IceCure Medical Ltd Q2 FY2025 earnings call

• Regulatory: FDA requested additional information around the post-market study for ProSense, which is to include 400 patients in 30 sites with recruitment within 3 years. Positive adoption in Europe for breast cancer cryoablation, with ProSense featured in medical forums and hands-on training courses sold out. 17-year follow-up data from over 600 breast cancer patients showed a 99% recurrence-free rate.
• Financial: Closed a $10 million oversubscribed rights offering, strengthening financial position.
• Clinical: Prominent clinical data from independent researchers and conferences highlighting ProSense's efficacy.

For the 6 months ended June 30, 2025, revenue was $1.25 million compared to $1.75 million in the same period of 2024. Gross profit for the first half was $349,000 compared to $799,000 in the prior year period, resulting in a gross margin of 28% versus 46% in the first half of 2024. Total operating expenses decreased to $7.39 million for the 6-month period compared to $7.68 million a year ago. As of June 30, 2025, cash, cash equivalents and short-term deposits were $5.38 million, including a $2 million loan from a major shareholder, and the $10 million gross proceeds from the rights offering closed on August 1, 2025.

• Optimistic about FDA approval for ProSense before year-end 2025.
• Revenue and gross profits may vary quarter-to-quarter as building commercial sales.
• Growth trajectory could accelerate upon FDA decision.
• Eyal and Ronen to present at H.C. Wainwright and Maxim conferences to raise awareness.

Forward-looking statements subject to risks and uncertainties outlined in the company's annual report on Form 20-F, including those beyond the company's control related to regulatory, clinical, and commercial initiatives.

Q: What's the nature of the additional information that FDA requested?

A: The FDA would like information around the post-market study, including list of potential participating sites, site qualification forms, and recruitment plan.

Q: And I mean just going through this exercise lead you to increase your budget for recruiting for the trial for instance? Or do you expect the cost of the trial to be about the same as you previously suggested?

A: We are working now to update the budget; the final budget will be decided when we have full understanding with the FDA regarding all requests, including CRO costs and follow-up payments.

Q: So just to follow up on the post-market study. So that's been submitted and accepted by the FDA in terms of the submission has been accepted, and now they're reviewing the protocol before making a final decision. Is that correct?

A: Yes, we provided all required information related to the post-market study, including intended use, IFU, indication, patient leaflet, recruitment plan, and are in continuous discussion with the FDA.

Q: And then just in terms of how IceCure is preparing for the potential acceptance of the post-market study and therefore, FDA approval. I know you've already implemented some steps and hired a few people. Is there anything else that you feel IceCure needs to do to prepare to hit the ground running once the decision has been made?

A: We've created traction with sites who are waiting for FDA approval and would like to participate in the post-market study and be commercial sites; we will look to hire new team members immediately after grant letter.

Q: So the sites have been selected, they will be both the sites that are part of the application for the post-market study, they'll also be commercial sites, and you're already starting to train the interventional radiologists and the breast surgeons or you're lining them up to be trained immediately following anticipated approval, correct?

A: Yes, sites see it as a great opportunity to provide additional data and be commercial users, and we are lining up training.

Q: So these conferences you expect to be able to drive new sales and utilization in Europe. Do you think that in addition to these conferences and the data that you have, do you think things will -- sales will accelerate in Europe following potential FDA approval? Do you think that will be an additional catalyst?

A: Yes, FDA approval will be an additional catalyst for sales acceleration in Europe.

Q: Could you add a little more detail about the specific patient population and cancer type and how that -- I think it was 1% recurrence rate you mentioned, compares with the historical expectation for those patients?

A: In Japan, standard of care for low-risk early stage breast cancer (Luminal A) with whole breast radiation leads to better recurrence rates; differences in standard of care between Japan, U.S., and Europe contribute to varying recurrence-free rates.

Q: And I guess I'm curious in terms of the commercial launch strategy that you have and you're in the process of preparing the contingency of the FDA approval. Would you -- is your current cash position sufficient to fund those operations through FDA clearance? Or are you planning you might need a little bit more funding for that?

A: Currently, we have enough funding to get the FDA authorization and past that; final cash demands will be determined when we finalize post-marketing study budgeting.