Financial Data and Key Metrics Changes - For the three-month period ended June 30, 2023, the company recorded revenue of $1.6 million, an increase of 38% from $1.2 million in the same period of 2022 [9] - Total operating expenses in Q2 2023 were $7.5 million, a decrease of 14% compared to $8.7 million in Q2 2022 [10] - The net loss for Q2 2023 was $7.4 million, or $0.35 per common share, compared to a net loss of $5.9 million, or $0.28 per common share for the same period in 2022 [25] Business Line Data and Key Metrics Changes - U.S. recurring revenue grew by 21% in Q2 2023 compared to Q1 2023, and by 63% when comparing the first half of 2022 to the first half of 2023 [27] - The installed base of TULSA systems increased from 34 to 38 in Q2 2023, with expectations to reach 50 by the end of the year [16][59] Market Data and Key Metrics Changes - Approximately 66% of patients treated were for prostate cancer, 25% for hybrid conditions of cancer and BPH, 7% for salvage, and 2% for BPH only [31] - The total addressable market for TULSA is estimated at about 600,000 patients, larger than any other technology for treating prostate cancer [45] Company Strategy and Development Direction - The company aims to drive adoption of the TULSA procedure in the U.S. and has achieved the approval of Category 1 CPT codes for the TULSA procedure, effective January 1, 2025 [13][50] - The focus remains on increasing the installed base in the U.S. while also expanding in international markets, particularly Japan [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving U.S. revenue growth of about 70% over the previous year, driven by a recurring revenue model [27] - The company is optimistic about the impact of the new CPT codes on adoption rates and is seeing positive feedback from hospitals and physicians [61] Other Important Information - The company has a net cash position of $39.3 million as of June 30, 2023 [25] - The TACT Pivotal Study results demonstrated the predictability and durability of the TULSA procedure, with promising five-year outcomes [46] Q&A Session Summary Question: Can you provide an update on the growth of installed devices? - Management noted the need to grow by an average of six more devices per quarter to meet the year-end goal of 50 installations, with positive momentum expected due to the new CPT codes [51][61] Question: What is the status of reimbursement discussions? - Management indicated ongoing dialogue with CMS regarding the expansion of existing codes to ambulatory centers, with updates expected in early October [62] Question: How is the macro environment affecting system installs? - Management reported that the macro environment is not presenting significant headwinds, and the pipeline for installations remains strong [80] Question: What are the expectations for the CAPTAIN clinical trial? - Preliminary results from the CAPTAIN trial are expected in early 2025, focusing on head-to-head comparisons with radical prostatectomy [78] Question: Can you discuss the potential for ASCs? - Management sees ASCs as a prime target for TULSA adoption, emphasizing the advantages of outpatient procedures without incisions [110]
Profound(PROF) - 2023 Q2 - Earnings Call Transcript