AVITA Medical, Inc 8-K, filed Dec 14, 2022
AVITA Medical, Inc. (RCEL)
About this 8-K
AVITA Medical, Inc filed this 8-K on December 14, 2022, reporting on events of December 12, 2022.
Items reported
- Item 5.07: Shareholder vote results
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 5.07. | Submission of Matters to a Vote of Security Holders. |
AVITA Medical, Inc. ( “Company”) held its 2022 Annual Meeting of Stockholders (“Annual Meeting”) virtually on December 12, 2022 (United States) (being December 13, 2022 in Australia). At the Annual Meeting, the total number of shares of common stock eligible to vote as of the record date, October 19, 2022 (Pacific Time), was 25,030,902 and, pursuant to the Company’s Amended and Restated Bylaws, majority shares were required to be present or represented at the Annual Meeting to constitute a quorum. The total number of shares of common stock present or represented at the Annual Meeting was 12,913,899, and a quorum therefore existed.
At the Annual Meeting:
| 1. | Election of Directors. All five directors named in the Company’s Proxy Statement for the Annual Meeting (“Proxy Statement”) were elected to serve on the Company’s Board of Directors with the following vote: |
| Name |
Votes For | Votes Withheld | Non-Votes | |||||||||
| Louis Panaccio (Chair) |
9,299,761 | 1,685,226 | 1,928,912 | |||||||||
| James Corbett (Executive Director and CEO) |
10,360,740 | 624,247 | 1,928,912 | |||||||||
| Jeremy Curnock Cook (Director) |
9,803,894 | 1,181,093 | 1,928,912 | |||||||||
| Professor Suzanne Crowe (Director) |
9,216,541 | 1,768,446 | 1,928,912 | |||||||||
| Jan Stern Reed (Director) |
9,926,444 | 1,058,543 | 1,928,912 | |||||||||
| 2. | Appointment of Independent Auditors. The appointment of Grant Thornton LLP as the Company’s independent public accountants for the fiscal year ending December 31, 2022, was ratified by a vote of (i) 12,430,789 in favor, (ii) 224,743 against, and (iii) 258,367 abstaining. |
| 3. | Amendments to the Company’s Amended and Restated Bylaws: Shareholders did not approve amendments to the Company’s Certificate of Incorporation and Amended and Restated Bylaws to reduce the quorum requirement for stockholder meetings, on the terms and conditions set out in the Proxy Statement, by a vote of (i) 9,587,285 in favor, (ii) 956,344 against, and (iii) 441,358 abstaining. Proposal 3 was not carried as the number of votes required to approve the proposal was not reached. |
| 4. | Issuance of Securities to Mr. Louis Panaccio: Shareholders approved 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, by a vote of (i) 7,637,405 in favor, (ii) 2,735,159 against, and (iii) 612,423 abstaining. |
| 5. | Issuance of Securities to Professor Suzanne Crowe: Shareholders approved 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, by a vote of (i) 7,656,800 in favor, (ii) 2,666,551 against, and (iii) 661,636 abstaining. |
| 6. | Issuance of Securities to Mr. Jeremy Curnock Cook: Shareholders approved 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, by a vote of (i) 7,612,792 in favor, (ii) 2,745,543 against, and (iii) 626,652 abstaining. |
| 7. | Issuance of Securities to Ms. Jan Stern Reed: Shareholders approved 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, by a vote of (i) 7,657,643 in favor, (ii) 2,674,563 against, and (iii) 652,781 abstaining. |
| 8. | Issuance of Securities to Mr. James Corbett: Shareholders approved 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, by a vote of (i) 8,476,617 in favor, (ii) 1,869,887 against, and (iii) 638,483 abstaining. |
| 9. | Advisory Vote to Approve Compensation of Named Executive Officers: Shareholders voted in favor of the non-binding advisory vote to approve the compensation of the Company’s named executive officers, by a vote of (i) 7,832,181 in favor, (ii) 2,381,954 against, and (iii) 770,852 abstaining. |
| Item 7.01 | Reg Fd Disclosure; Item 8.01 Other Events |
At the Annual Meeting, the Company presented a slide deck containing certain information attached hereto as Exhibit 99.1. Following the Annual Meeting, the Company issued a press release announcing the voting results with respect to each of the proposals presented to stockholders at the Annual Meeting. A copy of the Company’s press release is included as Exhibit 99.2.
