VALENCIA, Calif., Jan. 10, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ:RCEL, ASX: AVH))) (the "Company"), a commercial-stage regenerative medicine company focused on first-in-class devices and autologous cellular therapies for skin restoration, today announced preliminary unaudited financial highlights for the fourth quarter and full-year 2023, provided financial guidance for the first quarter and full-year 2024, and announced completion of patient enrollment in its post-market study, TONE. Prelimi ...

AVITA Medical, Inc. (NASDAQ:RCEL) Q3 2023 Results Conference Call November 9, 2023 4:30 PM ET Company Participants Jessica Ekeberg - Director of Investor Relations Jim Corbett - Chief Executive Officer David O’Toole - Chief Financial Officer Conference Call Participants Joshua Jennings - Cowen Brooks O'Neil - Lake Street Capital Markets John Hester - Bell Potter Ross Osborne - Cantor Fitzgerald Madeline Williams - Wilsons Operator Good day, and thank you for standing by. Welcome to the AVITA Medical Third Q ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39059 AVITA MEDICAL, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or orga ...

Financial Data and Key Metrics Changes - The company reported commercial revenues of $11.7 million for Q2 2023, representing a 42% increase compared to $8.2 million in the same period in 2022, and at the top end of the guidance range of $10.7 million to $11.7 million [26][60] - The gross profit margin was 81%, down from 83% in the same period in 2022, primarily due to decreased product production in one month of the quarter [39] - The net loss for the quarter was $10.4 million, or a loss of $0.41 per share, compared to a net loss of $6.3 million, or a loss of $0.25 per share in the same period in 2022 [63] Business Line Data and Key Metrics Changes - The increase in commercial revenue was largely driven by broader surgeon usage and deeper penetration, particularly within smaller burn procedures [52] - The company achieved two landmark FDA approvals and a pivotal FDA submission, which are critical for advancing its platform and unlocking growth potential [25] Market Data and Key Metrics Changes - The expansion into trauma centers allows the commercial team to capture a larger portion of the burn market, with an initial target market of approximately 127,000 eligible soft tissue repair procedures and 35,000 eligible burn procedures, representing a total addressable market (TAM) of over $1.2 billion [43] - Japan represents a majority of the foreign revenue line item, with over 90% of international revenue coming from this market [102] Company Strategy and Development Direction - The company is expanding its focus from burn centers to include hospitals, trauma centers, and outpatient settings, with plans to build out its portfolio and explore external business development opportunities [20] - The company is increasing its 2023 annual revenue guidance from $49 million to $51 million, now expecting a range of $51 million to $53 million, reflecting a 53% growth over 2022 at the midpoint of guidance [37][64] Management's Comments on Operating Environment and Future Outlook - Management expressed bullishness about the remainder of the year and 2024, citing early momentum and preparation for new approvals [13] - The company plans to provide 2024 guidance in February 2024, indicating a solid balance sheet and ongoing development of its 2024 plan [51][77] Other Important Information - The company initiated the expansion of its commercial organization, more than doubling its team from 30 to 70, which will result in peak operating expenses as a percentage of revenue in Q3 2023 [47] - The RECELL GO product is expected to significantly ease the burden of training required for physicians and operating room staff, leading to increased adoption across indications [80] Q&A Session Summary Question: Can you provide insight on the broader label secured for soft-tissue data and the potential rethinking of the commercial organization structure? - Management indicated that there are numerous applications under full-thickness skin defects that create a much bigger opportunity, and they plan to assess these before rushing into new initiatives [56] Question: What is the expected timeline for new sales reps to reach productivity levels? - It was noted that new sales reps typically take three to six months to reach cost coverage, with five resale kits per month needed to break even [101] Question: How does the company view margins longer term with the introduction of RECELL GO? - Management expects margins to increase as sales volume grows, potentially approaching 90% margins if sales align with expectations [106] Question: What specific cases are doctors most comfortable with regarding the new indication for full-thickness skin defects? - Management mentioned that cases like degloving and necrotizing fasciitis are being captured quickly, indicating a positive early adoption trend [107]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39059 AVITA MEDICAL, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organizat ...

AVITA Medical, Inc. (NASDAQ:RCEL) Q1 2023 Results Conference Call May 11, 2023 4:30 PM ET Company Participants Jessica Ekeberg - Investor Relations James Corbett - Chief Executive Officer Sean Ekins - Acting Chief Financial Officer Conference Call Participants Joshua Jennings - TD Cowen Phillip Dantoin - Piper Sandler Ryan Zimmerman - BTIG Operator Good day and thank you for standing by. Welcome to the AVITA Medical Inc. First Quarter 2023 Earnings Conference Call. At this time all participants are in a lis ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39059 AVITA MEDICAL, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organiza ...

