IceCure Medical (ICCM) Q3 Earnings call transcript Nov 26, 2024

IceCure Medical, a leading player in the cryoablation market, recently held its third quarter 2024 earnings call to review its financial results and provide updates on its operational highlights. The call was marked by a positive outlook on the company's performance, highlighted by significant growth and milestones reached.

Financial Performance and Global Adoption of Cryoablation System

The financial results for the first 9 months of 2024 showed a 36% increase in ProSense sales and a more than doubling of non-GAAP gross profit, indicating a strong demand for IceCure's cryoablation system worldwide. The impressive data from the ProSense system's clinical trials, published in prestigious peer-reviewed publications and presented at leading medical conferences, further bolstered the confidence of stakeholders and the medical community.

Potential Marketing Authorization in the U.S. and Japan

The FDA's recent positive outcomes from the ProSense system's advisory panel meeting have brought the company one step closer to marketing authorization, a milestone expected to be achieved in the first quarter of 2025. This development is significant as it would allow IceCure to offer women in the U.S. a non-surgical alternative to lumpectomy, potentially revolutionizing early-stage breast cancer treatment.

Simultaneously, IceCure's partner in Japan, Terumo Corporation, is expected to file for regulatory approval of the ProSense system for breast cancer in 2025. This move demonstrates the global recognition and demand for IceCure's innovative technology.

Strategic Partnerships and Ongoing Clinical Trials

IceCure's strategic partnership with Terumo Corporation and its commitment to ongoing clinical trials, including the PRECISE study, underscore the company's dedication to advancing cryoablation technology and addressing a broader range of indications. The results from these studies are expected to further solidify the safety and efficacy of the ProSense system, enhancing its market value and potential.

Future Outlook and Catalysts

Looking ahead, IceCure's pipeline of upcoming catalysts, such as the ICESECRET study and the expansion of the PRECISE study, positions the company for continued growth and success. The interim results from the ICESECRET study, expected in early December, will provide valuable insights into the system's performance in kidney cancer treatment, a significant opportunity for IceCure given the high unmet need in this area.

Conclusion

IceCure Medical's earnings call was a testament to the company's transformative year, marked by significant financial growth, regulatory milestones, and strategic partnerships. With a clear focus on innovation and addressing unmet needs in the medical community, IceCure is poised for continued success and growth, particularly with the expected marketing authorization for ProSense in the U.S. and Japan. The company's dedication to advancing cryoablation technology and expanding its application across various indications further solidifies its position as a leader in the field.