Company Overview - ESSA Pharma is focused on developing novel therapies for prostate and other androgen-driven cancers[7] - The company's lead candidate, EPI-7386, is a first-in-class oral, small molecule androgen receptor N-terminal domain inhibitor ("Aniten")[9, 28] - As of March 31, 2023, ESSA had $157 million in cash and short-term deposits, providing a runway through 2025[9, 69] EPI-7386 Monotherapy Development - Phase 1a study showed EPI-7386 was safe and well-tolerated, with tumor volume decreases observed in some patients[38] - ctDNA declines were observed in patients with AR mutations, amplifications, and truncations, suggesting activity against these tumors[38] - Phase 1b expansion study is underway to verify the recommended Phase 2 dose and gain further insight into EPI-7386's biological activity[40, 41] EPI-7386 Combination Therapy Development - ESSA is collaborating with multiple companies to evaluate EPI-7386 in combination with second-generation antiandrogens like enzalutamide, apalutamide, and darolutamide[49] - Initial data from the Phase 1/2 EPI-7386 + enzalutamide combination study showed rapid, deep, and durable PSA reductions[58] - In the combination study, 5 out of 6 patients achieved a PSA90, and 4 out of 6 patients achieved a PSA90 in 90 days and ultimately achieved a PSA < 02 ng/mL[58] Market and Opportunity - Prostate cancer is the 2nd most common cause of male cancer deaths, with an estimated 268,000 new cases and 34,500 deaths in 2022 in America[19] - Global sales of leading antiandrogens generated over $86 billion in 2021[19]

Investor Event © 2024 PROCEPT BioRobotics Corporation. All Rights Reserved. Safe Harbor Statement This presentation and accompanying oral presentation contain "forw ard-looking statements" w ithin the meaning of the Private Securities Litigation Reform Act of 1995, including the ex pected financial results of PROCEPT BioRobotics Corporation (the "Company"). W ords such as "anticipates," "believes," "ex pects," "intends," "projects," "anticipates," and "f uture" or similar ex pressions are intended to identi ...

Medicus Pharma Ltd. to Present at 2025 Bio International ConventionCompany Executive Chairman & CEO to Provide Corporate Updates on June 17th 2025June 12, 2025 7:30 AM EDT | Source: Medicus Pharma Ltd.Philadelphia, Pennsylvania--(Newsfile Corp. - June 12, 2025) - Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company") is pleased to announce the schedule of the presentation of Dr. Raza Bokhari, Executive Chairman and CEO, at 2025 Bio International Convention.Event DetailsDate: Tuesday, ...

ORION CORPORATION PRESS RELEASE 3 JUNE 2025 at 23.30 EEST U.S. FDA approves third indication of darolutamide for patients with advanced prostate cancer Darolutamide is the first and only in the U.S. and FDA-approved androgen receptor inhibitor (ARi) for the treatment of patients with hormone-sensitive prostate cancer (mHSPC), in combination with androgen deprivation therapy (ADT), with or without chemotherapy.This third approval is based on positive results from the pivotal Phase III ARANOTE trial and bro ...

Shares of ORIC Pharmaceuticals (ORIC) surged more than 20% in the pre-market hours today after announcing potentially best-in-class preliminary efficacy and safety data from the ongoing early-stage study of its novel, once-daily candidate, ORIC-944, for prostate cancer. ORIC-944, in combination with AR inhibitors, J&J’s (JNJ) Erleada (apalutamide) and Bayer’s (BAYRY) Nubeqa (darolutamide), is being evaluated in the phase Ib study for treating patients with metastatic castration-resistant prostate cancer (mC ...

Financial Data and Key Metrics Changes - HIFU revenues for Q1 2025 were EUR 6.2 million, an increase of 6.8% compared to EUR 5.8 million in Q1 2024 [11][24] - Total worldwide revenue for Q1 2025 was EUR 13.6 million, a decrease of 9.1% from EUR 14.9 million in the same period in 2024 [12][25] - Gross profit for Q1 2025 was EUR 5.7 million, down from EUR 6.4 million in Q1 2024, with a gross profit margin of 42% compared to 42.8% year-over-year [25][26] - Net loss for Q1 2025 was EUR 7.1 million or EUR 0.19 per diluted share, compared to a net loss of EUR 4.5 million or EUR 0.12 per diluted share in the prior year [27] Business Line Data and Key Metrics Changes - The company placed nine Focal One systems in Q1 2025, a record for any first quarter, including six cash sales and three operating leases [4][6] - U.S. procedures grew approximately 4% over Q1 2024, despite longer review and approval times for Medicare Advantage patients [12][13] Market Data and Key Metrics Changes - Four cash sales of Focal One systems were completed outside the U.S. in Q1 2025, indicating growing international demand [11] - The company noted that over half of the National Comprehensive Cancer Network (NCCN) member institutions now have access to the Focal One platform [10] Company Strategy and Development Direction - The company aims to become the global leader in HIFU focal therapy, focusing on growing its core HIFU business and expanding clinical data support [4][6] - The launch of the new Focal One I robotic HIFU system is expected to enhance technological leadership and meet future needs of surgeons [22][31] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in the payer landscape, particularly with Medicare Advantage plans, but noted progress in appeals and approvals [35][38] - The company reiterated its 2025 revenue guidance, expecting HIFU revenue growth between 16% and 25% year-over-year, while non-core segments are projected to decline [30][41] Other Important Information - The company received CE Mark approval for the treatment of deep infiltrating endometriosis, marking a significant regulatory milestone [14][15] - A landmark remote transatlantic Focal One robotic HIFU procedure was successfully conducted, showcasing technological advancements [17][18] Q&A Session Summary Question: Changes in payer landscape and procedure approvals - Management noted that the trends are primarily relevant to Medicare Advantage Plan patients, with ongoing efforts to improve market access and reimbursement [35][36] Question: Continued challenges in Q2 and approval processes - Management confirmed that while there is a risk of denials, notable progress in appeals is being made, with a majority of appeals resulting in approvals [38][39] Question: HIFU sales growth guidance assumptions - The guidance incorporates expected procedure growth and assumes that payer challenges may recede in the second half of the year [40][41] Question: Marketing plans for endometriosis after CE Mark approval - The company is in a controlled market entry phase in CE Mark countries and is preparing for broader launch based on clinical data [44][46]

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.