AVITA Medical, Inc. (NASDAQ:RCEL) Q4 2022 Earnings Conference Call February 23, 2023 4:30 PM ET Company Participants Caroline Corner - Managing Director, Investor Relations Jim Corbett - Chief Executive Officer Sean Ekins - Acting Chief Financial Officer Conference Call Participants Joshua Jennings - Cowen Phillip Dantoin - Piper Brooks O'Neil - Lake Street Capital Markets Lyanne Harrison - Bank of America Operator Good day and thank you for standing by. Welcome to AVITA Medical Fourth Quarter 2022 Earnings ...

Part I [Business](index=4&type=section&id=Item%201.%20BUSINESS) AVITA Medical is a regenerative medicine company focused on skin restoration through its proprietary RECELL® System - AVITA Medical is a regenerative medicine company commercializing the RECELL® System, a technology that creates an autologous skin cell suspension (Spray-On Skin™ Cells) to regenerate skin[17](index=17&type=chunk) - The company's core strategy includes increasing penetration in the U.S. burns market, commercializing RECELL for soft tissue repair and vitiligo following anticipated FDA approvals, and expanding internationally, particularly in Japan[30](index=30&type=chunk) - In December 2022, the company submitted a Premarket Approval (PMA) supplement application to the FDA for the use of RECELL in soft tissue repair and a separate PMA application for its use in treating vitiligo[51](index=51&type=chunk)[59](index=59&type=chunk) RECELL System Clinical Benefits | Indication | Key Benefit | | :--- | :--- | | **2nd-Degree Burns** | Used **97.5% less donor skin** compared to standard care | | **3rd-Degree Burns** | Used **32% less donor skin** when combined with autograft | | **Pediatric Cases** | **56% fewer mean surgical procedures** compared to NBR | Estimated U.S. Addressable Markets | Indication | Estimated Annual Market Size | | :--- | :--- | | **Burns** | ~35,000 patients annually | | **Soft Tissue Repair** | ~$1 billion | | **Vitiligo** | ~$5 billion | - The company has a contract with BARDA valued at approximately **$53.3 million** to support the development of the RECELL System and for emergency preparedness[86](index=86&type=chunk)[87](index=87&type=chunk) - The company's core U.S. patent (No. 9,029,140) covering the RECELL System is in force until February 6, 2024, with a Patent Term Extension (PTE) application filed to extend it to **April 9, 2024**[76](index=76&type=chunk)[78](index=78&type=chunk) [Risk Factors](index=16&type=section&id=Item%201A.%20RISK%20FACTORS) The company faces significant financial, operational, and intellectual property risks, including a history of losses and dependency on regulatory approvals - The company has a history of significant losses, reporting a **net loss of $26.7 million** for the year ended December 31, 2022, and has an **accumulated deficit of $262.6 million**[108](index=108&type=chunk) - Future growth is **highly dependent on obtaining additional FDA approvals** for the RECELL System in new indications, such as soft tissue repair and vitiligo[110](index=110&type=chunk) - The company faces manufacturing risks at its Ventura, California facility and **relies on single-source suppliers** for some components, making it vulnerable to supply chain disruptions[127](index=127&type=chunk)[131](index=131&type=chunk)[132](index=132&type=chunk) - A core U.S. patent for the RECELL System will **expire in February 2024**, which could allow competitors to introduce similar products and impair the company's competitive position[150](index=150&type=chunk) - The business is subject to risks from **unfavorable pricing regulations and third-party reimbursement policies** from government or private insurers[121](index=121&type=chunk)[162](index=162&type=chunk) - Macroeconomic risks, including the ongoing effects of the COVID-19 pandemic, supply chain disruptions, inflation, and potential economic recession, could adversely affect customer demand and operating results[165](index=165&type=chunk)[171](index=171&type=chunk) [Unresolved Staff Comments](index=29&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - There are no unresolved staff comments[191](index=191&type=chunk) [Properties](index=29&type=section&id=Item%202.%20PROPERTIES) AVITA Medical leases its corporate office and production plant in California and does not own any real property - The company's principal corporate office is a **17,500 sq. ft.** leased facility in Valencia, California, with the lease expiring on October 31, 2026[191](index=191&type=chunk) - The production plant is a **27,480 sq. ft.** leased facility in Ventura, California, with a lease through September 30, 2024[191](index=191&type=chunk) [Legal Proceedings](index=29&type=section&id=Item%203.%20LEGAL%20PROCEEDINGS) The company is not currently a party to any material pending legal proceedings - As of the report date, the company is not a party to any material pending legal proceedings[192](index=192&type=chunk) [Mine Safety Disclosures](index=29&type=section&id=Item%204.