Call To Order
Brief Company Overview Welcome
Outside the U.S. please call: +1 (781)
575-2748 In the U.S. please call toll free: +1 (888) 724-2416 Experiencing Technical Difficulties?
Procedural Matters Following
Introduction of Directors, Officers, and Advisers
Board of Directors Officers Advisers
Louis (Lou) Panaccio Chair of the Board of Directors Chair of Today's Meeting James (Jim) Corbett Chief Executive Officer and Executive Director Jeremy Curnock-Cook Non-executive Director Professor Suzanne Crowe Non-executive Director Jan
Stern Reed Non-executive Director Michael Holder Chief Financial Officer Donna Shiroma General Counsel Chris Cunningham U.S. Legal Adviser - Partner, K&L Gates LLP David Morris Australian Legal Adviser - Lander & Rogers Breanna
Taylor Australian Legal Adviser - Lander & Rogers Rod Somes Australian Share Registry - Computershare Mark Licciardo Australian local agent- Acclime Australia (Formerly Mertons Corporate Services Pty Ltd.) Representatives
Grant Thornton, LLP Represented by Mark
Bottom Introduction of Independent Registered Public Accounting Firm
Appointment of Inspector of Election
Chairman to appoint Ashleigh Schultz, Computershare US
Notice of Meeting Report By Secretary
Available upon request Presentation
Of List Of Stockholders As Of Record Date
Attendance at this meeting for a
quorum Report Of Quorum
Polls for voting on all matters are
open Proposals - The Board of Directors recommend a vote FOR all of the nominees listed in Proposal 1, and a vote FOR Proposals 2-9 Opening of the Polls and Overview of Voting Proposals
Election of Directors and Approval
of Additional Matters
To elect five directors to serve a
one-year term or until their respective successors have been duly elected and qualified. Louis Panaccio, Chairman of the Board of Directors James Corbett, Executive Director and Chief Executive Officer Jeremy Curnock Cook, Non-Executive Director
Professor Suzanne Crowe, Non-Executive Director Jan Stern Reed, Non-Executive Director Proposal 1: Election of Directors
To ratify the appointment of Grant
Thornton, LLP as the Company's independent public accountants for the fiscal year ending December 31, 2022. Proposal 2:
To amend the Company's
Certificate of Incorporation and Amended and Restated Bylaws to reduce the quorum requirement for stockholder meetings. Proposal 3:
To approve the grant of restricted
stock units to acquire shares of common stock of the Company (which may be represented by CDIs) equal in value to US$87,500 (at the time of the grant) and the grant of options to acquire shares of common stock of the Company (which may be
represented by CDIs) equal in value to US$37,500 (at the time of the grant) to Mr. Louis Panaccio on the terms and conditions set out in this Proxy Statement, pursuant to and for the purposes of ASX Listing Rule 10.11. Proposal 4:
To approve the grant of restricted
stock units to acquire shares of common stock of the Company (which may be represented by CDIs) equal in value to US$87,500 (at the time of the grant) and the grant of options to acquire shares of common stock of the Company (which may be
represented by CDIs) equal in value to US$37,500 (at the time of the grant) to Professor Suzanne Crowe on the terms and conditions set out in this Proxy Statement, pursuant to and for the purposes of ASX Listing Rule 10.11. Proposal 5:
To approve the grant of restricted
stock units to acquire shares of common stock of the Company (which may be represented by CDIs) equal in value to US$87,500 (at the time of the grant) and the grant of options to acquire shares of common stock of the Company (which may be
represented by CDIs) equal in value to US$37,500 (at the time of the grant) to Mr. Jeremy Curnock Cook on the terms and conditions set out in this Proxy Statement, pursuant to and for the purposes of ASX Listing Rule 10.11. Proposal 6:
To approve the grant of restricted
stock units to acquire shares of common stock of the Company (which may be represented by CDIs) equal in value to US$87,500 (at the time of the grant) and the grant of options to acquire shares of common stock of the Company (which may be
represented by CDIs) equal in value to US$37,500 (at the time of the grant) to Ms. Jan Stern Reed on the terms and conditions set out in this Proxy Statement, pursuant to and for the purposes of ASX Listing Rule 10.11. Proposal 7:
To approve the grant of options to
acquire shares of common stock of the Company (which may be represented by CDIs) equal in value to US$1,000,000 (at the time of the grant) to Mr. James Corbett on the terms and conditions set out in this Proxy Statement, pursuant to and for the
purposes of ASX Listing Rule 10.11. Proposal 8:
