Summary of Radiopharm Theranostics (RADX) Update / Briefing August 26, 2025 Company and Industry Overview - **Company**: Radiopharm Theranostics (RADX) - **Industry**: Oncology, specifically focusing on prostate cancer treatment and radiopharmaceutical therapies Key Points and Arguments 1. **Prostate Cancer Treatment Landscape**: The treatment of prostate cancer has evolved significantly, moving from traditional methods like surgery and chemotherapy to incorporating genetics, molecular imaging, and targeted therapies, including immunotherapy and radiopharmaceuticals [11][12][30] 2. **B7-H3 as a Target**: B7-H3 is highlighted as a promising new target for prostate cancer treatment, being highly expressed in various tumors, including 93% of castrate-resistant prostate cancer cases. This makes it a viable alternative to PSMA-targeted therapies, especially in cases where PSMA expression is low [39][41][43] 3. **Need for New Therapies**: There is a critical need for more effective therapies for metastatic castration-resistant prostate cancer, as current treatments often provide limited survival benefits [18][30] 4. **NCCN Guidelines**: The National Comprehensive Cancer Network (NCCN) guidelines are discussed, emphasizing the importance of treatment sequencing and the variety of options available based on prior therapies [19][20] 5. **Theranostics Concept**: The concept of theranostics is introduced, where ligands are designed to bind to specific cancer cell targets, allowing for both diagnosis and treatment using radiopharmaceuticals [24][25] 6. **Clinical Trials and FDA Approvals**: The presentation mentions several clinical trials demonstrating survival benefits from new therapies, including the FDA approval of Plavicto (lutetium-177) for prostate cancer treatment [27][28][51] 7. **BetaBART Development**: The development of BetaBART, a humanized monoclonal antibody targeting the four Ig isoform of B7-H3, is presented as a novel approach in radioimmunotherapy, with plans for a Phase 1 trial in 2025 [51][66] 8. **Competitive Landscape**: The competitive landscape for B7-H3 targeting is discussed, noting that while there are other modalities like ADCs and CAR T-cell therapies, the unique properties of BetaBART provide a competitive advantage [75][78][87] 9. **Immunological Memory**: Evidence of secondary immune memory from prior treatments suggests that BetaBART may not only target tumors but also enhance the immune response against them [64][66] 10. **Market Potential**: The potential market for B7-H3 targeting therapies is significant, with opportunities extending beyond prostate cancer to other solid tumors [46][51] Other Important but Overlooked Content 1. **Challenges with Current Therapies**: The limitations of existing therapies, including the need for better options post-Plavicto treatment, are emphasized, highlighting the urgency for innovation in this space [30][102] 2. **Mechanism of Action**: The mechanism of action for BetaBART is discussed, focusing on its ability to selectively target the four Ig isoform of B7-H3 while minimizing off-target effects and toxicity [49][66] 3. **Future Directions**: The discussion includes the need for randomized control groups in future trials to better assess the efficacy of new treatments [31] This summary encapsulates the critical insights from the briefing, focusing on the advancements in prostate cancer treatment, the significance of B7-H3 as a target, and the innovative approaches being developed by Radiopharm Theranostics.

