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    TLSI
    Earnings call· Jun 2026(Q2 FY26)

    TriSalus Life Sciences Q2 FY26 earnings call TLSI

    Aug 6, 2026 Source

    Executive summary

    TriSalus Life Sciences Q2 FY26 — Strong Revenue Growth and Expanded Reimbursement

    TriSalus delivered a strong second quarter, driven by commercial expansion and progress in clinical evidence generation for its TriNav system. The company secured a significant G-code from CMS, expanding reimbursement into office-based labs, which is expected to accelerate adoption across liver and non-liver indications. While investments in commercial infrastructure led to increased losses, management reiterated full-year revenue guidance, expressing confidence in future growth and disciplined cost control.

    Highlights

    4

    • Total revenue exceeded $11.4 million, reflecting sequential and year-over-year growth.

    • Gross margin improved to 86.8% in Q2 FY26, up from 83.9% in the prior year period.

    • CMS issued a G-code in July, extending TriNav system reimbursement into physician office settings (OBLs), significantly expanding market access.

    • Full-year 2026 revenue guidance was reiterated at $54 million to $57 million, representing 19% to 26% growth over full year 2025.

    Concerns

    3

    • Adjusted EBITDA loss increased to $7.1 million in Q2 FY26, compared to $5.3 million in Q2 FY25, due to investments in commercial expansion.

    • TriNav Advance 510(k) clearance is running past the MDUFA goal, though the company remains in close dialogue with the FDA.

    • Sales and marketing expenses rose to $11.4 million in Q2 FY26 from $7.2 million in Q2 FY25, reflecting deliberate investment in commercial footprint expansion.

    Guidance & targets

    9
    CategoryTargetConfidence
    Full-year revenue
    $54 million to $57 million
    high materiality
    High
    Growth trajectory
    Sequential improvement in growth from Q2 to Q3, followed by a stronger Q4
    medium materiality
    High
    Sales and marketing expenses
    Decline sequentially in the third and fourth quarter
    medium materiality
    High
    Nelitolimod PERIO Phase I data readout
    Consolidated data readout
    medium materiality
    High
    PROTECT registry (TAE) data delivery
    First multicenter U.S. data
    medium materiality
    High
    PREDICTT study enrollment completion
    Approximately 12 to 18 months to complete
    low materiality
    Medium
    PRESSURE study open enrollment
    Launch open enrollment
    low materiality
    High
    PAIR study kick-off
    Kick off
    low materiality
    High
    TACE study in neuroendocrine tumors kick-off
    Kick off
    low materiality
    High

    Operational metrics

    11
    Gross margin
    86.8%vs 83.9% in Q2 FY25
    Q2 FY26

    Improvement driven by efficiency gains.

    Research and development expenses
    $3.1 millionvs $3.7 million in Q2 FY25
    Q2 FY26

    Decrease primarily due to reduced costs associated with the nelitolimod program.

    Sales and marketing expenses
    $11.4 millionvs $7.2 million in Q2 FY25
    Q2 FY26

    Increase reflects strategic investment in commercial infrastructure.

    General and administrative expenses
    $5.1 millionvs $5.9 million in Q2 FY25
    Q2 FY26

    Decrease primarily due to reduced professional service costs.

    Adjusted EBITDA loss
    $7.1 millionvs $5.3 million in Q2 FY25
    Q2 FY26

    Increased loss reflects investment in commercial infrastructure for long-term growth.

    Cash balance
    $46.3 million
    end of Q2 FY26

    Cash position at the end of the quarter.

    Addressable market
    $2.5 billion
    future

    Estimated total addressable market for the PEDD platform.

    Average cost savings per procedure with PEDD
    $7,700
    certain procedures

    HEOR data demonstrating economic benefits of TriNav.

    Commercial footprint expansion
    more than doubled
    H1 FY26

    Significant expansion of the sales organization.

    Active clinical studies
    11
    Q2 FY26

    Number of ongoing clinical studies for the PEDD platform.

    Patients treated with TriNav (data generated/evaluated)
    >400
    cumulative

    Total number of patients treated with TriNav across active studies.

    Industry KPIs

    6
    MetricValueDetails
    Launch access metricsG-code for TriNav system
    Pipeline read out calendar11studies
    Product franchise net sales$11.4 millionUSD
    Regulatory approvals filingsG-code for TriNav system
    Clinical trial efficacy safety dataMeaningful improvements in progression-free survival
    Cumulative patients uptake since launch>400patients

    Product announcements

    1
    ProductTypeDetails
    TriNav Advanceupdate

    Risks & headwinds

    3
    TriNav Advance 510(k) clearance delayNear term

    Review is running past the MDUFA goal.

