AVITA Medical, Inc. Q1 FY2025 earnings call

• Launched RECELL GO mini in February 2025 for trauma centers treating smaller wounds. - Launched Cohealyx nationwide on April 1, 2025, with positive clinical feedback from initial cases. - Fully implemented manufacturing of PermeaDerm at Ventura, California facility and amended distribution agreement with Stedical Scientific, increasing AVITA's revenue share to 60% from 50%. - Evolved commercial model, consolidating regions, reducing field headcount, and realigning incentives to support portfolio transformation. - CMS proposed NTAP for RECELL, optimistic about approval. - Paused commercial investment in vitiligo indication due to reimbursement uncertainty, focusing on acute wound care.

For the three months ended March 31, 2025, commercial revenue was $18.5 million, a 67% increase compared to Q1 2024. Gross profit margin for the first quarter was 84.7% down from 86.4% in the same period of 2024. The decrease in overall gross margin was due to volume discounts, higher inventory reserve, and product mix. The portfolio includes RECELL GO mini, Cohealyx, and PermeaDerm, with the US addressable market expanding from ~$500 million to over $3.5 billion annually.

• Full year 2025 commercial revenue guidance: $100 million to $106 million, representing 55%-65% growth from 2024. - Expect to generate free cash flow in the second half of 2025 and achieve GAAP profitability in Q4 2025, supported by operating efficiencies and scaling of commercial portfolio. - Confident in success of RECELL GO, Cohealyx full launch, RECELL GO mini rollout, and PermeaDerm adoption.

• Uncertainty in vitiligo reimbursement landscape, leading to pause in commercial investment. - Potential impact of tariff policies, but current tariffs not expected to materially affect business.

Q: Could you share anecdotally about the response and performance of Cohealyx from its limited commercial launch and pending full launch?

A: Limited launch in Q1 gathered case data, validated 7-day graft readiness at Ohio State, and Cohealyx is fully stocked with 700 square centimeter sheets available. Post-market study is majority ready to enroll.

Q: Any sense of RECELL GO mini's response in Level 1 and Level 2 trauma centers?

A: Good response from existing VAC approved accounts in trauma area, with RECELL GO mini covering wounds under 2.5% total body surface area, and the portfolio providing more value to trauma surgeons.

Q: Potential revenue contributions from Cohealyx launch and target attachment rates?

A: Cohealyx is expected to be a material contributor, with potential to breakout non-RECELL sales by Q3. Not ready to give specific mix guidance yet.

Q: Regarding sales force to reach revenue targets, is it in place?

A: Sales force is reconfigured, with clinical specialists converted to sales associate roles, and a selling-oriented model trained, feeling good about staffing level to reach targets.

Q: Cadence of revenues through rest of 2025?

A: Expect sequential growth every quarter, with some weighted towards back end as Cohealyx gains more VAC approvals.

Q: Clarification on vitiligo initiative and reimbursement?

A: Paused spending on vitiligo due to reimbursement uncertainty in office-based lab setting, no revenue dependence in future estimates until defined plan is established.