IceCure Medical (ICCM) Q2 2024 earnings summary

Executive summary

• ProSense system and probe sales grew 20% year-over-year in H1 2024, driven by adoption in Europe, the U.S., Japan, and Asia, with China sales at zero due to local factors.

• Achieved all primary objectives for H1 2024, with strong patient and physician demand for minimally invasive breast cancer treatments.

• Multiple independent studies confirm high efficacy and safety of ProSense, with 100% ablation rates and no major complications in key studies.

• ProSense is approved for breast cancer in several global markets, with growing global demand and increasing adoption.

• Preparing for FDA Medical Device Advisory Committee review in Q4 2024 for early-stage, low risk breast cancer indication.

Financial highlights

• Total revenue for H1 2024 was $1.75 million, up from $1.65 million in H1 2023, mainly due to increased ProSense system and disposables sales.

• Gross profit rose to $799,000 (GAAP) and $699,000 (non-GAAP), with non-GAAP gross margin improving to 42% from 35% year-over-year.

• Operating expenses decreased to $7.68 million from $8.8 million, narrowing net loss to $6.7 million ($0.14/share) from $7.66 million ($0.17/share) year-over-year.

• Cash and cash equivalents were $10.5 million as of June 30, 2024, and $10.3 million as of July 31, 2024.

• Raised $5.035 million in gross proceeds from ATM facility in H1 2024.

Outlook and guidance

• FDA advisory panel for ProSense in early-stage breast cancer expected in Q4 2024, with a marketing clearance decision anticipated in Q1 2025.

• Terumo, the Japanese partner, plans to file for regulatory approval in Japan in Q1 2025.

• Interim analysis of ICESECRET kidney cancer trial expected in December 2024.

• Commercial rollout strategy in the U.S. post-FDA approval includes KOL engagement and society partnerships.

• Additional third-party data on ProSense anticipated from ongoing global studies.