IceCure(ICCM) - 2022 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Revenue for Q1 2022 decreased by 48% to approximately $0.75 million compared to $1.4 million in Q1 2021, primarily due to decreased revenue recognition from the distribution agreement with Terumo and a decline in sales in the Asia region impacted by COVID surges [17][24] - Gross profit was approximately $0.44 million for Q1 2022, down from approximately $0.94 million in the same period last year, with a gross margin of approximately 58% compared to 65% in Q1 2021 [18] - Net loss for Q1 2022 increased to approximately $4.4 million, or $0.12 per share, compared to a net loss of approximately $1.4 million, or $0.07 per share, for the same period last year [24] Business Line Data and Key Metrics Changes - Sales in the U.S. increased in Q1 2022, with ProSense receiving positive feedback at major oncology conferences [9] - The company has installed several new ProSense systems globally, indicating a strong commercial presence in 20 countries [7][8] Market Data and Key Metrics Changes - The decrease in revenue recognition from the Terumo distribution agreement was a significant factor in the overall revenue decline, particularly affecting markets in Japan, Singapore, and Thailand [17][66] - The company expects to have probe approval in China by September or October 2022, despite COVID-related delays [41] Company Strategy and Development Direction - The company is focused on obtaining FDA approval for ProSense in early-stage breast cancer, with plans for a De Novo classification and a sprint discussion with the FDA [13][38] - IceCure aims to expand its commercialization efforts and enhance its clinical applications with its cryoablation technology [3][16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about future revenue growth due to international distribution agreements and increased sales efforts [16] - The company is working closely with the FDA and expects to finalize its submission for early-stage breast cancer treatment by early 2024 [59] Other Important Information - Research and development expenses increased to $2.4 million in Q1 2022, attributed to the acceleration of the next-generation single-probe system development [19][20] - Selling, marketing, general, and administrative expenses rose to $2.5 million, reflecting the company's expanding commercialization efforts [22] Q&A Session Summary Question: Update on FDA submission and timeline - Management confirmed ongoing discussions with the FDA and plans to submit for clearance for cryoablation of early-stage breast cancer operations who are high risk for surgery [36][38] Question: Impact of COVID on NMPA clearance in China - Management expects probe approval by September or October 2022, with minimal delays anticipated due to COVID lockdowns [41] Question: Operating expenses outlook - Operating expenses are expected to remain at current levels due to accelerated R&D efforts [42][43] Question: Receptiveness to cryoablation among colleagues - There is significant excitement and recognition of cryoablation as a viable alternative to surgery among medical professionals [45][48] Question: Timeline for registry implementation - The goal is to start the registry towards the end of summer or beginning of fall 2022 [73] Question: Ongoing NASDAQ listing costs - Management indicated that NASDAQ-related costs are expected to remain elevated due to rising insurance costs [74]