IceCure Medical Ltd Q2 FY2026 earnings call

Strategic Transition to Commercial Growth

• Management identifies the first half of 2026 as a key inflection point, with prior investments in clinical evidence, regulatory milestones, and physician education now translating to measurable commercial momentum
• Clinical and commercial strategies have become mutually reinforcing: increasing adoption generates real-world evidence that builds physician confidence, supports reimbursement initiatives, and drives further adoption, creating a self-sustaining growth cycle

Clinical Progress

• The FDA-approved post-market CHOICE study is integrated into commercial strategy, rather than a separate pre-commercial activity: participating clinical sites purchase disposable probes for routine patient care while contributing clinical data, and many participating investigators have transitioned to active commercial users
• As of H1 2026, 2 sites have completed IRB approval and signed contracts, with more than 10 additional sites in the approval pipeline, and first patient enrollment is expected within 3-4 weeks
• Proceed has gained increased clinical recognition, including inclusion in the American Society of Breast Surgeons Resource Guide, new peer-reviewed publications, and a Society of Interventional Oncologists petition for inclusion in the NCCN Breast Cancer Guideline

Commercial Progress

• Following FDA clearance for early-stage low-risk breast cancer, the U.S. active commercial install base grew ~70% year-over-year to more than 30 active sites as of June 30, 2026
• The company is expanding its U.S. commercial organization with additional sales personnel and growing presence in select international markets
• In Japan, the company continues constructive engagement with leading physicians, medical societies, and strategic partners to advance long-term commercialization, with growing clinical interest despite extended regulatory timelines

Financial Position

• The company strengthened its balance sheet via a second quarter 2026 financing, ending H1 2026 with $12 million in cash and cash equivalents, providing full financial flexibility to execute growth strategy
• Total operating expenses increased in line with strategic investments: R&D expenses were $4.3 million (driven by CHOICE study initiation and FX impacts), sales and marketing expenses were $2.5 million (driven by U.S. commercial expansion), G&A expenses were $2.4 million (driven by FX impacts and higher share-based compensation)
• Net loss for H1 2026 was $8.8 million ($3.17 per share), compared to $7 million ($3.59 per share) in H1 2025

IceCure Medical operates two core product segments: IceSense3 (proceed) systems and single-use disposable probes. For the first half of 2026, total company revenue grew 45% year-over-year to $1.8 million, with growth across both segments. Disposable probes make up a stable share of total revenue with a slight year-over-year increase, reflecting higher utilization of installed systems by practicing physicians. System sales grew 20-25% year-over-year in H1 2026 while the number of leased/placed systems remained flat, meaning purchased systems now represent a larger percentage of total system revenue than in the prior year period. Gross profit for the total company increased to $548,000 in H1 2026 from $349,000 in H1 2025, with overall gross margin improving 200 basis points to 30% year-over-year.

• Management confirms the company remains on track to meet all FDA-mandated CHOICE study milestones, including first patient enrollment by early September 2026 and enrollment of 80 total patients by March 2027
• The CPT-1 reimbursement code for breast cancer cryoablation is scheduled to be reviewed at the September 2026 AMA meeting, per the public AMA meeting agenda
• Management expects Q3 2026 to be seasonally softer due to global summer vacations, and projects Q4 2026 will remain the company's strongest quarter of the year consistent with historical trends, with steady sequential growth across the second half of 2026 following the H1 revenue run rate of ~$900,000 per quarter

• Foreign exchange fluctuations (specifically between the Israeli shekel and U.S. dollar) negatively impacted gross margin in H1 2026, offsetting underlying operational margin improvements from higher revenue scale. FX fluctuations also increased R&D and G&A expenses for the period, as most of the company's cost base is Israel-based
• IRB approval for new CHOICE study sites can take between 3-7 weeks depending on whether sites use a central IRB or in-house IRB, creating potential variability in study enrollment timelines
• All forward-looking statements related to commercial adoption, study execution, regulatory progress, and reimbursement are subject to inherent risks and uncertainties, many of which are outside the company's control, as detailed in the company's Form 20-F filing with the SEC

Q: Has the mix of system purchases versus leases/placed systems changed year-over-year, and how does this impact reported revenue?

A: Compared to H1 2025, total system units sold grew 20-25% in H1 2026 while the number of leased/placed systems stayed flat. This means purchased systems now make up a larger percentage of total system revenue than last year, a trend management calls encouraging as it reflects sites committing to the technology for long-term commercial use, partially driven by CHOICE study sites purchasing systems to participate.

Q: Why was H1 2026 gross margin lower than expected, and what factors drove the result?

A: Minor mix change between probes and systems had a small impact, but the primary factor was negative foreign exchange fluctuations between the U.S. dollar and Israeli shekel. Without FX headwinds, gross margin would have seen a double-digit percentage increase compared to the prior year, driven by operating leverage from higher revenue scale.

Q: What is the timeline for the CPT-1 reimbursement code submission and upcoming review?

A: Per AMA confidentiality rules, management cannot confirm or comment on the submission itself. However, the public AMA meeting agenda lists breast cancer cryoablation CPT code review for the September 2026 AMA meeting, which matches the company's original planned timeline.

Q: What should investors expect for revenue trajectory in the second half of 2026?

A: Management does not provide explicit guidance, but notes Q3 is typically seasonally weaker due to summer vacations across Northern Hemisphere markets, while Q4 has historically been the company's strongest quarter of the year, implying sequential growth through the end of 2026 that builds on the ~$900,000 per quarter run rate established in H1 2026.