Avita Medical, Inc. · NASDAQ:RCEL
Avita Medical — Shareholder Meeting (December 2021)
61 slides from Avita Medical's shareholder meeting presentation, Dec 23, 2021
Slide 1: Annual Meeting of Stockholders
Annual Meeting of Stockholders DECEMBER 22, 2021 (PST) / DECEMBER 23, 2021 (AEDT) Exhibit 99.2
Slide 2: Call To Order
Mr. Lou Panaccio, Chairman of the Board of Avita Medical, Inc. Call To Order
Slide 3: Brief Company Overview Welcome
Brief Company Overview Welcome
Slide 4: Technical difficulties contact numbers
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?
Slide 5: Introduction of Directors, Officers and Advisers
Introduction of Directors, Officers and Advisers
Slide 6: Board of Directors, Officers, Advisers
Board of Directors Officers Advisers Louis (Lou) Panaccio Chair of the Board of Directors Chair of Today’s Meeting Dr Michael (Mike) Perry Executive Director and Chief Executive Officer Professor Suzanne Crowe Non-executive Director Jeremy Curnock-Cook Non-executive Director Louis (Lou) Drapeau Non-
Slide 7: Introduction of Independent Registered Public Accounting Firm
Grant Thornton, LLP Represented by Mark Bottom Introduction of Independent Registered Public Accounting Firm
Slide 8: Appointment of Inspector of Election
Chairman to appoint Appointment of Inspector of Election
Slide 9: Notice of Meeting Report By Secretary Of Mailing
Notice of Meeting Report By Secretary Of Mailing
Slide 10: Presentation Of List Of Stockholders As Of Record Date
Available upon request Presentation Of List Of Stockholders As Of Record Date
Slide 11: Report Of Quorum
Attendance at this meeting for a quorum Report Of Quorum
Slide 12: Opening of the Polls and Overview of Voting Proposals
Polls for voting on all matters are open Proposals – The Board of Directors recommend a vote FOR all of the nominees listed at Proposal 1, and a vote FOR Proposals 2-15 Opening of the Polls and Overview of Voting Proposals
Slide 13: Election of Directors and Approval of Additional Matters
Election of Directors and Approval of Additional Matters
Slide 14: Proposal 1: Election of Directors
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 Dr. Michael Perry, Director and Chief Executive Officer Jeremy Curnock Cook, Director Louis Drapeau, Director Professor Suzan
Slide 15: Proposal 2: Ratify Grant Thornton
To ratify the appointment of Grant Thornton, LLP as the Company’s independent public accountants for the fiscal year ending June 30, 2022. Proposal 2:
Slide 16: Proposal 3: Bylaws Amendment for Sales Facility
To approve an amendment to the Company’s Amended and Restated Bylaws to provide for the ability of the Company to implement a sales facility with respect to those CDI holders that hold at the relevant time less than a marketable parcel of the Company’s CDIs for the purposes of the ASX Listing Rules
Slide 17: Proposal 4: Ratify Share Issuance
To ratify the issue of 3,214,250 shares of common stock in the capital of the Company with an issue price of US$21.50 per share that were issued pursuant to an underwritten registered public offering that was completed in March 2021 on the terms and conditions set out in this Proxy Statement, pursua
Slide 18: Proposal 5: Director Fee Pool Increase
To approve, for the purposes of ASX Listing Rule 10.17 and the Company’s Amended and Restated Bylaws and for all other purposes, that the maximum aggregate annual cash fee pool from which the non-executive directors of the Company may be paid for their services as members of the board of directors o
Slide 19: Proposal 6: Grant to Mr. Panaccio
To approve the grant of restricted stock units to acquire 4,350 shares of common stock of the Company (which may be represented by CDIs) and the grant of options to acquire 2,550 shares of common stock of the Company (which may be represented by CDIs) to Mr. Louis Panaccio, on the terms and conditio
Slide 20: Proposal 7: Grant to Prof. Crowe
To approve the grant of restricted stock units to acquire 4,350 shares of common stock of the Company (which may be represented by CDIs) and the grant of options to acquire 2,550 shares of common stock of the Company (which may be represented by CDIs) to Professor Suzanne Crowe, on the terms and con
