Financial Data and Key Metrics Changes - The company reported commercial revenues of $11.7 million for Q2 2023, representing a 42% increase compared to $8.2 million in the same period in 2022, and at the top end of the guidance range of $10.7 million to $11.7 million [26][60] - The gross profit margin was 81%, down from 83% in the same period in 2022, primarily due to decreased product production in one month of the quarter [39] - The net loss for the quarter was $10.4 million, or a loss of $0.41 per share, compared to a net loss of $6.3 million, or a loss of $0.25 per share in the same period in 2022 [63] Business Line Data and Key Metrics Changes - The increase in commercial revenue was largely driven by broader surgeon usage and deeper penetration, particularly within smaller burn procedures [52] - The company achieved two landmark FDA approvals and a pivotal FDA submission, which are critical for advancing its platform and unlocking growth potential [25] Market Data and Key Metrics Changes - The expansion into trauma centers allows the commercial team to capture a larger portion of the burn market, with an initial target market of approximately 127,000 eligible soft tissue repair procedures and 35,000 eligible burn procedures, representing a total addressable market (TAM) of over $1.2 billion [43] - Japan represents a majority of the foreign revenue line item, with over 90% of international revenue coming from this market [102] Company Strategy and Development Direction - The company is expanding its focus from burn centers to include hospitals, trauma centers, and outpatient settings, with plans to build out its portfolio and explore external business development opportunities [20] - The company is increasing its 2023 annual revenue guidance from $49 million to $51 million, now expecting a range of $51 million to $53 million, reflecting a 53% growth over 2022 at the midpoint of guidance [37][64] Management's Comments on Operating Environment and Future Outlook - Management expressed bullishness about the remainder of the year and 2024, citing early momentum and preparation for new approvals [13] - The company plans to provide 2024 guidance in February 2024, indicating a solid balance sheet and ongoing development of its 2024 plan [51][77] Other Important Information - The company initiated the expansion of its commercial organization, more than doubling its team from 30 to 70, which will result in peak operating expenses as a percentage of revenue in Q3 2023 [47] - The RECELL GO product is expected to significantly ease the burden of training required for physicians and operating room staff, leading to increased adoption across indications [80] Q&A Session Summary Question: Can you provide insight on the broader label secured for soft-tissue data and the potential rethinking of the commercial organization structure? - Management indicated that there are numerous applications under full-thickness skin defects that create a much bigger opportunity, and they plan to assess these before rushing into new initiatives [56] Question: What is the expected timeline for new sales reps to reach productivity levels? - It was noted that new sales reps typically take three to six months to reach cost coverage, with five resale kits per month needed to break even [101] Question: How does the company view margins longer term with the introduction of RECELL GO? - Management expects margins to increase as sales volume grows, potentially approaching 90% margins if sales align with expectations [106] Question: What specific cases are doctors most comfortable with regarding the new indication for full-thickness skin defects? - Management mentioned that cases like degloving and necrotizing fasciitis are being captured quickly, indicating a positive early adoption trend [107]
AVITA Medical(RCEL) - 2023 Q2 - Earnings Call Transcript