EBR Systems (EBR) investor relations material

Executive summary

• Q3 completed 40 commercial WiSE implants, versus 46 in Q2; cumulative pilot and Limited Market Release implants reached 157.

• Commercial strategy is shifting from broad site launches to focused field support and deeper penetration in existing accounts; benefits are expected to build through Q4 and into 2027.

• CEO assumed direct oversight of the commercial field team during the CCO search; management said the abrupt correction contributed to September’s decline.

Financial highlights

• Preliminary unaudited Q3 revenue expected at US$2.43M–US$2.53M, versus US$2.6M in Q2; figures remain subject to quarter-end adjustments.

Outlook and guidance

• Q4 priorities include strengthening commercial execution, expanding and training the U.S. field team, increasing utilization and procedural frequency, and transitioning manufacturing to Santa Clara.

• New site activations will be moderated, not halted; slower site and contract growth is expected, with more case growth from existing accounts and strengthened local support.

• Santa Clara activation and manufacturing cutover remain targeted for year-end; the expanded facility has potential annual capacity of 9,600 systems, representing ~US$607.6M in revenue potential.

• A Q4 CBE PMA supplement is planned to strengthen WISE labeling on echo-induced pacing risk; the CMS NCD is expected in early December, with April 1, 2027 as the anticipated effective date if approved.

• Australian TGA application is expected to be submitted shortly.