Slide 21: Proposal 8: Grant to Mr. Curnock Cook
To approve the grant of restricted stock units to acquire 4,350 shares of common stock of the Company (which may be represented by CDIs) and the grant of options to acquire 2,550 shares of common stock of the Company (which may be represented by CDIs) to Mr. Jeremy Curnock Cook, on the terms and con
Slide 22: Proposal 9: Grant to Mr. Drapeau
To approve the grant of restricted stock units to acquire 4,350 shares of common stock of the Company (which may be represented by CDIs) and the grant of options to acquire 2,550 shares of common stock of the Company (which may be represented by CDIs) to Mr. Louis Drapeau, on the terms and condition
Slide 23: Proposal 10: Grant to Mr. Corbett
To approve the grant of restricted stock units to acquire 4,350 shares of common stock of the Company (which may be represented by CDIs) and the grant of options to acquire 2,550 shares of common stock of the Company (which may be represented by CDIs) to Mr. James Corbett, on the terms and condition
Slide 24: Proposal 11: Additional Grant to Mr. Corbett
To approve the grant of restricted stock units to acquire 8,675 shares of common stock of the Company (which may be represented by CDIs) and the grant of options to acquire 4,925 shares of common stock of the Company (which may be represented by CDIs) to Mr. James Corbett, on the terms and condition
Slide 25: Proposal 12: Grant to Ms. Reed
To approve the grant of restricted stock units to acquire 4,350 shares of common stock of the Company (which may be represented by CDIs) and the grant of options to acquire 2,550 shares of common stock of the Company (which may be represented by CDIs) to Ms. Jan Stern Reed, on the terms and conditio
Slide 26: Proposal 13: Additional Grant to Ms. Reed
To approve the grant of restricted stock units to acquire 8,675 shares of common stock of the Company (which may be represented by CDIs) and the grant of options to acquire 4,925 shares of common stock of the Company (which may be represented by CDIs) to Ms. Jan Stern Reed, on the terms and conditio
Slide 27: Proposal 14: Grant to CEO Dr. Perry
To approve the grant of restricted stock units to acquire 95,280 shares of common stock of the Company (which may be represented by CDIs) and the grant of options to acquire 55,200 shares of common stock of the Company (which may be represented by CDIs) to the Company’s Chief Executive Officer, Dr.
Slide 28: Proposal 15: Say On Pay
Say On Pay: Advisory vote to approve the compensation of the Company’s named executive officers. Proposal 15:
Slide 29: Proposal 16: Other Business
To transact such other business as may properly come before the meeting or any adjournment or adjournments. No other business has come before the meeting to be considered at this time. Proposal 16:
Slide 30: Closing of Polls
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 o
Slide 31: Adjournment and Question and Answer Period
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 Period
Slide 32: Thank you!
Thank you!
Slide 33: Dr. Michael Perry, December 22, 2021
Company Update Dr. Michael Perry December 22, 2021
Slide 34: Forward-looking statements
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 rega
Slide 35: Key Accomplishments Since Last Shareholder Meeting
Fiscal 2022 RECELL® total net revenue growth of 105% vs prior year Cumulative U.S. commercial sales since September 2018 FDA approval exceeding $46M Soft Tissue Pivotal Trial: 94% Enrolled Vitiligo Pivotal Trial: Enrollment Complete Transitional Pass-Through Payment Application Approved by CMS for R
Slide 36: AVITA Leadership Team
AVITA Leadership Team Dr. Michael S. Perry CEO >30 years experience Affiliations: Michael Holder CFO >30 years experience Affiliations: Donna Shiroma General Counsel >20 years experience Affiliations: Andrew Quick CTO >25 years experience Affiliations: Kathy McGee COO >25 years experience Affiliatio
Slide 37: One Platform. Endless Possibilities.
