Arun Menawat
Analyst · Raymond James. Please go ahead
Thank you, Rashed. And good afternoon, everyone. At the beginning of the year, we identify certain goals that we want to achieve this year to achieve our main objective of driving adoption of the TULSA procedure for patients with prostate diseases in the United States. At this mid-year point, I would like to start by discussing where we are against these goals. First and foremost, we indicated that we anticipated that the growth of the TULSA procedures in the United States would kick up to about 5% per month in 2023. By failing it as a monthly basis, part of our intention was to highlight the predictability of our recurring revenue business model. As compared to Q1 2023, the U.S. recurring revenue grew by 21% in Q2 2023. Comparing the first half of 2022 versus the first half of 2023, the U.S. recurring revenue grew by 63%. Based upon these results, we remain comfortable that our U.S. business will continue to grow at a similar or better pace in the second half of this year delivering U.S. revenue growth of about 70% over last year. We realize that these numbers have a small base but our benchmarks indicate that acceleration of the growth rate in the upper double digit is the right expectation at this stage of the company where the primary mode of payment remains cash pay. 70% of our patients today remain cash share patients and are typically paying over $30,000 per procedure. The second expectation was that we would apply and receive approval of Category 1 CPT codes specifically for the TULSA procedure and as you already know, that goal was achieved in June. With sponsorship and support from multiple physician specialty society, the AMA established three new Category 1 codes for TULSA, which will be effective on January 1, 2025. The first code is for a procedure performed by a specialist such as a urologist without assistance from another specialist. The other two codes are for a procedure performed by two physician, such as a urologist and a radiologist. We believe having multiple codes gives our physician users the flexibility to either do the whole procedure or collaborate and get reimbursed for their part of the service. The next step of the CPT application process involves the relative value scale update committee, or RUC sending questionnaires to TULSA users to determine the physician work related value units or RUVs associated with the TULSA procedure. Both the SIR and the AUA will be very involved in this process, which along with reviewers by the center of Medicare and Medicaid Services, or CMS will ultimately determine the TULSA procedure payment amount. For reference, the U.S. hospitals performing the TULSA procedure on Medicare patients are currently utilizing HCPCS code C9734 established by the U.S. centers for Hospitals Outpatient Prospective Payment System and reimbursement to a hospital billing under this code is $13,048. The proposed recommendations are expected to be published in the Federal Register in August 2024 finalized in October 2024 and come into effect as of January 2025. The third goal was about increasing the size of the installing given that our U.S. business model is about getting paid on a per patient basis in larger install base in preparation of January 25 when the Category 1 CPT code will become effective will be important to drive faster growth in the future. Today, we have an installed base of 38 system, an additional 7 contracts to be installed and a pipeline in the final stages of 15 additional installation. All together this gives us confidence that we will be expected install base of 50 systems by the end of this year. Indeed, none of the U.S. business objectives or deliverables for the remainder of 2022 have changed. The non-U.S. business however is all about capital revenue, which is always unpredictable in the early stages and is even more so, in our case, since we have chosen to increase our sales and marketing investments in the U.S. and not in the international market. Having said that, we do expect that our install base in certain country, including the important market of Japan will increase in the second half of 2023. Turning to our utilization metric. Over the last two quarters, I have talked about the variety of patients that are being treated using TULSA technology. We continue to see that more and more sites are increasing the variety of TULSA patient they are achieving. With respect to indication, approximately 66% were treated for prostate cancer, 25% or hybrid patient suffering from both cancer and BPH, 7% are salvage and 2% for men with BPH only. TULSA is increasingly being used in patients who are on active surveillance or diagnosed with low grade cancer but also have symptoms of BPH. We to see TULSA as the only minimally invasive option for such patients. For cancer grade, approximately 14% was Grade Group 1, 60% was Grade Group 2, 17% was Grade Group 3, and 9% was Grade Group 4 and Grade Group 5. In terms of abrasion, around 60% were whole gland, 24% was greater than 50% but less than 100% and 16% was focal therapy. For prostate size, approximately 4% or less than 20 cc, 34% were between 20 cc to 40 cc, 37%, were between 40 cc to 60 cc, 20% are between 60 to 100 cc, and 5% were over 100 cc. Based upon these results clearly TULSA continues to be used in a wide variety of patients with prostate disease and we continue to believe that the total addressable market for TULSA is about 600,000 patient which is larger than that of any other technology that can be used to treat patients with prostate cancer. Finally, I would like to provide an update on the TACT Pivotal Study, which has reached the end of five year follow up duration and the results demonstrate the predictability and durability of the TULSA procedure. By five years, median prostate specific antigen or PSA was 0.63 nanograms per milliliter and only 21% of patients received additional treatment for prostate cancer without unexpected complications. The letter outcome is especially compelling as it falls in line with the one year biopsy data and compares well with similar rates reported after radical prostatectomy intermediate with men in several publications including the pivot randomized controlled trial and the capture registry, one of the largest databases of prostate cancer in the United States. Although this outcome was achieved despite the fact that a second TULSA ablation was not permitted by protocol. Since the early days of TACT, physician experience and protocols for patient selection and treatment have been refined, and on review, the risk of failure is mitigated by modern management approaches. Additionally, we have been able to demonstrate that data from intraprocedural thermal MRI imaging and our early clinical follow-up can indeed predict the risk of salvage therapy by five years. The five year outcomes in the TACT study also establish the durability of the favorable safety and functional outcomes that were achieved by one year. For urinary continence 92% of patients who were pad-free before TULSA remain so at five years stable from one year. This is consistent with natural decline in function typically observed in men of this age over this time period, as reported, for example in the observation arm of a pivot randomized controlled trial. For erection function, zero men experienced grade 3 severe erectile dysfunction where medication is not helpful and 87% of men preserved baseline erection sufficient for penetration by the five year visit. There were no attributable Grade 3 severe or serious adverse events reported from two to five years. To summarize, most of the boxes for increased adoption of TULSA-PRO has now been checked. Our reporting of preliminary five year results from the TACT file comes within the context of increased awareness of the high incontinence and erectile dysfunction, side effect rates with radical prostatectomy and radiation treatment. The preliminary five year TACT data demonstrates that one year safety, efficacy, functionality and salvage therapy risks outcomes are predictive of the same outcomes at five years. This is encouraging, as we expect in Q1 2025 initial data from our ongoing level 1 CAPTAIN clinical trial. TULSA continues to the unrivalled in the types and numbers of prostrate disease patients that urologist are using to treat prostate disease safely and effectively. With 38 TULSA-PRO comprised of top tier hospitals, independent corporate centers and opinion leading practices, we now have a large number of experienced physicians, especially urologist who are ready to lead adoption of TULSA-PRO. We remain on track to grow our install base to 50 TULSA-PRO sites by the end of 2023 and at least 75 by the end of 2024. TULSA-PRO offers a price point of over $8,000 per patient. Our recurring revenue has grown for five consecutive quarters and we expect that to continue going forward. Our recurring revenue model already yields high gross margin of around 55% and we think they will potentially exceed 75% in future with increased volume. We are delighted with the AMA's establishment of three new CPT Category 1 codes for TULSA which will be effective on January 1, 2025 and look forward to the next stage of the CPT process. Finally, we continue to believe that the establishment of the permanent reimbursement codes combined with the initial data from the CAPTAIN clinical file will serve as a significant catalyst for TULSA adoption in the U.S. beginning in the first quarter of 2025. This ends our prepared remarks for today. With that, Rashed and I are happy to take any questions you might have. Operator?