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 it has entered into an exclusive multi-year distribution agreement with Stedical Scientific, Inc. to commercialize PermeaDerm® Biosynthetic Wound Matrix in the United States. PermeaDerm is cleared by the Food and Drug Administration as a tran ...

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 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 or 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 organization) 28159 Avenue Stanford Suite 220 Valencia, CA 91355 (Address of principal ...