EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2023-11-15
Management highlights
John Mastrototaro:
- Less than 1 week away from Evie Ring launch, a result of over 2 years of research. Submitted 510(k) to FDA for Pulse Oximetry feature, with ongoing communication with FDA. Ongoing blood pressure and glucose initiatives, including a 44-person clinical trial showing accuracy within FDA standards for cuffless blood pressure wearable.
Tyler Bucher:
- Pre-launch marketing campaign with engaged leads list over 120,000, new commercial website launched with over 200,000 site visits, teaser campaign live across channels, preparations for CES exhibition, and focus on customer service for brand loyalty.
Blood pressure and glucose:
- Completed a 44-person clinical trial validating accuracy of cuffless blood pressure wearable, working on reconfiguring prototype into commercial form factor and additional clinical trials.
Segment performance
No detailed product segment financial performance with absolute terms and revenue contribution % provided in the transcript.
Guidance
Forward-looking statements:
- Expect healthy response to Evie Ring launch based on engaged leads, website traffic, and social media activity. B2B partnership opportunities expected to ramp up with final ring and app solution. Plan to formally reply to FDA letter in Q1 2024.
Risks
Risks discussed:
- FDA requirements for cybersecurity assessment and updating filings to new standards. Dependence on successful market reception of Evie Ring. Uncertainties related to capital markets and ability to sustain investment in product development.
Q&A highlights
Q: What are your expectations of sales for the Evie Ring this year?
A: Tyler and Stacy mentioned an engaged leads list of over 120,000, website traffic growth, and social media response indicating a healthy response to launch.
Q: Any more detail you could give us on your interaction with the FDA?
A: John discussed FDA scrutiny on pulse oximetry accuracy, cybersecurity assessment needed due to new guidance, and ongoing communication with FDA for submission updates.
Q: How will customers who are early adopters get access to additional upgrades?
A: Stacy said updates will be accessed through the app with firmware or app downloads.
Q: Where stand with potential strategic partners?
A: John mentioned ongoing engagement with beta partners, new large groups (insurer payer and remote patient monitoring company), and B2B partnerships expanding.
Q: What is your trial results for blood pressure and timeline for commercialization?
A: John discussed trial results showing accuracy, form factors (wrist worn currently), and timeline involving reconfiguring prototype, clinical trials, and pivotal trial for FDA clearance.
Q: Thoughts on working with large consumer electronics companies?
A: John said open to opportunities like white labeling or selling chips if in best interests of shareholders and customers.
Q: Positioned to invest behind Evie launch?
A: Jay mentioned interest, lead list, website traffic, and revenue generation from Evie launch will bolster balance sheet.
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
|---|---|---|---|---|
| EPS | — | — | — | — |
| Revenue | — | — | — | — |
Transcript
November 15, 2023Full transcript unavailable for redistribution
The structured summary above covers the available call sections. Full transcript text is not included on this page.
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Prior quarters
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