EBR Systems (EBR) Q3 2024 TU earnings summary

Executive summary

• Submitted final PMA module for WiSE CRT System to FDA in August 2024; FDA accepted and began substantive review as of 29 August 2024.

• Anticipates FDA approval in Q1 2025 and commercial launch later in 2025, targeting a $3.6bn US market.

• Raised A$50m through institutional and retail offerings to fund manufacturing scale-up and commercialization.

• Cash and short-term investments totaled US$74.2m as of 30 September 2024.

• Became a US public reporting company in addition to ASX listing, with SEC Form 10 effective 30 September 2024.

Financial highlights

• Net loss for Q3 2024 was $10.1m, up 10.1% year-over-year; nine-month net loss was $30.7m, up 24.2% year-over-year.

• Operating expenses for Q3 2024 were $9.2m, up 4.4% year-over-year; nine-month operating expenses were $28.5m, up 16.9%.

• Research and development expenses for Q3 2024 decreased 9.5% to $6.3m; general and administrative expenses increased 56.6% to $2.9m.

• Cash used in operations for the nine months ended 30 September 2024 was $30.2m, compared to $23.2m in the prior year period.

• Cash and cash equivalents at 30 September 2024 were $36.4m, with $37.8m in marketable securities.

Outlook and guidance

• Expects FDA approval for WiSE CRT System in Q1 2025 and initial US commercial revenue in 2025.

• Plans to expand US sales force and marketing to drive adoption post-approval.

• Anticipates increased R&D and G&A expenses as commercialization and regulatory activities ramp up.