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Jun 30, 2024
AVITA Medical Q2 2024 Earnings Report
Reported a record commercial revenue of $15.1 million, FDA approved RECELL GO, and submitted PMA supplement for RECELL GO mini.
Key Takeaways
AVITA Medical reported a 29% increase in commercial revenue, reaching $15.1 million for the second quarter of 2024. The company also achieved FDA approval for RECELL GO and submitted a PMA supplement for RECELL GO mini. A new agreement with Regenity Biosciences was entered into to commercialize a collagen-based dermal matrix.
Commercial revenue reached $15.1 million, a 29% increase compared to the same period in 2023.
Gross profit margin was 86.2%.
RECELL GO™ premarket approval (PMA) supplement was approved by the FDA on May 29, 2024.
PMA supplement for RECELL GO mini™, designed to address smaller wounds, was submitted on June 28, 2024.
Forward Guidance
The company expects commercial revenue for the third quarter of 2024 to be in the range of $19.0 to $20.0 million, representing growth of approximately 40% to 48% over the same period in 2023. Full-year 2024 commercial revenue is expected to be in the range of $68.0 to $70.0 million, reflecting growth of approximately 37% to 41% over the full-year 2023. The company expects to achieve cashflow break even and GAAP profitability no later than the end of the third quarter of 2025.
Positive Outlook
- Regenity is expected to receive 510(k) clearance for the dermal matrix in the fourth quarter of 2024, after which AVITA Medical will begin marketing, selling, and distributing.
- Multiple post-market clinical studies are planned to establish synergies between the new dermal matrix and RECELL.
- FDA approval of RECELL GO mini is anticipated by December 27, 2024.
- Post-market study (TONE) treating patients with stable vitiligo and a separate health care economics study are expected to be submitted for publication by year-end.
- Sequential third-quarter commercial revenue growth between 26% to 32% over the second quarter is anticipated.
Challenges Ahead
- Full-year revenue guidance was adjusted downward, though it still reflects a growth rate of over 37% year-over-year.
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