Advisory vote to approve the
compensation of the Company's named executive officers. Proposal 9:
To transact such other business as
may properly come before the meeting or any adjournment or adjournments thereof. No other business has come before the meeting to be considered at this time. Proposal 10:
The polls are about to close so if
you have not yet voted, please do so. We will announce the results of the voting as soon as possible following the close of this meeting via announcements to be filed with the U.S. Securities and Exchange Commission and the Australian Securities
Exchange. Closing of Polls
The formal business of the meeting
is now closed. We invite you to now ask any questions you may have as it relates to the content of today's meeting. Please follow the instructions provided on the Virtual Meeting Screen. Adjournment of Meeting and General Question and Answer
Conclusion of Annual Meeting of
Certain statements in this
presentation and the accompanying oral commentary are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this
presentation, including statements regarding our future financial condition, technology platform, development strategy, prospective products, pipeline and milestones, regulatory objectives, expected payments from and outcomes of collaborations, and
likelihood of success, are forward-looking statements. Such statements are predictions only and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be
materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, among others, the costs, timing and results of clinical trials and other
development activities; the uncertainties inherent in the initiation and enrollment of clinical trials; the uncertainties associated with the COVID-19 pandemic; the unpredictability of the timing and results of regulatory submissions and reviews;
market acceptance for approved products and innovative therapeutic treatments; competition; the possible impairment of, inability to obtain and costs of obtaining intellectual property rights; and possible safety or efficacy concerns, general
business, financial and accounting risks and litigation. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not
rely on these forward-looking statements as predictions of future events. More information concerning AVITA Medical as well as the aforementioned risks and uncertainties is available in our public filings with the U.S. Securities and Exchange
Commission, including our most recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, and our most recent Transition Report on Form 10-KT period from July 1, 2021 to December 31, 2021. We are providing this information as of
its date and do not undertake any obligation to update or revise it, whether as a result of new information, future events or circumstances or otherwise, except as required by law. Additional information may be available in press releases or other
public announcements and public filings made after the date of this presentation. AVITA Medical's products are Rx only. Please reference the Instructions for Use for more information on indications, contraindications, warnings,
precautions and adverse events. In the United States, RECELL is approved for use in patients suffering acute thermal burns. Use of RECELL in other patient populations is either prohibited by United States law or may be made available
pursuant to a relevant investigational device exemption granted by the FDA (and likewise limited by United States law to investigational use only). Legal Disclaimers
Who is AVITA Medical? Regenerative
medicine company transforming the standard of care for skin restoration with its innovative cellular technology platform, the RECELL System RECELL System includes autologous cell harvesting device that prepares, produces, and delivers
regenerative cellular suspension, Spray-On Skin Cells, within 30 minutes at the point of care. Core advantages: Utilizes small skin sample from patient; significantly less skin relative to conventional skin graft treatment Suspension created
at patient's beside within 30 minutes, further supports healing at the cellular level Multi-cell regenerative therapy in single point-of-care procedure, reducing hospital length of stay In the U.S., RECELL is approved for acute thermal burns.
Use of RECELL in other indications is either (1) limited by United States law to investigational use; or (2) otherwise prohibited. Current U.S. indication: acute thermal burns Pending U.S. indications: soft tissue repair, vitiligo Spray-On Skin
Cells contain cells necessary to regenerate patient's outer layer of natural, healthy skin as well as cells that modulate and catalyze healing process
One Platform. Multiple Indications.
