Release Date: August 06, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Revenue for the second quarter of 2024 totaled $44.1 million, showing an 18.7% quarter-over-quarter growth, indicating a stabilization in global demand.
- The FDA conducted a pre-approval inspection of the company's manufacturing facility in Costa Rica, with only minor observations, suggesting imminent approval for Motiva Implants in the US.
- The company has seen a strong recovery in demand in the EMEA and APAC regions, with several markets fully rebounding from previous slowdowns.
- Adjusted EBITDA loss was reduced to approximately $4 million, less than half of what was reported in the second quarter of last year, showing improved financial management.
- The company is preparing for a US launch with a strong team and infrastructure in place, anticipating significant growth and profitability from the US market entry.
Negative Points
- Total revenue for the second quarter declined by 9.3% from the year-ago period, indicating challenges in maintaining year-over-year growth.
- The Brazilian market continues to suffer from softer demand, with no expected improvement this year, impacting overall performance in Latin America.
- Despite improvements, the company still reported a net loss from operations of $9.3 million for the second quarter.
- Foreign exchange rates, particularly the strengthening of the Costa Rican Colón, continue to be a headwind, affecting reported costs.
- The company is still facing challenges in onboarding clinics quickly enough for the Mia Femtech product, which could delay revenue growth from this segment.
Q & A Highlights
Q: What factors contribute to your confidence in the current revenue guidance, especially with the US approval on the horizon?
A: Raj Denhoy, CFO: We provide guidance based on current market dynamics. While Brazil remains weak, we're confident in US approval, which is factored into our guidance. We expect a return to a more normalized seasonal pattern in the third quarter, with Brazil tracking lower but US approval boosting confidence.
Q: Can you elaborate on the nature of the FDA's 483 observations and your confidence in addressing them?
A: Juan Jose Chacon Quiros, CEO: The observations are minor and isolated, such as the timing of medical device report submissions and employee training tracking. We've responded quickly, and these issues should not affect our approval timeline.
Q: What does the early launch phase for Motiva in the US look like, and how is the team prepared?
A: Juan Jose Chacon Quiros, CEO: We have an all-star team ready, led by Jeff Ehrhardt. We've already begun manufacturing the first batch of Motiva implants for the US. The back office is prepared, and we are ready to ship and invoice quickly post-approval.
Q: How is Mia Femtech performing, and what are the dynamics at the centers offering it?
A: Juan Jose Chacon Quiros, CEO: Mia is expanding into 22 cities with 63 certified surgeons. Nearly half of the women treated were not considering traditional augmentation, indicating market expansion. We aim for clinics to reach 24 cases per month, translating to significant revenue.
Q: How does FDA approval impact international adoption, particularly in CE Mark countries?
A: Juan Jose Chacon Quiros, CEO: FDA approval is seen as a gold standard, influencing conservative surgeons globally. This approval, combined with our clinical trial results, will likely boost adoption in Europe, Latin America, and Asia, where some surgeons have awaited FDA clearance.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
