Financial 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]

Profound Medical Corp. (NASDAQ:PROF) Q2 2021 Earnings Conference Call August 4, 2021 4:30 PM ET Company Participants Stephen Kilmer - Investor Relations Dr. Arun Menawat - Chief Executive Officer Aaron Davidson - Senior Vice President, Corporate Development Conference Call Participants Rahul Sarugaser - Raymond James Neil Chatterji - Cowen Anthony Petrone - Jefferies Frank Takkinen - Lake Street Capital Markets Ben Haynor - Alliance Global Partners Scott McAuley - Paradigm Capital Operator Good day and than ...

Financial Data and Key Metrics Changes - For Q1 2021, the company recorded revenue of $711,000, down 41% from $1.2 million in Q1 2020, marking the first revenue decline since Q1 2018 [11][15] - Total operating expenses increased by 47% to $6.8 million compared to approximately $2.1 million in Q1 2020 [13] - The company reported a net loss of $7.5 million or $0.37 per common share, compared to a net loss of $2.6 million or $0.21 per common share for the same period in 2020 [15] Business Line Data and Key Metrics Changes - The company is commercializing two main technologies: TULSA-PRO for prostate treatment and Sonalleve for uterine fibroids and palliative pain treatment [5][6] - TULSA-PRO sites have exceeded initial procedure targets, achieving an average run rate of 60 procedures per year, which is 50% higher than the initial estimate [20] Market Data and Key Metrics Changes - The U.S. market entry strategy for TULSA-PRO targets early adopters, independent imaging centers, and teaching hospitals, with agreements signed with top-tier hospitals across major markets [19][22] - The first quarter saw the best performance in terms of new TULSA-PRO system agreements signed, with expectations to go live in summer 2021 [23][26] Company Strategy and Development Direction - The company aims to regain momentum despite COVID-19 impacts, with a focus on increasing the installed base and procedure volumes [33][34] - The strategy includes pursuing a CPT-1 application to enhance reimbursement prospects, with plans to file by the end of 2022 [30][62] Management's Comments on Operating Environment and Future Outlook - Management remains cautious but optimistic about recovering Q1 revenue shortfalls throughout the remainder of 2021, citing positive trends in March and April [12][33] - The company is confident in the long-term adoption of TULSA-PRO, supported by agreements with leading hospitals and ongoing clinical studies [24][34] Other Important Information - The company has transitioned its presentation currency from Canadian dollars to U.S. dollars to streamline reporting [10] - Cash reserves as of March 31, 2021, were reported at $78.5 million [15] Q&A Session Summary Question: When do you expect the newly contracted sites to be operational? - Most sites are expected to be operational by the end of June or July, with some in Q4 [38] Question: How many systems will be installed in the initial 10 centers across Florida, Texas, and Pennsylvania? - Majority of systems will be in Florida, with at least half in that state and the rest in Texas and Pennsylvania [40] Question: What is the mix of procedures being performed? - Approximately 20% of patients treated are in the BPH category, with a variety of cancer stages being treated [41][42] Question: Can you provide visibility on the number of installations expected in Q2 and Q3? - The company expects to install at least one to two systems per month, aiming for a total of 75 installations by the end of the year [50] Question: What is the status of the C-Code and CPT-1 application? - The C-Code strategy is working well, with hospitals getting paid for procedures, and the CPT-1 application is expected to be filed in early 2022 [61][62]