The information under Item 5.07, Item 7.01, Item 8.01, and in Item 9.01 below is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 and shall not be deemed incorporated by reference into any filing made under the Securities Act of 1933, except as expressly set forth by specific reference in such filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit |
Description of Exhibit | |
| 99.1 | Annual Meeting Presentation. | |
| 99.2 | AVITA Medical Announces Results of 2022 Annual Meeting of Stockholders. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
SIGNATURE
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 hereunto duly authorized.
Date: December 14, 2022
| AVITA MEDICAL, INC. | ||
| By: | /s/ Donna Shiroma | |
| Name: | Donna Shiroma | |
| Title: | General Counsel | |
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 Present Today
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 Of Mailing
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 Period
Conclusion of Annual Meeting of Stockholders
Thank you!
Company Update
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 opportunity
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, pregnant 28-year-old who suffered from a de-gloving injury POST DEBRIDEMENT OF INJURY 6 MONTH POST-RECELL TREATMENT >4.5M >110K Wounds With a High Perceived RECELL Benefit2 Total Open Wound ER Visits in the U.S.1 RECELL Eligible Soft Tissue Wounds2
Overlap of Burns and Soft Tissue Repair RECELL eligible whenever a skin graft may be required Sales Team Will Target a Total of >1,000 Centers BURNS MARKET ~150 Burn Centers SOFT TISSUE MARKET Level 1 & 2 Trauma Centers 75% of Targeted Procedures >300 Surgeons 78% of Targeted Procedures >1,000 Surgeons Interest in Use: FT or DPT Burns >5% TBSA Interest in Use: Degloving, Abrasion, Fasciotomy & Necrotizing Fasciitis Existing Burns Market Broadened by Soft Tissue Repair
Synergies of Burns and Soft Tissue Repair Synergies enhance commercial launch of Soft Tissue Repair in July 2023 50% of Burns centers co-located with level 1 and level 2 trauma centers 25% of Burns are treated in level 1 and level 2 trauma centers, which are not co-located with burn centers; thus not covered by current sales team Soft Tissue Repair in-patient reimbursement: same code as Burns; effective immediately upon FDA approval Soft Tissue Repair out-patient transitional pass-through code (TPTC): same code as Burns; effective immediately upon FDA approval In April 2023, existing sales force to start Value Analysis Committee discussions in level 1 and level 2 trauma centers Sales force expansion will occur during Q2 2023 in anticipation of July 1 launch AVITA Medical growth over the next three to five years fueled by Soft Tissue Repair and Burns
Vitiligo Indication on Track for FDA Submission Primary Endpoint Proportion of study sites achieving ≥80% re-pigmentation for RECELL-treated sites vs Control at Week 24 In the United States, RECELL is not approved for treatment of vitiligo. A B Control NB-UVB alone Treatment Laser ablation + (1:20) + NB-UVB FDA submission in December 2022 with expected approval in June 2023 Study achieved its primary effectiveness endpoint of super-superiority Super-superiority was established for the primary endpoint (p<0.025 ) Effectiveness Data Preliminary review of adverse events shows consistency with prior RECELL experience Safety Data Within-subject comparison
Vitiligo Opportunity *NB-UVB protocol per Vitiligo Working Group recommendations JAAD 2017. In the United States, RECELL is not approved for treatment of vitiligo. 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. 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. OPPORTUNITY ESTIMATION Targeting <1,000 procedural dermatologists and plastic surgeons who, along with patients, have extremely low satisfaction with existing products RECELL treated Negative Control First-in-class re-pigmentation transplantation of melanocytes Komen L, Vrijman C, Tjin EP, Krebbers G, de Rie MA, Luiten RM, van der Veen JW, Wolkerstorfer A. Autologous cell suspension transplantation using a cell extraction device in segmental vitiligo and piebaldism patients: a randomized controlled pilot study. Journal of the American Academy of Dermatology. 2015 Jul;73(1):170-2. Prevalence of Adult Vitiligo in the U.S. ~2.2M Stable Vitiligo Patients ~1.3M Undiagnosed Patients 370k Diagnosed Patients 555k Surgically Eligible ~925k Seeking Treatment 438k RECELL treatment against "control" unmatched at six months Patient from a prior study at six-months RECELL-treated area was 100% re-pigmented
Vitiligo Strategy Expect FDA approval in July 2023 Proposed RECELL indication represents first-in-class re-pigmentation transplantation of melanocytes Plans for 2023 – 2024: Build podium presence MD initiated research to refine patient selection Focus on in-office reimbursement Vitiligo opens significant market application of RECELL Vitiligo Market Five Times the Size of Combined Burns and Soft Tissue Repair
