Third Quarter 2026 Earnings Call - TRISALUS LIFE SCIENCES INC

Explicit Guidance:

• FY2026 Revenue: Updated range of $46 million to $48 million, reflecting 2%–6% growth over FY2025; driven by slower-than-anticipated sales team ramp in expansion territories and a rapid shift toward super-selective Y90 administration which the new product line was not fully positioned to address until Q3.
• FY2026 Full-Year Outlook: Management anticipates a sequential step-up in revenue in Q4 2026, though exact figures are not provided in this call; confidence is based on continued expansion of the ordering account base and healthy revenue growth per account.
• FY2027 Outlook: Formal numerical guidance to be provided on the Q4 2026 earnings call; high-level expectations include a return to double-digit revenue growth driven by full-year productivity from the expanded sales team, a complete liver portfolio, and improved reimbursement.

Business-Segment Outlook:

• Product Launch (Trinav Advance): Following FDA clearance in September 2026, a limited market release is underway to gather early clinical and customer feedback; a broad launch is planned for 2027, specifically targeting the Q4 2026 pilot phase for data collection.
• Geographic Expansion: The "new expansion territories" (approx. 8 new sales reps) represent a slower growth segment compared to historical territories but show positive sequential volume growth; full productivity is expected to accelerate as new reps build relationships and integrate Trinav into workflows.
• Pipeline & Indications:
  • Liver Embolization: Addressing the full range of vessels via the complete liver portfolio (Trinav + Trinav Advance); focusing on HCC, liver metastases, and neuroendocrine tumors.
  • Non-Liver Indications:
    • Uterine Artery Embolization (UAE): Expanded retrospective study ongoing (50-patient target); prospective trial design phase to evaluate workflow reduction and outcome improvements.
    • Thyroid Artery Embolization (TAE): PROTECT registry reached interim analysis enrollment; first multicenter U.S. data expected in Q1 2027.
    • Pancreatic Artery Embolization: Pilot registry complete; formal clinical trial design phase; Nelotolimod consolidated periop data expected by end of 2026.

Market and Competitive Outlook:

• Market Size: U.S. addressable market for liver embolization with PEDD technology estimated at approximately $2.5 billion; company remains in early stages of capture.
• Competitive Landscape: Primary competitor is the standard microcatheter (commodity product); competitive strategy focuses on clinical efficacy (tumor response), safety, and economic value.
• Adoption Trends: Shift toward "super-selective" Y90 administration in small distal vessels (<2cm) accelerated faster than anticipated; this trend previously represented an access gap now fully addressable by Trinav Advance.
• Pricing Dynamics: Product is premium-priced; commercial focus is on demonstrating economic value to hospitals to overcome adoption friction.

Macro / Industry Outlook:

• Reimbursement (CMS CY2027 Final Rules):
  • Hospital Outpatient: HCPCS code C8004 (Y90 simulation) reassigned to APC 5194; payment expected to rise from ~$11,874 (2026) to ~$20,910 (Jan 1, 2027), an ~76% increase.
  • Physician Office/ABL: G-code G0577 established at national rate of ~$13,788 per procedure (up from ~$12,300 proposed), effective Jan 1, 2027; removes variability from contractor pricing.
• Site of Care Migration: Continued trend of treatment migrating from traditional hospital settings to Office-Based Labs (OBLs); new national G-code pricing expected to significantly expand access and flexibility for clinicians.
• Economic Environment: Management notes increasing scrutiny on procedure costs by hospitals and payers, reinforcing the need for HEOR evidence to prove cost-efficiency (e.g., ~$7,700 average cost reduction per patient identified in HEOR study).

Strategic Initiatives:

• Clinical Evidence Generation:
  • Neuroendocrine Tumor Study: Multicenter randomized trial vs. standard microcatheter launching by year-end 2026.
  • HCC Study: Two retrospective studies underway; prospective comparative study design informed by results; initiation expected by year-end 2026.
  • Liver Metastases: Stanford randomized pressure study ongoing (tumor-absorbed dose, response rate).
  • Safety Data: Reportable safety event rate of 0.02% across ~20,000 device uses since 2020.
• Commercial Expansion: Sales force more than doubled in H1 2026; focus on converting procedures and improving productivity in new territories.
• Cost Discipline: Continued management of operating expenses to position the business for lower cash burn in 2027.
• Safety & Value Validation: Initiatives structured around three questions: performance superiority, patient selection criteria, and economic value; aim to support inclusion in treatment guidelines over time.

Risks and Headwinds to Outlook:

• Commercial Ramp: Productivity of the newly expanded sales team is ramping slower than anticipated in new territories, impacting FY2026 revenue growth.
• Market Mix Shifts: A faster-than-expected shift toward super-selective Y90 administration in small distal vessels created a temporary revenue gap prior to the Trinav Advance launch.
• Adoption Friction: Product premium pricing requires continuous economic validation to drive hospital adoption.
• Regulatory/Reimbursement: While current CMS rules are favorable, the impact of future payment models remains an uncertainty to be monitored.
• Clinical Trial Execution: Timing of study completions (PETR publication, retrospective HCC analyses) and potential delays in prospective trial enrollment (e.g., PREDICT, expected 12–18 months).

Management Tone on the Future:

• Confidence Level: High optimism regarding 2027 growth drivers ("more growth drivers... than at any point in our history") despite current FY2026 headwinds.
• Strategic Sentiment: Management views the FY2026 revenue miss as a result of "the right decision" for long-term growth (sales expansion) rather than a fundamental market issue.
• Trend Assessment: Positive trend lines observed in expansion territories and sequencing of revenue growth in Q3; Q4 expected to show a sequential step-up.
• Guidance Philosophy: Prudent approach to guidance; avoiding over-promising while signaling confidence in "accelerating very meaningful double-digit growth" for 2027.

Miscellaneous:

• Financial Position: Ended Q3 2026 with ~$41 million in cash, deemed sufficient to fund the strategic growth plan through the launch and ramp of new initiatives.
• Safety Record: 0.02% reportable safety event rate serves as a key validation of product consistency.
• Q&A Specifics: Clarification provided that super-selective procedures (<2cm tumors) represent a small portion of the overall HCC market but are the specific niche addressed by Trinav Advance, which now allows full market coverage.