Financial Data and Key Metrics Changes - For Q4 2020, the company recorded revenue of $2.9 million, a 36% increase year-over-year and a 29% increase sequentially from Q3 2020 [14] - Total operating expenses were $6.1 million, up 14% from approximately $5.3 million in Q4 2019 [15] - The net loss for Q4 2020 was $7.5 million or $0.38 per share, compared to a net loss of $3.9 million or $0.33 per share in Q4 2019 [19] Business Line Data and Key Metrics Changes - R&D expenses increased by 4% to $2.5 million, driven by higher spending on clinical trials and employee-related costs [16] - Selling and distribution expenses surged by 79% to approximately $1.7 million, reflecting increased investment in the commercialization of TULSA-PRO [18] Market Data and Key Metrics Changes - The company has successfully established TULSA-PRO in the U.S. market, with early adopters achieving an average run rate of 60 procedures per year, exceeding initial expectations by about 50% [25] - RadNet has begun treating patients using TULSA-PRO after initial COVID-19 related delays [26] Company Strategy and Development Direction - The company aims to build a high-quality U.S. installed base for TULSA-PRO, targeting early adopters, independent imaging centers, and opinion-leading teaching hospitals [23] - The company is focused on reimbursement strategies, having submitted an application for a healthcare common procedure coding system C code from CMS for TULSA-PRO [28] Management's Comments on Operating Environment and Future Outlook - Management remains cautious about near-term performance due to unpredictable COVID-19 impacts but is optimistic about long-term adoption goals for TULSA-PRO [32] - The company plans to launch Sonalleve in the U.S. later in 2021, following its humanitarian device exemption approval [9][32] Other Important Information - The company has changed its presentation currency from Canadian dollars to U.S. dollars to better reflect its operations [13] - As of December 31, 2020, the company had cash reserves of $83.9 million [19] Q&A Session Summary Question: Can you provide insights on the average installation cycle pre-COVID and its current status? - The average installation cycle is currently between 75 to 90 days, with expectations to reduce to 45 to 60 days in the long term [36] Question: Are all existing contracts installed, or are there more contracts being signed? - There are contracts signed that have not yet been installed, and new contracts are being signed this year [44] Question: What is the reimbursement level under the C code? - The reimbursement generally ranges from $11,000 to $12,500, depending on the type of institution [39] Question: What progress is being made in international markets, particularly Japan and Europe? - Japan is expected to be an important market, with new orders being received, while Europe is seeing increased interest and additional clinical trials [54][56] Question: How does the recent study on MRI for prostate cancer diagnosis impact TULSA-PRO adoption? - The study indicates a potential increase in MRI use for diagnosis, which could positively influence TULSA-PRO adoption [58] Question: What are the expectations for installations and utilization moving forward? - The company has a strong pipeline and anticipates continued growth in installations and utilization, with a target of over 100 procedures in the long term [66][68]

Financial Data and Key Metrics Changes - For Q3 2020, the company recorded revenue of $3 million, an increase of 337% from $682,000 in Q3 2019 [8] - The net loss for Q3 2020 was $8.1 million or $0.43 per common share, compared to a net loss of $6.3 million or $0.57 per common share in the same period of 2019 [10] - Research and development expenditures increased by $1.3 million compared to Q3 2019, attributed to higher spending on materials and R&D projects [9] Business Line Data and Key Metrics Changes - The company is focusing on the commercialization of TULSA-PRO and Sonalleve globally, with net proceeds from a recent offering expected to fund these efforts [11] - The management team has been strengthened with new hires in marketing and market access, aimed at enhancing patient recruitment and reimbursement strategies [15][16] Market Data and Key Metrics Changes - The U.S. market entry strategy includes traction among early adopters, independent imaging centers, and opinion-leading teaching hospitals [17] - The Mayo Clinic and University of Texas Southwestern Medical Center are now offering the TULSA procedure, indicating growing acceptance in top-tier hospitals [18] Company Strategy and Development Direction - The company aims to drive significant adoption of the TULSA procedure by bolstering its management team and clinical development programs [14] - A three-pronged approach is being taken to target early adopters, imaging centers, and teaching hospitals to enhance credibility and drive long-term growth [41] Management's Comments on Operating Environment and Future Outlook - Management expressed caution regarding the near-term adoption rate of the TULSA procedure due to COVID-19 uncertainties, but remains optimistic about Q3 performance [23] - The company plans to extend clinical trials to support additional studies and build a robust evidence base for TULSA [22] Other Important Information - The company had cash of $110.4 million as of September 30, 2020, providing a solid financial foundation for future growth [11] - The management is committed to increasing investments in R&D and sales and marketing over the next 12 to 18 months to support growth [59] Q&A Session Summary Question: Updates on reimbursement for TULSA procedure - Management indicated that newer hospitals are considering recommendations for reimbursement codes, but no specific updates on patient numbers were available [26] Question: Pipeline for new sites - Management suggested that it is possible to reach up to 10 sites by the end of the year, depending on COVID-19 conditions [28] Question: Average procedures per week per imaging center - The number of procedures in Q3 was higher than in Q2, with expectations of increased utilization per site [34] Question: Payment per procedure model - The company has shifted to a recurring revenue model, with agreements typically at $7,000 or higher per patient [37] Question: Long-term sales funnel and site interest - Management expressed confidence in the sales funnel, with interest from imaging centers, teaching hospitals, and specialized urologists [41] Question: R&D expense outlook - R&D expenses are expected to increase as the company invests in clinical trials and product improvements [47]