Growth Enabler: Automated Device for All Indications New RECELL Automated Device in development for Soft Tissue Repair / Burns (automated device for Vitiligo to follow): FDA Submission expected in Q3 2023 FDA Approval expected in Q1 2024 Protected by issued patents in the U.S. and certain other countries for automated device, which provides a further barrier to entry for potential competitors KEY UPDATES
Summary Burns Core Burn centers will continue to penetrate, adopt and grow Burns utilization will expand, accessing 25% of market not currently called on by AVITA Medical Burns sales team Strong healthcare economics drive in-patient adoption; TPTC broadens coverage Soft Tissue Repair Represents 3x expansion of market opportunity in level 1 and level 2 trauma centers Reimbursement starts DAY 1 using same codes and reimbursement as Burns Vitiligo Reimbursement expected January 2025 Represents 5x patient population of Burns and Soft Tissue Repair, combined Opens significant market application of RECELL Outlook over next 3 to 5 years in U.S. AVITA Medical growth driven by Burns and Soft Tissue Repair Vitiligo comes to market adoption with in-office reimbursement in 2025 International expansion plans by end-of-year 2023 Near-term growth driven by Burns and Soft Tissue Repair market expansion
Contact Information Please contact investor@avitamedical.com for all questions or concerns.
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.
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 guarantee with respect to the payment of dividends, return of capital or price at which securities will trade. The following is a summary of the more material matters to be considered. However, this summary is not exhaustive. Potential investor should consult their professional advisors before deciding whether to invest. Technological Change: Technological change presents the Company with significant opportunities for growth. However, the risk remains that any competitor may introduce new technology enabling it to gain a significant competitive advantage over the Company. Reliance on key personnel: The Company's success depends to a significant extent upon its key management personnel, as well as other management and technical personnel including sub-contractors. The loss of the services of any such personnel could have an adverse effect on the Company. Competition: The Company competes with other companies in the United States as well as in Australia and internationally. Some of these companies have greater financial and other resources than the Company and, as a result, may be in a better position to compete for future business opportunities. There can be no assurance that the Company can compete effectively with these companies. Patent Protection: The patent protection that the Company may obtain varies from product to product and country to country and may not be sufficient, including to maintain product exclusivity. Patent rights are also limited in time and do not always provide effective protection for products and services: competitors may successfully avoid patents through design innovation, the Company may not hold sufficient evidence of infringement to bring suit, or the infringement claim may not result in a decision that the rights are valid, enforceable or infringed. Legislation or regulatory actions subsequent to the filing date of a patent application may affect what an applicant is entitled to claim in a pending application and may also affect whether a granted patent can be enforced in certain circumstances. Laws relating to biotechnology remain the subject of ongoing political controversy in some countries. The risk of changed laws affecting patent rights is generally considered greater for the biotechnology field than in other longer established fields. Change in government policy and legislation: Any material adverse changes in relevant government policies or legislation of Australia / United States may affect the viability and profitability of the Company, and consequent returns to investors. The activities of the Company are subject to various federal, state and local laws governing prospecting, development, production, taxes, labor standards and occupational health and safety, and other matters. Clinical Studies to Support Any Regulatory Applications for Additional Commercial Applications: The Company cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all. As a result, we may not achieve the expected clinical milestones necessary for approval by the FDA, or other regulators, for the use of RECELL® System for additional applications in the United States or other countries. A failure or delay in a clinical study or regulatory application can occur at any stage. Delays can be costly and could negatively affect our ability to complete clinical trials for our product candidates. If we are not able to successfully complete clinical trials, we will not be able to obtain regulatory approval for the use of our product for additional applications, all of which could have a material adverse effect on our business, financial condition and results of operations. Risk Factors and Disclosures