    Mitigation: Remaining in close dialogue with the FDA and hoping to receive clearance in the near future.

    Increased Adjusted EBITDA lossQ2 FY26

    $7.1 million loss in Q2 FY26 compared to $5.3 million in Q2 FY25.

    Mitigation: This reflects deliberate investment in the expanded sales organization for long-term sustainable growth, with sales and marketing expenses expected to decline sequentially in Q3 and Q4.

    Changes in pancreatic cancer treatment landscapeCurrent

    Significant changes

    Mitigation: Currently evaluating the changes and will provide an update on the go-forward pancreatic strategy after completing the analysis.

    What to watch in Q3 FY26

    5

    TriNav Advance 510(k) clearance

    Near term
    CurrentReview running past MDUFA goal
    TargetClearance

    Why it matters

    Expands liver market access to small distal vessels and allows microcatheter choice, crucial for market penetration.

    Review is running past the MDUFA goal. But we remain in close dialogue with the FDA and hope to receive clearance in the near future.

    Q&A highlights

    3

    Can you provide more details on the productivity improvement of the new sales reps hired in Q1, their launch trajectory, and their expected impact in Q3 and Q4?

    The new sales reps, hired by April, now have two quarters of experience, and their contribution is expected to increase substantially in the second half of the year. Management is pleased with the caliber of talent and confirmed that productivity is on track with internal models, with many reps exceeding internal metrics.

    “So now you're seeing our reps in the back half of the year, they have 2 quarters under their belt. And we're starting to see that contribution increase pretty substantially in the back half of the year.”

    asked by Frank Takkinen · answered by Mary Szela

    2 min read5 chapters

    Detailed Narrative

    01

    Commercial Expansion & OBL Reimbursement

    TriSalus significantly expanded its commercial footprint in the first half of the year, more than doubling its sales force, which is now ramping towards full productivity. This expansion is already yielding positive results in terms of engagement and productivity. A key development is the new CMS G-code, effective July, which extends reimbursement for the TriNav system into physician office settings (OBLs). This is expected to meaningfully expand patient access and clinician flexibility, particularly for liver embolization procedures and other emerging indications like uterine artery embolization, which are increasingly performed in OBLs.

    02

    Clinical Evidence Generation

    The company is actively generating clinical evidence with 11 active studies across 27 sites, involving over 400 TriNav-treated patients. The PEDIR study, evaluating TriNav's improvement in tumor-to-normal ratio in HCC and hypovascular tumors, has been submitted for peer-reviewed publication. New prospective trials, PREDICTT (hypovascular tumors) and PRESSURE (liver metastases), are either actively enrolling or launching in Q3 FY26, designed to provide head-to-head data to drive clinical adoption. Additional large studies, PAIR and a TACE study in neuroendocrine tumors, are planned for kick-off in H2 2026.

    03

    Pipeline Expansion Beyond Liver

    TriSalus is pursuing significant growth opportunities in non-liver indications, including uterine, thyroid, and genicular artery embolization, which collectively represent an addressable market of approximately $2.5 billion in the U.S. Momentum is building in uterine artery embolization with an expanded study enrolling well, and the PROTECT registry for thyroid artery embolization is on track to deliver multicenter U.S. data in Q1 2027. The new OBL G-code is anticipated to be a significant accelerant for these emerging indications by removing reimbursement barriers.

    04

    Nelitolimod & Pancreatic Programs

    The consolidated PERIO Phase I data readout for nelitolimod is on track for the second half of 2026. Separately, TriSalus is evaluating significant changes in the pancreatic cancer treatment landscape to refine its broader pancreatic strategy. An update on the go-forward strategy will be provided after this analysis is complete.

    05

    Real-World Evidence & Cost Savings

    A recent webinar highlighted compelling real-world evidence from a study evaluating over 300 million patient lives, including 1,200 matched patients treated with PEDD. The data demonstrated TriNav's clinical benefit in challenging patients with high disease burden and complex anatomy, particularly in scenarios with poor anticipated outcomes. Health economics and outcomes research (HEOR) data also showed average cost savings of $7,700 in certain procedures, further validating the platform and catalyzing adoption.

    AI-generated summary of the company’s earnings call. Not investment advice.