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $79.2 million, representing a growth of 48% compared to Q2 2024 [21] - U.S. revenue for Q2 was $69.6 million, reflecting a growth of 46% year-over-year [21] - Gross margin for Q2 2025 was 65.4%, an increase of 640 basis points year-over-year [25] - Net loss for Q2 2025 was $19.6 million, compared to a net loss of $25.6 million in Q2 2024 [26] - Adjusted EBITDA loss was $8 million, an improvement from a loss of $18 million in the prior year [26] Business Line Data and Key Metrics Changes - U.S. handpiece and consumable revenue for Q2 2025 was $43.1 million, a growth of 58% compared to Q2 2024 [21] - Approximately 12,750 handpieces were sold in Q2 2025, representing a year-over-year unit growth of 59% [22] - U.S. system revenue was $22.1 million, with 48 new HydroS robotic systems sold [23] - International revenue reached $9.6 million, marking a growth of 69% compared to the prior year [24] Market Data and Key Metrics Changes - The company expects to exit 2025 with an estimated installed base of 715 systems, with only 20% procedural share in the hospital market, indicating significant room for expansion [4] - The 2026 proposed Medicare physician fee schedule includes a category one code for Ag population therapy, which is expected to enhance adoption and reimbursement consistency [14][15] Company Strategy and Development Direction - The company aims to become a global leader in urology, focusing on evidence-based innovation and expanding Hydro's adoption in greenfield accounts [10][34] - A leadership transition is underway, with Larry Wood set to become the new CEO, emphasizing a commitment to innovation and growth [10][36] - The company is eliminating the role of Chief Commercial Officer to strengthen commercial execution, creating two new leadership positions [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to achieve long-term profitability despite current tariff challenges, estimating a potential gross margin headwind of $1 million to $2 million in 2025 [31][92] - The company remains optimistic about the stability of the capital environment, with no indications of hospitals slowing or pausing capital spending [91] - Management highlighted the importance of clinical outcomes in driving adoption and utilization of their systems, despite recent reductions in physician fee schedules [60] Other Important Information - The company is actively pursuing operational strategies to mitigate tariff exposure, with a focus on maintaining gross margins and profitability [16][31] - Enrollment in the WATERFORT trial is progressing well, with expectations for full enrollment by 2026 [17] Q&A Session Summary Question: Guidance confidence and system placements - Management confirmed slight increases in guidance, with confidence stemming from strong sales force execution and visibility into the sales funnel [41][46] Question: Disruption from leadership changes - Management reassured that the experienced sales team will maintain focus and execution despite leadership transitions [48][49] Question: CCO role split rationale - The decision to split the CCO role aims to enhance commercial execution and support long-term growth objectives [52] Question: Utilization growth in accounts - Management noted that longer tenure in accounts correlates with increased utilization of aquablation procedures, with examples of it becoming the standard of care [55] Question: Impact of physician fee schedule reductions - Management emphasized that clinical outcomes will drive continued adoption, despite reductions in resective procedure payments [60] Question: System placements and future expectations - Management indicated that replacement sales are expected to pick up in 2026, aligning with the useful life of the systems [62] Question: International market strength - The UK remains the primary driver of international revenue growth, with emerging progress in Japan and Korea [68] Question: Hydros rollout and customer reception - Early feedback on the Hydros system has been positive, with expectations for utilization metrics to improve as accounts ramp up [75]

Financial Performance & Guidance - PROCEPT BioRobotics reported Q1 2024 global revenue of $445 million, an 83% year-over-year increase [22] - International revenue in Q1 2024 reached $43 million, a 65% year-over-year increase [22] - The U S installed base grew to 354 systems, an 84% year-over-year increase [22] - U S handpiece sales reached 6800, a 100% year-over-year increase [22] - The company projects total revenue for 2024 to be approximately $2135 million, representing a 57% year-over-year growth [26] - The company anticipates a gross margin of approximately 58% to 59% for 2024 [26] - Adjusted EBITDA loss is projected to be approximately $70 million for 2024 [26] - As of March 31, 2024, the company had a total cash and cash equivalents balance of $226 million and a debt balance of $52 million [27] Commercial Strategy & Market Expansion - The company aims to convert all resective BPH hospital-based procedures to Aquablation Therapy [39] - The company reports that over 95% of U S covered lives are now under signed majority IDN contracts [43] - Aquablation Therapy cases at Georgia Urology have increased 95x since 2019 [67] Prostate Cancer Research & Development - Approximately 1/3 of men with BPH also have prostate cancer, representing 300000 diagnoses per year [89] - Initial Aquablation impressions for prostate cancer show promise, with real-time imaging and surgeon confidence [113, 114] - Early results from a study (n=5) show 0% incontinence and 0% erectile dysfunction, as well as 0% actionable disease and 0% residual tumor on MRI [138, 148]