Outpatient Code FDA Submission: December FDA Submission: December Ease of Use Device Launch: July 1 FDA Approval: June In-Office Reimbursement Code: January Launch: January FDA Approval: June Japan: Approval, Reimbursement, Launch BURNS (Approved)
SOFT TISSUE (Expected July 2023) VITILIGO (Expected July 2023) Automated Device Submission: Q3 Pilot Launch: July 1 Automated Device Approval: Q1 U.S. INDICATION 2022 2023 2024 2025
Thermal Burns: U.S. Market Expanded
to Include Small Burns and Outpatient Outpatient Pass Through Code Opens Doors to Small Burns and Expands Market Opportunity Total Annual Burns in the U.S. Severe Burns (as defined as burns > 5% Body Surface Area that may require grafting)
Target: Severe Burns Treated at Burn Centers (Both In and Outpatient) >$600 Million TAM Patient Funnel and Addressable Market ~25K ~80K ~486K PATIENTS PATIENTS PATIENTS
Commercial Revenue Growth:
Third quarter 2022: +30% same quarter prior year Guiding revenue to $33-34 million New RECELL Device: FDA approval and launch of new "Ease of Use" device Japan: PMDA approval of Burns; favorable reimbursement; initial
stocking order in Q3 Soft Tissue Repair: Topline results from pivotal trial: met both co-primary endpoints of statistically superior donor skin sparing and statistically non-inferior healing rates Received FDA Breakthrough Device Designation
Vitiligo: Topline results from pivotal trial: achieved primary effectiveness endpoint of super-superior response rate Received FDA Breakthrough Device Designation Year in Review: Continued Growth and Expansion Quarters referenced in calendar year.
As of January 1, 2022, AVITA Medical is reporting on a calendar year basis. 2022 Recent Accomplishments ($ 000s) Quarter Ended Strong U.S. RECELL Commercial Growth
2023: A Year of Inflection Burns
Soft Tissue Repair Vitiligo $ $ $ Expecting FDA approvals for two indications: Soft Tissue Repair and Vitiligo Soft Tissue Repair: launching in July 2023; 3x market expansion will fuel revenue growth Vitiligo: building case for in-office
reimbursement, focused on MD payment; 3-5x patient population of Burns and Soft Tissue Repair, combined International expansion strategy by end-of-year 2023 Total Addressable Market Soft Tissue Repair and Vitiligo greatly expand U.S. market
RECELL's Perceived Advantages
Vary Depending on Wound Type Extremely Likely Not At All Likely Neutral Fasciotomy & Degloving Necrotizing Skin Infection Flap Donor Site / Abrasion Crush Amputation Traumatic hematoma Laceration Intent to Use Unlike with Burns, most surgeons
would consider RECELL for small wounds
>95K Soft Tissue Repair expands
Burns business to encompass all acute wounds Soft Tissue Repair Opportunity In the U.S., RECELL is approved for acute thermal burns. Use of RECELL in other indications is either (1) limited by United States law to investigational use; or (2)
otherwise prohibited. In the United States, RECELL is not approved for use in pediatrics. Use of RECELL in this case was performed internationally where the indication is approved. 1. 2017 centers for disease control. Open wounds category summary.
https://www.cdc.gov/nchs/data/nhamcs/web_tables/2017_ed_web_tables-508.pdf 2. RECELL eligible calculated using annual unique skin graft patients for trauma wounds per Definitive Healthcare/ .33 ( % of time skin grafts used per market research.
Includes most ideal wounds (degloving, fasciotomy, skin infection, abrasion, crush) plus lacerations and amputations) OPPORTUNITY ESTIMATION Poster: Use of regenerative suspension in the treatment of a complex de-gloving injury. Ian M Smith. Female,