One Platform. Endless Possibilities. 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. RECELL enables regeneration of healthy skin Patch of healthy skin removed f
Slide 38: Development Pipeline and Growth Potential
Development Pipeline and Growth Potential
Slide 39: Focused Pipeline with Strong Growth Potential
Innovation New Device: Improved Ease of Use New Device: Fully Automated INDICATION DISCOVERY FEASIBILITY PIVOTAL APPROVAL Regenerative Therapeutics – Wounds & Dermatology (Current Platform) Acute Thermal Burns (U.S.) RECELL® Japan Vitiligo (U.S.) Soft Tissue Reconstruction (U.S.) Early-Stage Researc
Slide 40: Market Opportunity of Pipeline Exceeds $22 Billion
EXISTING PLATFORM NEW PLATFORMS: CELL BASED GENE THERAPY > $22 Billion in Combined TOTAL ADDRESSABLE MARKET Market Opportunity of Pipeline Exceeds $22 Billion Skin cells are genetically modified ~$6.8B Opportunity ~$15.8B Opportunity Burns Soft Tissue Vitiligo Epidermolysis Bullosa $ $ $ $ $
Slide 41: Current Platform: Efficacy is Well Demonstrated
Current Platform: Efficacy is Well Demonstrated Highly De-risked Pipeline with >15,000 Patients Treated Globally 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.
Slide 42: Over $46 Million in U.S. RECELL Revenue Since Approval
> $46 Million in U.S. RECELL Revenue Since Approval 78% Burn Sites Activated 87% Burn Surgeons Certified Accomplishments Since Approval Continued Strong Adoption Despite COVID Headwinds *Data is compiled based on information voluntarily provided by our customers and is subject to change. Procedures*
Slide 43: New C-Code Provides Additional Payment in Outpatient Setting
AVITA will ensure broad commercial payer acceptance & coverage before pursuing a full commercial launch This is a Medicare specific code, which we estimate covers ~ 15% of patient lives C1832: Autograft suspension, including cell processing and application, and all system components Code provides ad
Slide 44: New Ease of Use Device Submitted for FDA Approval
New Ease of Use Device Submitted for FDA Approval * Market Research March 2020 HCPs N=15 Only 1 Set of Hands Required in the Sterile Field; Steps Reduced By 1/3rd Reduced number of steps New Device Simplified Process Improved Usability 94% of users of the RECELL System believe it will reduce their w
Slide 45: FDA Approval in Pediatric Full-Thickness & Larger Burns
FDA Approval in Pediatric Full-Thickness & Larger Burns ~25% of all burns occur in children Instructions for Use. RECELL® Autologous Cell Harvesting Device NBR – National Burns Repository * N = 41, “will significantly or somewhat impact RECELL usage” 80% of RECELL Customers Stated that these New Lab
Slide 46: Japan – PMDA Review in the Final Phases
Furue M, Yamazaki S, Jimbow K, Tsuchida T, Amagai M, Tanaka T et al. Prevalence of dermatological disorders in Japan: a nationwide, cross-sectional, seasonal, multi-center, hospital-based study. J Dermatol. 2011 April; 38(4):310-20, Japan Health System Review, 2018. Additional estimates based on dat
Slide 47: Vitiligo: Unmet Need, No FDA-Approved Products
Vitiligo: Unmet Need, No FDA-Approved Products Advances in Vitiligo: An Update on Medical and Surgical Treatments. A. Dillon, et al. J Clin Aesth Derm. 2017. Willingness-to-Pay and Quality of Life in Patients with Vitiligo. Radtke, et al. BJD. 2009. SIGNIFICANT UNMENT NEED Up to 2% of the population
Slide 48: Vitiligo Study Completed in Two Quarters
Blinded, Randomized, Study Evaluating RECELL for Repigmentation of Stable Vitiligo in 23 Patients Vitiligo Study Completed in Two Quarters In the United States, RECELL is not approved for treatment of vitiligo. Patient from a Prior Study at 6 MONTHS RECELL-treated area was 100% re-pigmented RECELL t
Slide 49: Early Completion of Soft Tissue Reconstruction Trial
