Financial Performance & Capital Raising - Pacific Edge reported a net loss after tax of $29.9 million, a 1.4% increase compared to FY24[22] - Operating revenue decreased by 8.6% to $21.8 million compared to FY24[22] - Commercial tests decreased by 9.9% to 24,642 compared to FY24[22] - Global tests decreased by 11.5% to 28,894 compared to FY24[22] - The company raised $20.735 million in new equity through a Placement of $16.073 million and a Share Purchase Plan (SPP) of $4.662 million[28] Medicare & Reimbursement - Medicare non-coverage in April 2025 impacted US volumes and revenue, with Medicare previously accounting for approximately 61% of revenue in FY25[21, 46] - A draft price for Triage Plus of US$1,018 per test was published by CMS, which could improve unit economics if Medicare coverage is re-established[26, 75, 77] - The company is seeking re-coverage via LCD reconsideration and Medicare appeals, with positive engagement with Novitas to restore coverage for Triage and Monitor[47] Clinical & Commercial Strategy - Cxbladder Triage was included in the American Urological Association (AUA) Microhematuria guideline, providing clinical validation and driving commercial payer opportunities[26, 35] - US commercial volumes in 2H 25 increased 2.7% against 1H 25, supported by contracted payer volumes[61] - Non-Medicare volumes represented 47% of US commercial volumes (~9,366) in FY 25, compared to 40% (~5,358) in 1H 24[61] - The company is investing in innovation and product development for IVD kits to support entry into international markets[29]

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $13.6 million, a 15% increase compared to the same quarter last year [5][18] - U.S. heart failure revenue was $12.2 million, also a 15% increase year-over-year [19] - Gross profit increased to $11.5 million, a 16% increase from the prior year [21] - Net loss for the quarter was $14.7 million, or $0.57 per share, compared to a net loss of $14 million, or $0.65 per share, in the prior year [23][24] Business Line Data and Key Metrics Changes - Heart failure revenue units in the U.S. increased to 3.87 million from 3.39 million year-over-year [19] - The number of active implanting centers in the U.S. rose to 240 from 227 at the end of Q1 2025 [6][20] - The number of sales territories in the U.S. increased to 47 from 45 at the end of Q1 2025 [6][20] - Revenue in Europe was $1.3 million, a 19% increase year-over-year, although total revenue units in Europe decreased to 61 from 63 [21] Market Data and Key Metrics Changes - The company expanded its U.S. sales territories and active implanting centers, indicating growth in market presence [6][20] - The reimbursement strategy is advancing, with CMS proposing to maintain the Barostim implant procedure payment at approximately $45,000 [12][13] Company Strategy and Development Direction - The company is focusing on sustainable Barostim programs and optimizing onboarding and training for new territory managers [8][11] - The strategy includes targeting Tier one and Tier two accounts while also exploring opportunities in Tier three and four accounts [10][11] - The company is committed to building clinical evidence and increasing awareness of Barostim through educational programs [15][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the direction of the business and the momentum being built, particularly in sales force stabilization and reimbursement improvements [26] - The company anticipates continued growth driven by strong fundamentals and a predictable therapy [26] - Management acknowledged ongoing challenges in changing medical practices but believes reimbursement improvements will significantly reduce friction [84][85] Other Important Information - The company appointed Brent Binkowski as Chief Operating Officer, effective August, to oversee research and development, operations, regulatory affairs, and quality [27] - The company narrowed its revenue guidance for the full year of 2025 to between $55 million and $57 million [25] Q&A Session Summary Question: Can you walk us through the narrowed guidance and how it contemplates the ramp of new territory managers? - Management explained that the narrowed guidance reflects a slight adjustment and focuses on getting the new team productive as quickly as possible [30] Question: How do you measure the success of Tier three and four accounts? - Management clarified that they track data internally and provide it to reps as part of their playbook, helping them understand which accounts may be more receptive [32] Question: What are the expectations for the Salesforce reorganization and productivity ramp? - Management indicated that they expect to activate more territories and see productivity ramp up as new reps become more effective [38] Question: What are the implications of the gross margin guidance? - Management stated that the gross margin has been consistent and they expect to maintain similar numbers in Q3 and Q4 [42] Question: Can you elaborate on the reimbursement process and the transition to a category one code? - Management explained that the transition to a category one code will improve approval rates and predictability for procedures, moving away from the experimental status of category three [56][58] Question: What are the expected challenges for next year regarding adoption? - Management identified ongoing barriers related to reimbursement, awareness, and evidence generation as challenges that will persist [85]