Core Viewpoint - ORIC Pharmaceuticals' shares increased over 20% in pre-market trading following the announcement of promising preliminary efficacy and safety data for its prostate cancer treatment candidate, ORIC-944 [1] Group 1: Study Results - ORIC-944 is being evaluated in a phase Ib study in combination with J&J's Erleada and Bayer's Nubeqa for treating metastatic castration-resistant prostate cancer (mCRPC) [2] - The study reported that 59% of the 17 previously-treated mCRPC patients showed a 50% drop in PSA levels (PSA50 response), with a confirmed PSA50 rate of 47% [4] - Additionally, 24% of patients demonstrated a 90% drop in PSA levels (PSA90 response), all of which were confirmed [4] - PSA responses were consistent across all dosage levels and combinations with either Erleada or Nubeqa, indicating a well-tolerated safety profile with mild to moderate adverse events [6] Group 2: Future Plans - ORIC Pharmaceuticals aims to complete the phase Ib dose exploration by mid-2025 and plans to test two potential recommended phase II doses in the second half of 2025 [7] - The results from the dose optimization phase will inform the best ORIC-944 dose for the first global phase III study, expected to start in the first half of 2026 [8] Group 3: Financial Aspects - ORIC Pharmaceuticals announced a $125 million private placement to fund operations through the second half of 2027, covering expenses until the primary endpoint data readout from the phase III mCRPC study [9]

Summary of PROCEPT BioRobotics (PRCT) Q1 2025 Conference Call Company Overview - **Company**: PROCEPT BioRobotics (PRCT) - **Industry**: Medical Technology Key Points Q1 Performance and Guidance - Q1 procedures exceeded expectations with 11,200 cases completed, surpassing the guidance of 10,700, representing a year-over-year increase of approximately 4.5% [4][5] - The company maintained its full-year guidance despite the strong Q1 performance, reflecting a conservative approach due to market conditions [5][12] - Monthly procedure growth showed improvement: February was better than January, and March was better than February [3] Capital Expenditure (CapEx) and Systems Sales - Q1 systems sales met expectations, with the average selling price at the high end of guidance [11] - The company noted that Q1 is typically challenging for capital equipment sales due to unvetted hospital budgets, but they are optimistic about the sales funnel for the remainder of the year [10] Utilization and Procedures - Utilization in Q1 was reported at 7.1%, with a 5% growth [15] - The company did not provide specific quarterly guidance for procedures but expressed confidence in meeting market expectations for Q2 and Q3 [18] - The company tracks metrics such as active surgeons and utilization rates, indicating positive trends in surgeon engagement and case volume [20][22] Tariffs and Gross Margin Impact - The company faced a tariff impact of approximately $5 million on gross margins due to a 145% import tariff on key components from China, which has since been reduced to 30% [30][31] - The anticipated impact on gross margins is now estimated to be between $1 million to $2 million, significantly less than previously communicated [31] Reimbursement and CPT Code Change - The transition from a Category 3 to a Category 1 CPT code is expected to occur in summer 2025, with no significant changes anticipated in reimbursement rates compared to other resective procedures [33][40] - The company expects to remain competitive in reimbursement rates, aligning with existing procedures in the market [39] Prostate Cancer Opportunity - The company is exploring opportunities in prostate cancer treatment, with a focus on minimizing side effects such as incontinence and erectile dysfunction [42] - Initial studies have shown promising results, and the company is optimistic about the potential market size, estimating significant revenue growth from prostate cancer procedures by 2028 [49][51] Financial Outlook - The company is on track to potentially achieve EBITDA breakeven by Q4 2025, although this is not the primary focus as they prioritize growth investments [55][57] - Gross margin expansion is expected to continue, driven by leveraging fixed costs as the business scales [58][59] Additional Insights - The management emphasizes a long-term growth strategy, focusing on maintaining a balance between investment in growth and achieving profitability [57] - The company has a robust cash position of $300 million, providing a strong foundation for future growth initiatives [57] This summary encapsulates the key insights and data points from the PROCEPT BioRobotics Q1 2025 conference call, highlighting the company's performance, strategic outlook, and market opportunities.