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 for direct application to acute partial-thickness thermal burn wounds in patients 18 years of age and older or application in combination with meshed autografting for acute full-thickness thermal burn wounds in pediatric and adult patients. CONTRAINDICATIONS: RECELL is contraindicated for: the treatment of wounds clinically diagnosed as infected or with necrotic tissue, the treatment of patients with a known hypersensitivity to trypsin or compound sodium lactate (Hartmann’s) solution, patients having a known hypersensitivity to anesthetics, adrenaline/epinephrine, povidone-iodine, or chlorhexidine solutions. WARNINGS: Autologous use only. Wound beds treated with a cytotoxic agent (e.g., silver sulfadiazine) should be rinsed prior to application of the cell suspension. RECELL is provided sterile and is intended for single-use. Do not use if packaging is damaged or expired. Choose a donor site with no evidence of cellulitis or infection and process skin immediately. A skin sample should require between 15 and 30 minutes contact with Enzyme. Contact in excess of 60 minutes is not recommended. RECELL Enzyme is animal derived and freedom from infectious agents cannot be guaranteed. PRECAUTIONS: RECELL is not intended for use without meshed autograft for treatment of full-thickness burn wounds. The safety and effectiveness of RECELL without meshed autograft have not been established for treatment of partial-thickness burn wounds: on the hands and articulating joints, >320 cm2, in patients with wounds totaling >20% total body surface area (TBSA). The safety and effectiveness of RECELL with autografting have not been established for treatment of full-thickness burn wounds: on the hands and articulated joints, and in patients younger than 28 days of age (neonates). SPECIAL PATIENT POPULATIONS: The safety and effectiveness of RECELL have not been established for treatment of acute thermal partial-thickness burn wounds in pediatric patients younger than 18 years of age. Important Safety Information
This concludes the Company Update. Thank you for your attendance.
Exhibit 99.2
AVITA Medical Announces Results of 2022 Annual Meeting of Stockholders
VALENCIA, Calif. and MELBOURNE, Australia, December 12, 2022 (United States) / December 13, 2022 (Australia) (GLOBE NEWSWIRE) — AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (Company), a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, today announced the results of its 2022 Annual Meeting of Stockholders, which was held virtually on December 12, 2022 (United States) (being December 13, 2022 in Australia).
Election of Directors: All five directors named in the Company’s proxy statement dated October 19, 2022 (Proxy Statement) were elected or re-elected, as applicable, to serve on the Company’s Board of Directors: Louis Panaccio, Chair; James Corbett, Executive Director and CEO; Professor Suzanne Crowe, Director; Jeremy Curnock Cook, Director; and Jan Stern Reed, Director.
Appointment of Independent Auditors: Stockholders approved the ratification of Grant Thornton LLP as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2022, as described in the Proxy Statement.
Amendments to the Company’s Amended and Restated Bylaws: Stockholders did not approve the proposal to amend the Company’s Amended and Restated Bylaws to reduce the quorum requirement for stockholder meetings, as the number of votes required to approve the proposal was not reached.
Issuance of Securities to Mr. Louis Panaccio: Stockholders approved 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 the Proxy Statement, pursuant to and for the purposes of ASX Listing Rule 10.11.
Issuance of Securities to Professor Suzanne Crowe: Stockholders approved 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 the Proxy Statement, pursuant to and for the purposes of ASX Listing Rule 10.11.
Issuance of Securities to Mr. Jeremy Curnock Cook: Stockholders approved 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 the Proxy Statement, pursuant to and for the purposes of ASX Listing Rule 10.11.
Issuance of Securities to Ms. Jan Stern Reed: Stockholders approved 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 the Proxy Statement, pursuant to and for the purposes of ASX Listing Rule 10.11.
Issuance of Securities to Mr. James Corbett: Stockholders approved 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 the Proxy Statement, pursuant to and for the purposes of ASX Listing Rule 10.11.
