Profound(US:PROF)2021-11-07 05:05Financial Data and Key Metrics Changes - For Q3 2021, the company recorded revenue of $2.5 million, up 13% from $2.2 million in Q3 2020 [13] - Total operating expenses increased by 30% to $8.6 million compared to approximately $6.6 million in Q3 2020 [13] - The net loss for Q3 2021 was $6 million or $0.29 per share, compared to a net loss of $6.1 million or $0.33 per share in the same period of 2020 [15] Business Line Data and Key Metrics Changes - R&D expenses increased by 14% year-over-year to $4 million, driven by costs associated with clinical trials and MRI utilization [14] - G&A expenses rose by 35% to $2.5 million due to employee options and increased insurance costs [15] - Selling and distribution expenses surged by 72% to approximately $2 million [15] Market Data and Key Metrics Changes - TULSA-PRO procedure volumes in the U.S. grew 20% sequentially from Q2 to Q3 2021, indicating a developing trend [17] - The company expects to have approximately 20 U.S. installed sites by year-end, down from a previous estimate of 25 due to COVID-related delays [22] Company Strategy and Development Direction - The company is focusing on building a high-quality U.S. installed base by targeting early adopters, independent imaging centers, and leading teaching hospitals [19] - The strategy includes optimizing the onboarding process to reduce installation times post-pandemic [23] - The company is progressing with its reimbursement strategy, planning to file for a CPT code application in 2022 [30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the long-term growth potential despite COVID-related challenges, citing strong utilization trends [18] - The company anticipates that delays in installations will diminish by year-end, allowing for a more robust growth trajectory in 2022 [23] - Management highlighted the importance of clinical data in supporting reimbursement applications and driving adoption [30] Other Important Information - The company has received FDA approval under Humanitarian Device Exemption for the treatment of osteoid osteoma, marking a significant milestone [8] - The interim results of a European trial showed superior outcomes for TULSA-PRO compared to traditional robotic prostatectomy [26] Q&A Session Summary Question: Update on the TACT trial - The TACT trial is nearing completion, with a few patients left to enroll, and three-year data shows continued improvement in side effects [34] Question: Install base expectations - There has been no dropout from the install base, and utilization continues to increase despite delays [39] Question: Impact of staffing shortages on procedure volumes - Staffing shortages have affected large hospitals, but the company has still seen significant growth in procedure volumes [41] Question: Capacity for installations in 2022 - The company has sufficient personnel to install devices rapidly, but hospital capacity remains a bottleneck [46] Question: Reimbursement timelines - The company plans to file for CPT-1 application next year, with all necessary clinical publications expected by the end of this year [50] Question: Trends in BPH versus cancer patients - The majority of patients treated are prostate cancer patients, with plans to broaden the scope for BPH applications in the future [92]