UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 07, 2025 AVITA Medical, Inc. (Exact name of Registrant as Specified in Its Charter) FORM 8-K (State or Other Jurisdiction of Incorporation) CURRENT REPORT 28159 Avenue Stanford Suite 220 Valencia, California 91355 (Address of Principal Executive Offices) (Zip Code) Delaware 001-39059 85-1021707 (Commission Fil ...

VALENCIA, Calif., Feb. 13, 2025 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a leading therapeutic acute wound care company delivering transformative solutions, today reported financial results for the fourth quarter and full year ended December 31, 2024. Fourth Quarter 2024 Financial Highlights and Recent Business Updates Commercial revenue of $18.4 million, an increase of approximately 30% compared to the same period in 2023Gross profit margin of 87.6%On December 19, 2024, the FDA gra ...

Article Summary - The article discusses AVITA Medical (NASDAQ: RCEL) and references a previous article published on January 2nd [2] - The timing of the previous article was noted as unfortunate due to a recent sales update [2] Disclosure Information - The author has no stock, option, or derivative positions in any mentioned companies and no plans to initiate such positions within the next 72 hours [2] - The article expresses the author's own opinions and is not influenced by compensation or business relationships with mentioned companies [2]

Company Overview - Avita Medical (NASDAQ: RCEL) is a biotechnology company specializing in regenerative skin treatments [1] Recent Developments - The company has received approvals for two new products: Cohealyx and RECELL GO mini since May [1] Analyst Background - The author holds a PhD in computer applications and has professional collaborations with another Seeking Alpha author [1]

On Tuesday, Avita Medical, Inc. RCEL revised its revenue guidance for the fourth quarter and full year of 2024.The regenerative medicine company adjusted its projections due to slower-than-expected purchasing by hospital accounts.Avita, which specializes in wound care and skin restoration, anticipates fourth-quarter commercial revenue of approximately $18.4 million. It reflects a 30% year-over-year increase. However, this is below its earlier guidance of $22.3 million to $24.3 million and consensus of $23.1 ...

VALENCIA, Calif., Dec. 23, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ:RCEL, ASX: AVH)), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced that the U.S. Food and Drug Administration (FDA) has approved its premarket approval (PMA) supplement for RECELL GO® mini. As a line extension of the RECELL GO system, the RECELL GO mini disposable cartridge is designed specifically to treat smaller wounds up to 480 ...

VALENCIA, Calif., Nov. 25, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced that Jim Corbett, Chief Executive Officer, will present at the at the Piper Sandler 36th Annual Healthcare Conference on Tuesday, December 3, 2024, at 11:30 a.m. Eastern Time. A live webcast of the fireside chat will be accessible under the Events & Presentations sec ...

VALENCIA, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a company specializing in commercial-stage regenerative medicine and pioneering devices for wound care management and skin restoration, today announced it has entered into an exclusive distribution agreement with Revolution Surgical Pty Ltd. This agreement marks an important milestone in our expansion into the Australian and New Zealand markets. Under the terms of the agreement, Revolution Surgical will serve a ...