Advisory Vote to Approve Compensation of Named Executive Officers: Stockholders voted in favor of the non-binding advisory vote to approve the compensation of the Company’s named executive officers.
The final votes have been reported in a Form 8-K that was filed with the Securities and Exchange Commission earlier today. The filing can be found on the Company’s website at https://ir.avitamedical.com/financials/sec-filings.
The voting results of the Annual Meeting of Stockholders for the purposes of ASX Listing Rule 3.13.2 are attached to this announcement.
Authorized for release by the Chief Executive Officer of AVITA Medical, Inc.
# # #
ABOUT AVITA MEDICAL, INC.
AVITA Medical® is a regenerative medicine company leading the development and commercialization of devices and autologous cellular therapies for skin restoration. The RECELL® System technology platform, approved by the FDA for the treatment of acute thermal burns in both adults and children, harnesses the regenerative properties of a patient’s own skin to create Spray-On Skin™ cells. Delivered at the point-of- care, RECELL enables improved clinical outcomes and validated cost savings. RECELL is the catalyst of a new treatment paradigm and AVITA Medical is leveraging its proven and differentiated capabilities to develop first-in-class cellular therapies for multiple indications, including soft tissue repair and repigmentation of stable vitiligo lesions.
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 approved for acute partial-thickness thermal burn wounds in patients 18 years of age and older or application in combination with meshed autografting for acute full-thickness thermal burn wounds in pediatric and adult patients. In February 2022, the FDA reviewed and approved the PMA supplement for RECELL Autologous Cell Harvesting Device, an enhanced RECELL System aimed at providing clinicians a more efficient user experience and simplified workflow.
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 15,000 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 approved under the RECELL System brand to promote skin healing in a wide range of applications including burns, soft tissue repair, vitiligo, and aesthetics. The RECELL System is TGA-registered in Australia, received CE-mark approval in Europe and has PMDA approval in Japan.
To learn more, visit www.avitamedical.com.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This press release 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 press release 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 press release 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 forward-looking statements contained in this press release. 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 press release speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.
This press release was authorized by the review committee of AVITA Medical, Inc.
FOR FURTHER INFORMATION:
| Investors & Media |
| AVITA Medical, Inc. |
| Jessica Ekeberg |
|
Phone +1-661-904-9269 investor@avitamedical.com media@avitamedical.com
|
PR 2022AGM 12122022
# # #
AVITA Medical, Inc.
Annual Meeting of Shareholders
December 12, 2022 (United States) / December 13, 2022 (Australia)
Voting Results
The following information is provided for the purposes of ASX Listing Rule 3.13.2.
| Resolution details |
Instructions given to validly appointed proxies (as at proxy close) |
Number of votes cast on the poll | Resolution result | |||||||||||||||||||||||||||
| Resolution |
For | Against | Proxy’s discretion |
Abstain | For | Against | Abstain* | Carried / not carried | ||||||||||||||||||||||
| Resolution 1: Election of Directors to serve a one-year term |
9,299,761 | 0 | 0 | 1.685,226 | 9,299,761 | 0 | 1,685,226 | Carried | ||||||||||||||||||||||
| Louis Panaccio, Non- Executive Chairman of the Board of Directors |
84.66 | % | 0 | % | 0 | % | 15.34 | % | 84.66 | % | 0 | % | 15.34 | % | ||||||||||||||||
