Release Date: February 20, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Could you elaborate on the guidance for 2025, considering the multiple catalysts like record account openings and Epic integration? A: Daniel Wilson, CFO: For 2025, we see several growth drivers, including balanced growth across multiple areas. However, we are cautious due to potential headwinds like low single-digit pricing pressure and competitive disruptions. We aim to maintain a balanced approach while being optimistic about the business momentum.
Q: How has the momentum from 2024 continued into 2025, and what trends are you seeing in the first quarter? A: Quentin Blackford, CEO: We saw growth increase every quarter in 2024, driven by new channels like primary care. While we had some benefits from new channel partners in Q4, we want to see sustained contributions before adjusting our guidance. The ZOAT side remains promising, and we are monitoring market disruptions.
Q: Can you update us on the progress with the FDA remediation efforts and the 483 observations? A: Quentin Blackford, CEO: We are making significant progress and aim to complete remediation activities by mid-2025. We maintain regular communication with the FDA and have met all deliverables. We are also conducting an independent review to ensure high standards.
Q: What is the status of the Z1CT timelines, and do you need to wait for the 483 remediation before submitting for approval? A: Quentin Blackford, CEO: We are on track to submit Z1CT for approval in Q3 2025. The 483 remediation does not need to be fully completed before submission. We prioritized critical remediation activities to demonstrate our commitment to the FDA.
Q: How is the Epic integration progressing, and what impact is it having on demand generation? A: Quentin Blackford, CEO: The Epic integration has been successful, improving workflow efficiency and customer satisfaction. We are seeing positive anecdotal signs of volume uplift, but we need more data before adjusting forward-looking expectations. The integration is expected to enhance patient care and increase volumes.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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