%20MINE%20SAFETY%20DISCLOSURES) This section is not applicable to the company's operations - Not applicable[193](index=193&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=30&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock and CDIs trade on Nasdaq and ASX respectively, and it does not anticipate paying cash dividends - The company's common stock is listed on the Nasdaq Capital Market (ticker: **RCEL**) and its CDIs are quoted on the ASX (ticker: **AVH**)[196](index=196&type=chunk) - As of January 31, 2023, the company had approximately **23,190 unique stockholders** of record[197](index=197&type=chunk) - The company has **never paid cash dividends** and does not intend to in the foreseeable future, planning to retain earnings for business use[198](index=198&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Total revenue grew 4% to $34.4 million in 2022, driven by commercial sales, while the net loss widened slightly due to increased operating expenses Results of Operations (Year-Ended Dec 31) | Metric | 2022 | 2021 | % Change | | :--- | :--- | :--- | :--- | | **Revenues** | $34.4M | $33.0M | 4% | | Commercial Revenues | $34.0M | $25.1M | 36% | | **Gross Profit** | $28.4M | $26.9M | 5% | | Gross Margin | 82% | 82% | 0% | | **Total Operating Expenses** | $59.1M | $53.6M | 10% | | **Operating Loss** | ($27.5M) | ($25.1M) | (10)% | | **Net Loss** | ($26.7M) | ($25.1M) | (6)% | - The **35% increase in sales and marketing expenses** in 2022 was driven by higher selling costs, pre-commercialization activities for planned new launches, and an increase in field personnel[212](index=212&type=chunk) - Research and development expenses **decreased by 12%** in 2022 as pivotal trials moved into less costly follow-up phases[215](index=215&type=chunk) Liquidity Position as of Dec 31, 2022 | Item | Amount (in millions) | | :--- | :--- | | Cash and cash equivalents | $18.2 | | Marketable securities | $68.1 | - Net cash used in operating activities was **$19.1 million** for the year ended December 31, 2022, an increase from $18.0 million in the prior year[233](index=233&type=chunk) - Critical accounting policies include revenue recognition under ASC 606, accounting for government grants from BARDA, and share-based compensation[243](index=243&type=chunk)[254](index=254&type=chunk)[257](index=257&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, AVITA Medical is not required to provide this information - The company is not required to provide this information as it qualifies as a smaller reporting company[265](index=265&type=chunk) [Financial Statements and Supplementary Data](index=39&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section contains the company's audited consolidated financial statements for fiscal year 2022 and prior periods - The financial statements were audited by Grant Thornton LLP, which issued an **unqualified opinion**[396](index=396&type=chunk) Key Financial Statement Data (as of Dec 31, 2022) | Metric | Amount (in thousands) | | :--- | :--- | | **Balance Sheet** | | | Total Assets | $98,264 | | Total Liabilities | $12,967 | | Total Shareholders' Equity | $84,740 | | **Statement of Operations (FY 2022)** | | | Revenues | $34,421 | | Net Loss | ($26,665) | | **Statement of Cash Flows (FY 2022)** | | | Net Cash Used in Operations | ($19,090) | [Controls and Procedures](index=39&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls, procedures, and internal controls over financial reporting were effective as of year-end 2022 - Management concluded that the company's disclosure controls and procedures were **effective** as of December 31, 2022[268](index=268&type=chunk) - Management concluded that the company's internal control over financial reporting was **effective** as of December 31, 2022, based on the COSO framework (2013)[269](index=269&type=chunk) - **No material changes** were made to the company's internal control over financial reporting during the three months ended December 31, 2022[271](index=271&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=41&type=section&id=Item%2010.%20DIRECTORS%2C%20EXECUTIVE%20OFFICERS%20AND%20CORPORATE%20GOVERNANCE) The company details its board of directors and executive team, committee structures, and compliance with gender diversity targets Board of Directors | Name | Position | | :--- | :--- | | Lou Panaccio | Chairman of the Board | | Jeremy Curnock Cook | Non-Executive Director | | Professor Suzanne Crowe | Non-Executive Director | | Jan Stern Reed | Non-Executive Director | | James Corbett | Executive Director and CEO | Executive Officers | Name | Position | | :--- | :--- | | James Corbett | Chief Executive Officer | | Sean Ekins | Interim Chief Financial Officer | | Erin Liberto | Chief Commercial Officer | | Andrew Quick | Chief Technology Officer | | Donna Shiroma | General Counsel | - The company has achieved its gender diversity target, with the Board of Directors being **40% female** and 60% male[293](index=293&type=chunk) - The Board has three standing committees: Audit, Compensation, and Nominating and Corporate Governance, each composed of independent directors[304](index=304&type=chunk)[305](index=305&type=chunk) [Executive Compensation](index=47&type=section&id=Item%2011.