| Resolution 1: Election of Directors to serve a one-year term |
10,360,740 | 0 | 0 | 624,247 | 10,360,740 | 0 | 624,247 | Carried | ||||||||||||||||||||||
| James Corbett, Executive Director and Chief Executive Officer |
94.32 | % | 0 | % | 0 | % | 5.68 | % | 94.32 | % | 0 | % | 5.68 | % | ||||||||||||||||
| Resolution 1: Election of Directors to serve a one-year term |
9,803,894 | 0 | 0 | 1,181,093 | 9,855,810 | 0 | 1,181,093 | Carried | ||||||||||||||||||||||
| Jeremy Curnock Cook, Non-Executive Director |
89.25 | % | 0 | % | 0 | % | 10.75 | % | 87.45 | % | 0 | % | 10.75 | % | ||||||||||||||||
| Resolution 1: Election of Directors to serve a one-year term |
9,216,541 | 0 | 0 | 1,768,446 | 9,216,541 | 0 | 1,768,446 | Carried | ||||||||||||||||||||||
| Professor Suzanne Crowe, Non-Executive Director |
83.90 | % | 0 | % | 0 | % | 16.10 | % | 83.90 | % | 0 | % | 16.10 | % | ||||||||||||||||
| Resolution 1: Election of Directors to serve a one-year term
Jan Stern Reed, Non-Executive Director |
|
9,926,444
90.36 |
% |
|
0
0 |
% |
|
0
0 |
% |
|
1,058,543
9.64 |
% |
|
9,926,444
90.36 |
% |
|
0
0 |
% |
|
1,058,543
9.64 |
% |
Carried | ||||||||
| Resolution 2: To ratify the appointment of Grant Thornton LLP as the Company’s independent public accountants for the fiscal year ending December 31, 2022. |
|
12,430,789
96.26 |
% |
|
224,743
1.74 |
% |
|
0
0 |
% |
|
258,367
2.00 |
% |
|
12,430,789
96.26 |
% |
|
224,743
1.74 |
% |
|
258,367
2.00 |
% |
Carried | ||||||||
| Resolution 3: To approve amendments to the Company’s Amended and Restated Bylaws to reduce the quorum requirement for stockholder meetings. |
|
9,587,285
87.27 |
% |
|
956,344
8.71 |
% |
|
0
0 |
% |
|
441,358
4.02 |
% |
|
9,587,285
87.27 |
% |
|
956,344
8.71 |
% |
|
441,358
4.02 |
% |
Not Carried** | ||||||||
| Resolution 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 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. |
|
7,637,405
69.52 |
% |
|
2,735,159
24.90 |
% |
|
0
0 |
% |
|
612,423
5.58 |
% |
|
7,637,405
69.52 |
% |
|
2,735,159
24.90 |
% |
|
612,423
5.58 |
% |
Carried | ||||||||||
| Resolution 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 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. |
|
7,656,800
69.71 |
% |
|
2,666,551
24.27 |
% |
|
0
0 |
% |
|
661,636
6.02 |
% |
|
7,656,800
69.71 |
% |
|
2,666,551
24.27 |
% |
|
661,636
6.02 |
% |
Carried | ||||||||||
| Resolution 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 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. |
|
7,612,792
69.31 |
% |
|
2,745,543
24.99 |
% |
|
0
0 |
% |
|
626,652
5.70 |
% |
|
7,612,792
69.31 |
% |
|
2,745,543
24.99 |
% |
|
626,652
5.70 |
% |
Carried | ||||||||||
| Resolution 7: 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. |
|
7,657,643
69.71 |
% |
|
2,674,563
24.35 |
% |
|
0
0 |
% |
|
652,781
5.94 |
% |
|
7,657,643
69.71 |
% |
|
2,674,563
24.35 |
% |
|
652,781
5.94 |
% |
Carried | ||||||||||
| Resolution 8: 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. |
|
8,476,617
77.17 |
% |
|
1,869,887
17.02 |
% |
|
0
0 |
% |
|
638,483
5.81 |
% |
|
8,476,617
77.17 |
% |
|
1,869,887
17.02 |
% |
|
638,483
5.81 |
% |
Carried | ||||||||||
| Resolution 9: Advisory vote to approve the compensation of the Company’s named executive officers. |
|
7,832,181
71.30 |
% |
|
2,381,954
21.68 |
% |
|
0
0 |
% |
|
770,852
7.02 |
% |
|
7,832,181
71.30 |
% |
|
2,381,954
21.68 |
% |
|
770,852
7.02 |
% |
Carried |
| * | Votes relating to a person who abstained on Resolution 1 or any of Resolutions 4 - 8 (as applicable) were not counted in determining whether or not the required majority of votes were cast for or against that Resolution. Votes relating to a person who abstained on Resolutions 2, 3 or 9 (as applicable) were counted as votes “AGAINST” that Resolution in determining whether or not the required majority of votes were cast for or against that Resolution. |
| ** | Resolution 3 was not carried as the number of votes required to approve the proposal was not reached. |