Financial Data and Key Metrics - Q3 2024 commercial revenue reached $19.5 million, a 29% increase from Q2 and 44% year-over-year growth [5][23] - Gross profit margin for Q3 was 83.7%, slightly down from 84.5% in Q3 2023, due to ongoing engineering and validation of RECELL GO [25] - Net loss for Q3 was $16.2 million, or $0.62 per share, compared to a net loss of $8.7 million, or $0.34 per share, in Q3 2023 [28] - Cash, cash equivalents, and marketable securities stood at $44.4 million as of September 30, 2024, down from $89.1 million at the end of 2023 [28] Business Line Data and Key Metrics - 75% of the revenue base transitioned to RECELL GO by the end of September 2024, just four months after FDA approval [7] - 23 new account conversions for full-thickness skin defects were achieved in Q3, below the initial expectation of 40-50, but the total number of accounts now stands at approximately 300, more than double the number from a year ago [8] - RECELL GO Mini, designed for smaller wounds up to 480 square centimeters, is on track for approval by year-end 2024, with a launch expected in early 2025 [19] Market Data and Key Metrics - The company estimates it holds approximately 20% of the burn market, with a clear path to doubling that share over time through RECELL GO adoption [11] - The total addressable market for RECELL-eligible cases in the burn market alone is estimated at nearly $1.5 billion in the US [16] - International expansion is progressing, with CE mark approval for RECELL GO expected by Q1 2025, enabling entry into Europe and Australia [20] Company Strategy and Industry Competition - The company is focusing on converting its business to the RECELL GO platform, which offers significant workflow efficiencies, reduces operating room time, and accelerates patient healing [6][10] - Cohealyx, a collagen-based dermal matrix, is expected to receive FDA clearance by year-end 2024, with a launch planned for 2025 [12][18] - The company plans to use RECELL, PermeaDerm, and Cohealyx together as a comprehensive treatment solution for full-thickness wounds, improving patient outcomes and streamlining clinician experience [12][15] Management Commentary on Operating Environment and Future Outlook - Management is confident in achieving cash flow break-even and profitability by Q3 2025, driven by strong revenue growth and operational efficiencies [23][30] - The company expects Q4 2024 commercial revenue to be in the range of $22.3 million to $24.3 million, representing 14% to 25% sequential growth and 58% to 72% year-over-year growth [30] - The upcoming launches of Cohealyx and RECELL GO Mini, along with expanded adoption of PermeaDerm, are expected to drive strong financial results and create lasting shareholder value [30] Other Important Information - The company completed Project Phoenix, a manufacturing facility upgrade, which increased capacity by 10x and improved engineering capabilities [38] - The Vitiligo TONE Study and health economic study have been submitted for publication, with payer activity expected to begin in 2025, leading to potential coverage policies by the end of 2025 [21][61] Q&A Session Summary Question: Hospital VAC Process and Sales Team Performance - The company deliberately focused on accelerating RECELL GO conversions, which impacted the number of new account approvals through the VAC process [33] - The sales team is performing well, with 29.6 consecutive quarters of growth, and the company expects a strong Q4 [35] Question: RECELL GO Mini Adoption and Manufacturing Capacity - RECELL GO Mini is expected to accelerate adoption by better matching the device size to the wound size [37] - Manufacturing capacity has been significantly expanded through Project Phoenix, ensuring the company can meet growing demand [38] Question: Growth Drivers and Gross Margin Impact - The company has multiple growth drivers, including RECELL GO, RECELL GO Mini, PermeaDerm, and Cohealyx, which will contribute to revenue growth without significantly increasing operating expenses [40] - While Cohealyx and PermeaDerm have lower gross margins than RECELL, their operating margin contribution is substantial due to minimal additional operating expenses [42] Question: Q4 Guidance and CE Mark Delay - Q4 revenue guidance reflects strong growth in the burns business, driven by RECELL GO adoption [45] - The CE mark delay is not expected to significantly impact growth expectations for 2025, as international expansion is still in the early stages [47] Question: RECELL GO Mini Rollout and Outpatient Use - RECELL GO Mini will be rolled out in Q1 2025, targeting trauma centers and smaller wounds, with potential for outpatient use [49][56] Question: Cohealyx Post-Market Study and Vitiligo Timeline - The Cohealyx post-market study will focus on demonstrating faster time to graft readiness and wound closure compared to competitors [54] - Vitiligo revenue is expected to be a 2026 event, with studies expected to be published by the end of 2024 or early 2025 [61]

| --- | --- | --- | --- | --- | |------------------|-------|-------|-------|-------| | | | | | | | | | | | | | Q3 2024 Earnings | | | | | | Presentation | | | | | | November 7, 2024 | | | | | Forward-Looking Statements & Legal Disclaimers 2024.Q4 v9 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 ...