Early Completion of Soft Tissue Reconstruction Trial Clinical trial demonstrates use of less donor skin without compromising healing outcomes relative to conventional autografting In the U.S., RECELL is approved for acute thermal burns. Use of RECELL in other indications is either (1) limited by Uni
Slide 50: Soft Tissue Synergies with Current Commercial Burn Focus
Soft Tissue Synergies with Current Commercial Burn Focus 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
Slide 51: RECELL in Genetic Skin Defects and Rejuvenation
RECELL in Genetic Skin Defects and Rejuvenation CURRENT PLATFORM FUTURE PLATFORM Treatment using RECELL for harvesting and direct reintroduction of the patient’s own healthy skin cells RECELL as a platform for treatment using the patient’s corrected skin cells Patch of healthy skin removed from pati
Slide 52: Cell Based Gene Therapy Development Activity
Cell Based Gene Therapy Development Activity Study Objectives: Develop a ‘Spray-on’ suspension delivery system of modified cells and establish proof-of-concept Target IND-enablement by establishing preclinical evidence of safety and dosing Proof of Concept FDA Interaction IND-enabling Studies First-
Slide 53: Exploring Cell-Based Gene Therapy for Epidermolysis Bullosa
Exploring Cell-Based Gene Therapy for Epidermolysis Bullosa 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. THE CHALLENGE THE OPPORTUNITY DEBILITATING Skin frag
Slide 54: Exploring Novel RNA-Based Approach for Rejuvenation
Patented RNA technology for delivery of telomerase enzyme to aged cells Demonstrated reversal of aging and return of functionality in cells of progeria patients (human model of accelerated aging) Patented and proprietary Spray-On Skin Cells technology and device (RECELL) Expertise in skin regenerati
Slide 55: Corporate
Corporate
Slide 56: Financial Overview
12 Months Ended June 30 (USD in $000s) 2018 2019 2020 2021 Commercial Sales 929 5,474 14,263 21,483 BARDA Sales - - - 7,749 Total Revenue 929 5,474 14,263 29,232 Gross Profit 383 4,203 11,290 23,283 BARDA Income 7,734 5,921 3,926 2,055 Cash 10,986 20,174 73,639 110,746 $12.45 Share Price1 Financial
Slide 57: Robust Protection Across Patent Families
A Global Total of 56 Granted Patents & 26 Pending Applications Note: AVITA Medical owns granted patents in Austria, Australia, Belgium, Brazil, France, Germany, Hong Kong, Italy, Japan, Netherlands, Portugal, Spain, Sweden, Turkey, United Kingdom and USA. AVITA Medical owns pending patent applicatio
Slide 58: Value Creation Events: Looking Forward
Quarters referenced in calendar year. As of January 1, 2022 Avita Medical will report on a calendar year basis. Value Creation Events: Looking Forward Projected Key Milestones Vitiligo FDA Submission / Vitiligo Commercial launch Last patient enrolled in Soft Tissue Trial / Soft Tissue Commercial Lau
Slide 59: Risk Factors
There are numerous risk factors involved with the Company’s business. Some of these risks can be mitigated by the use of safeguards and appropriate systems and controls, but some are outside the control of the Company and cannot be mitigated. Accordingly, an investment in the Company carries no guar
Slide 60: Indications for Use and Safety Information
INDICATIONS FOR USE: The RECELL® Autologous Cell Harvesting Device is indicated for the treatment of acute thermal burn wounds. The RECELL device is used by an appropriately-licensed healthcare professional at the patient’s point of care to prepare autologous RES® Regenerative Epidermal Suspension f
Slide 61: Revolutionary treatment using a patient's own skin
Revolutionary treatment using a patient’s own skin for life-changing outcomes 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.