%20EXECUTIVE%20COMPENSATION) Executive compensation comprises base salary, performance bonuses, and long-term equity, with CEO James Corbett's 2022 total compensation at $1.5 million 2022 Summary Compensation for Key NEOs | Name and Position | Salary ($) | Bonus ($) | Stock Awards ($) | Option Awards ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | | **James Corbett**, CEO | 156,992 | 100,726 | - | 1,232,747 | 1,495,584 | | **Michael Holder**, CFO | 430,128 | 184,900 | 178,672 | 82,524 | 925,212 | | **Erin Liberto**, CCO | 421,999 | 180,812 | 178,672 | 82,524 | 906,293 | | **Michael Perry**, Former CEO | 461,512 | - | - | - | 804,498 | - Employment contracts for executive officers provide for severance payments, typically **9-12 months of base salary** and a pro-rated target bonus, upon involuntary termination[326](index=326&type=chunk)[335](index=335&type=chunk) 2022 Non-Employee Director Compensation | Name | Fees in Cash ($) | Stock Awards ($) | Option Awards ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | | **L Panaccio**, Chairman | 126,250 | 87,494 | 31,248 | 244,992 | | **J Curnock Cook** | 90,833 | 87,494 | 31,248 | 209,575 | | **S Crowe** | 95,000 | 87,494 | 31,248 | 213,742 | | **J Reed** | 92,500 | 87,494 | 31,248 | 211,242 | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=53&type=section&id=Item%2012.%20SECURITY%20OWNERSHIP%20OF%20CERTAIN%20BENEFICIAL%20OWNERS%20AND%20MANAGEMENT%20AND%20RELATED%20STOCKHOLDER%20MATTERS) No beneficial owners hold over 5% of common stock, while all executive officers and directors as a group own 4.21% - There are **no known beneficial owners of more than 5%** of the company's common stock as of January 31, 2023[347](index=347&type=chunk) Beneficial Ownership of Management (as of Jan 31, 2023) | Holder | Percentage of Class | | :--- | :--- | | **Michael Perry** (Former CEO) | 1.01% | | **All executive officers and directors as a group (13 persons)** | 4.21% | - As of January 31, 2023, the company had **25,296,086 shares** of common stock outstanding, with a significant portion held as CDIs on the ASX[356](index=356&type=chunk) [Certain Relationships and Related Party Transactions, and Director Independence](index=58&type=section&id=Item%2013.%20CERTAIN%20RELATIONSHIPS%20AND%20RELATED%20PARTY%20TRANSACTIONS%2C%20AND%20DIRECTOR%20INDEPENDENCE) The company reports no material related party transactions and confirms the independence of all board members except for the CEO - The company has not participated in any related party transaction involving more than **$120,000** since January 1, 2021[375](index=375&type=chunk) - All members of the Board of Directors are considered independent, **except for James Corbett**, who serves as the company's Chief Executive Officer[376](index=376&type=chunk) [Principal Accounting Fees and Services](index=58&type=section&id=Item%2014.%20PRINCIPAL%20ACCOUNTING%20FEES%20AND%20SERVICES) Total fees billed by auditor Grant Thornton LLP for 2022 were $740,013, covering audit and tax services Principal Accountant Fees (Year-Ended Dec 31, 2022) | Service | Fees ($) | | :--- | :--- | | Audit Fees | 652,732 | | Tax Fees | 87,281 | | **Total Fees** | **740,013** | - All audit and non-audit services provided by the independent registered public accounting firm were **pre-approved by the Audit Committee**[380](index=380&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=59&type=section&id=Item%2015.%20EXHIBITS%2C%20FINANCIAL%20STATEMENT%20SCHEDULES) This section lists all documents filed with the report, including financial statements, material contracts, and corporate governance documents - This item provides an index of all financial statements, schedules, and exhibits filed with the Form 10-K[382](index=382&type=chunk) - Exhibits include corporate governance documents, material contracts (including the BARDA agreement), lease agreements, and executive compensation plans and agreements[384](index=384&type=chunk)[385](index=385&type=chunk) [Form 10-K Summary](index=61&type=section&id=Item%2016.%20Form%2010-K%20Summary) This section is noted as 'None', indicating no summary is provided - No Form 10-K summary is provided[387](index=387&type=chunk)

AVITA Medical, Inc. (NASDAQ:RCEL) Q3 2022 Earnings Conference Call November 10, 2022 4:30 PM ET Company Participants Caroline Corner - Managing Director, Investor Relations Jim Corbett - Chief Executive Officer Michael Holder - Chief Financial Officer Conference Call Participants Charlie Montang - Lake Street Capital Matthew O’Brien - Piper Sandler Ryan Zimmerman - BTIG Joshua Jennings - Cowen Madeleine Williams - Wilsons Operator Good day and thank you for standing by and welcome to AVITA Medical Third Qua ...