Shares of iRhythm Technologies Inc. (NASDAQ: IRTC) plummeted nearly 10% in pre-market trading on Wednesday, following the company's third-quarter earnings report that highlighted ongoing regulatory challenges and higher-than-expected losses, despite strong revenue growth.
The medical technology company reported revenue of $147.5 million for the quarter, representing an 18.4% year-over-year increase. However, the adjusted net loss widened to $39.2 million, or $1 per share, missing analyst estimates. The company attributed the larger losses to increased legal and consulting fees related to FDA remediation efforts and a DOJ subpoena.
Perhaps more concerning for investors was the news that iRhythm had voluntarily delayed regulatory submissions for its anticipated ZCT system, pushing the expected filing to the third quarter of 2025. The delay was prompted by the company's desire to address potential FDA questions, following a warning letter in 2023 and recent 483 observations.
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