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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.
AVITA Medical
AVITA Medical
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.
- Net loss was $15.4 million, or a loss of $0.60 per basic and diluted share, compared to a net loss of 10.4 million, or a loss of $0.41 per basic and diluted share, in the same period in 2023.
- BARDA income decreased to zero, compared to $0.5 million in the corresponding period in the prior year due to the ending of reimbursable clinical trials.
- Total operating expenses for the quarter were $28.7 million, compared to $21.2 million in the same period in 2023.
- Interest expense increased approximately $1.3 million in comparison to the same period in the prior year due to the interest expense related to the long-term debt