Q3 2024 iRhythm Technologies Inc Earnings Call Transcript
Key Points
- iRhythm Technologies Inc (IRTC) reported $147.5 million in revenue for the third quarter of 2024, representing an 18.4% growth year over year.
- The company achieved record demand from existing accounts and a record number of new account openings, indicating strong market traction.
- iRhythm Technologies Inc (IRTC) celebrated its one millionth patient registered for the ZO monitor, showcasing the product's widespread adoption.
- The company received FDA clearance for the first of two 510(k) submissions related to its Z system, indicating progress in regulatory compliance.
- International expansion efforts are underway, with commercial launches in Austria, the Netherlands, Switzerland, and Spain, as well as regulatory approval in Japan.
- iRhythm Technologies Inc (IRTC) is facing significant challenges with ongoing and legacy quality and regulatory issues, including a 2023 FDA warning letter and recent 483 observations.
- The company is voluntarily delaying regulatory submissions for its ZCT system, pushing the expected filing to the third quarter of 2025.
- Incremental legal and consulting fees related to FDA remediation efforts and DOJ subpoena activities are expected to cost approximately $11 million to $13 million in 2024.
- Adjusted net loss for the third quarter of 2024 was approximately $39.2 million, compared to a loss of $24.1 million in the third quarter of 2023.
- The delay in the MCT product submission is expected to impact revenue growth, as it was anticipated to contribute significantly in 2025.
Hello, everyone and welcome to iRhythm's third quarter, 2024 earnings call. My name is Lydia and I'll be your operator today. After the prepared remarks, you will have the opportunity to participate in the Q&A with the management team to keep the questions. Please press star followed by one on your telephone keypad.
I'll now hand you over to Stephanie Zhadkevich, Director of Investor Relations at Irhythm to begin. Please go ahead, Stephanie.
Thank you all for participating in today's call. Earlier today. I RMM released financial results for the third quarter, ended September 30, 2024. Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1,995.
Any statements contained in this call that are not statements of historical facts should be deemed to be
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