Profound Medical Corp. (NASDAQ:PROF) Q2 2020 Earnings Conference Call August 6, 2020 4:30 PM ET Company Participants Stephen Kilmer - Investor Relations Arun Menawat - Chief Executive Officer Aaron Davidson - Chief Financial Officer & Senior Vice President of Corporate Development Conference Call Participants Josh Jennings - Cowen Rahul Sarugaser - Raymond James Ben Haynor - Alliance Global Partners Operator Good day, ladies and gentlemen, and welcome to your Profound Medical Second Quarter 2020 Financial R ...

Financial Data and Key Metrics Changes - For Q1 2020, the company recorded revenue of $1.6 million, a 6% increase from $1.5 million in Q1 2019 [7] - The net loss for Q1 2020 was $3.6 million or $0.25 per share, compared to a net loss of $2.9 million or $0.27 per share in the same period of 2019 [10] - R&D expenditures increased by $161,000 due to heightened spending on R&D projects and additional systems applications [7] - General and administrative expenses rose by $1.5 million, attributed to salary increases, bonuses, and costs associated with being listed on NASDAQ [9] - As of March 31, 2020, the company had cash of $61.9 million after closing an underwritten offering of common shares that generated approximately $40 million in gross proceeds [12] Business Line Data and Key Metrics Changes - The company has initiated its first two TULSA commercial sites in the U.S., focusing on treating various prostate diseases [15] - Initial patient feedback has been positive, with reports of minimal pain and quick recovery times [17] - The company plans to tailor its support program to fit the needs of different delivery channels, including urologists and imaging centers [24] Market Data and Key Metrics Changes - The company anticipates delays in achieving its target of 20 TULSA sites by year-end due to the COVID-19 pandemic, potentially pushing timelines by one to two quarters [25] - The Busch Imaging Center in Georgia treated 8 patients within the first two weeks, indicating strong initial demand [44] Company Strategy and Development Direction - The company is focusing on three primary market segments: urologists, imaging centers, and Centers of Excellence at teaching hospitals [18][22] - The strategy includes partnering with leading physicians and imaging centers to create TULSA treatment centers [19] - The company is adapting its marketing efforts to target independent imaging centers and urologists during the pandemic [36] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism regarding the pipeline and noted that urologists are open to learning about new technologies during the pandemic [32] - The company is actively holding webinars and educational programs to maintain engagement with potential clients [32] - Management believes that patient preferences may shift towards imaging centers rather than hospitals due to COVID-19 concerns [39] Other Important Information - The company has submitted an application for a Health Care Common Procedure Coding System C-Code for the TULSA-PRO procedure, viewing reimbursement as a three-year process [27] - Management is exploring existing codes that could apply to TULSA, with the potential for hospitals to decide on their use [28] Q&A Session Summary Question: Update on TULSA-PRO sales funnel and COVID-19 impact - Management confirmed that the sales funnel continues to build, with urologists open to learning about new technology despite the pandemic [32][36] Question: Patient preferences for ablative treatments during COVID-19 - Management acknowledged that patients may prefer imaging centers over hospitals for treatments due to COVID-19 fears [39] Question: Details on existing reimbursement codes - Management indicated that hospitals are evaluating existing MR-guided interventional codes, but specific reimbursement amounts cannot be disclosed at this time [48][49]