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AVITA Medical Reports Third Quarter Financial Results with 51% Revenue Growth over the Same Period the Prior Year
VALENCIA, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (the “Company”), a regenerative medicine company leading the
About this update from Avita Medical, Inc.
[{"type":"text","content":"VALENCIA, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (the “Company”), a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, today reported financial results for the third quarter September 30, 2023. Financial Highlights and Recent Updates Commercial revenue of $13.5 million, an approximately 51% increase compared to $9.0 million for the same period in 2022Gross margin of 84.5% for the quarterAnnounced international expansion plan; engaged first European distribution partner, PolyMedics Innovations GmbH, to lead expansion into Germany, Austria, and SwitzerlandIn October, secured a debt financing facility for up to $90.0 million, of which $40.0 million was borrowed at closing. Together with the cash on hand of $60.1 million as of September 30, 2023, the Company believes it has sufficient capital to meet its goals and to reach profitability during 2025. “We continue to execute our growth strategy, paving the way to profitability,” said Jim Corbett, Chief Executive Officer of AVITA. “We are diligently working through supplemental in-house testing to support the FDA’s review of our PMA supplement for RECELL GO. Once complete, we expect to submit a response to the FDA’s open questions on February 28, 2024. Under the Breakthrough Device program, we anticipate FDA approval on May 30, 2024, which positions us for a launch the following day.” Future Milestones Expect FDA real-time review of the PMA Supplement for RECELL GO™ to resume on March 1, 2024, day 91 of the 180-day review cycle, with FDA approval anticipated on May 30, 2024 Reaffirming high growth potential of full-thickness skin defect indication, which presents a market 10 times the size of original burns marketPlan to actively identify new international distributor partnerships, including Australia, Japan, and European Union, over the next 6 to 12 monthsExpect full enrollment of post-market study, TONE, by end of February 2024Initiating health care economics study to capture longitudinal healthcare costs of vitiligo patientsExpect initial reimbursement coverage for vitiligo in Q3 2025Expect to reach profitability in 2025 “We have achieved significant commercial revenue growth rates for the last three quarters of 40%, 42% and 51%, ...