iRhythm Technologies (IRTC) Morgan Stanley 22nd Annual Global Healthcare Conference summary

Technology and strategic partnerships

• Announced a license agreement with BioIntelliSense to expand into multi-vital sign sensing, enabling pulse oximetry and sleep testing directly from a chest-worn device.

• Integration of BioIntelliSense technology will shift some internal R&D efforts, with full integration expected in 2025 and market launch in 2026 or later.

• The agreement is structured to avoid incremental operational spending, maintaining full-year financial guidance except for a one-time R&D charge.

• Partnerships with Epic (Aura) and Signify are expected to drive significant account integration and workflow efficiencies, with broader commercial launches planned for 2025.

• Primary care channel expansion is a key growth area, leveraging workflow tools and data insights from new technology.

Regulatory and quality remediation

• FDA remediation is the top priority, focusing on addressing Form 483 observations related to process documentation and the role of certified cardiac technicians (CCTs).

• The company has agreed to include CCTs in its quality system, aligning with the FDA's perspective and implementing leadership changes in quality management.

• Responses to the FDA were submitted on August 21, with an expected agency reply in 30-60 days; additional expert consultants have been engaged.

• MCT filing is targeted by year-end 2024 as part of the remediation plan, with the new platform addressing prior FDA concerns.

• The company is confident in its commitment to remediation and is working to avoid escalation to a warning letter or consent decree.

Product development and market expansion

• MCT platform leverages existing manufacturing automation, enabling efficient scaling and cost leverage; commercial launch is anticipated in late 2025.

• Every 10 points of MCT market share could add $80-100 million in annual revenue, with a long-term target of 20-30% share.

• Japan regulatory approval is expected soon, with reimbursement discussions and launch planned for early 2025; high medical needs designation is expected to drive adoption.

• Product is now available in Austria, Netherlands, Switzerland, and Spain, with reimbursement established or in progress; private sector sales are underway.

• Sleep apnea market entry is progressing, with pilots showing strong demand; broader rollout is expected after FDA remediation, with 2025 as a slow build year.