TriSalus Life Sciences, Inc. (TLSI) Earnings

Management highlights

- Strategic Commercial Progress * The company more than doubled its commercial footprint in the first half of 2025 to build out infrastructure for TriNav adoption; new hires are hitting internal productivity targets on schedule, with contributions expected to ramp in the second half of 2026. * In July 2026, CMS granted a new G-code extending TriNav reimbursement to the physician office-based lab (OBL) setting, a fast-growing site of care for embolization procedures that improves patient access via shorter wait times and more flexible scheduling. - Clinical Pipeline and Evidence Generation * 11 active clinical studies are underway across 27 sites, enrolling over 400 patients treated with TriNav. The completed PETR investigator-initiated trial has been submitted for peer-reviewed publication, and the completed Tri-Find 90 trial remains in data review. * The prospective PREDICT study at MD Anderson for hypovascular tumors launched in Q2 and is actively enrolling; a second randomized trial for liver metastases will open enrollment in Q3 2026. Two additional large prospective studies are scheduled to launch in H2 2026, including one comparing TriNav to standard microcatheters for liver metastases and another for neuroendocrine tumors in collaboration with the University of Pennsylvania. * A large real-world HEOR study of over 1,200 matched embolization patients found TriNav delivers clinical benefit for high-burden, complex patients, with average per-procedure cost savings of $7,700. * The 510(k) clearance review for TriNav Advance, which extends pressure-enabled drug delivery (PEDD) to small distal vessels via any third-party microcatheter, is past its MDUFA goal, but the company remains in close communication with the FDA and expects near-term clearance. * For non-liver emerging indications: the expanded uterine artery embolization (UAE) study is on track to hit its 50-patient enrollment target, and UAE is expected to be an early beneficiary of OBL reimbursement; the thyroid artery embolization PROTECT registry has hit its interim analysis enrollment target, with first multicenter U.S. data expected in Q1 2027; the genicular artery embolization program has completed its pilot registry and is advancing formal trial design. The Nelotolimab phase 1 program remains on track to deliver consolidated data readout in H2 2026. - Market Opportunity * The combined U.S. addressable market for TriNav across liver embolization and the three non-liver indications is approximately $2.5 billion. Recent positive combination therapy data for liver cancer from AstraZeneca's Emerald III trial is expected to increase adoption of liver-directed procedures, where TriNav has a strong market position.

Guidance

- Management maintains full year 2026 revenue guidance at $54 million to $57 million, representing 19% to 26% year-over-year growth over 2025. - Management expects sequential revenue growth improvement from Q2 2026 to Q3 2026, with a stronger fourth quarter. - Sales and marketing expenses are expected to decline sequentially in Q3 and Q4 2026, after elevated one-time costs from first half sales force expansion are completed. - Management expects existing cash reserves of $46.3 million are sufficient to fully fund the company's approved strategic growth plan.

Segment performance

Trifalus Life Sciences reports only overall corporate-level financial results, with no breakdown of product segment performance provided. Total Q2 2026 revenue was $11.4 million, a 1.7% increase from $11.2 million in Q2 2025. Gross margin for the quarter was 86.8%, up from 83.9% year-over-year. Research and development (R&D) expenses were $3.1 million, down from $3.7 million year-over-year. Sales and marketing expenses were $11.4 million, up from $7.2 million year-over-year, driven by commercial footprint expansion. General and administrative expenses were $5.1 million, down from $5.9 million year-over-year. Adjusted EBITDA loss was $7.1 million, wider than the $5.3 million loss in Q2 2025. The company ended the quarter with $46.3 million in cash on hand.

Risks & headwinds

- Forward-looking statements related to 510(k) clearance timing, trial enrollment, commercial adoption, and future revenue are subject to material risks and uncertainties that could cause actual results to differ materially from expectations. Key risks are detailed in the company's periodic SEC filings including Forms 10-Q and 10-K. * The TriNav Advance 510(k) clearance review is already past its original MDUFA goal date, introducing uncertainty around the timing of this product launch. * Expansion into OBL settings and new non-liver indications could require unplanned incremental sales resources, which would increase operating costs above current projections.

Analyst Q&A

• Q: What productivity trajectory is the expanded first quarter 2026 sales force on, and what impact should we expect in the second half of 2026?

  A: All new sales representatives were hired by April 2026, after the expansion launched in February, and they are already performing in line with the company's internal model. The company notes it has attracted higher-caliber talent than historically possible, with many new reps exceeding internal metrics, and contributions are expected to increase substantially in the second half of 2026.

• Q: Which indications will benefit most from the new OBL reimbursement G-code, and will additional sales and marketing resources be needed to capitalize on this opportunity?

  A: Liver embolization, which is already seeing patient migration from hospital settings to OBLs, and non-liver procedures including UAE that are commonly performed in OBLs will be the primary early beneficiaries. The opportunity came earlier than expected, and the company is currently developing plans to capture this growth.

• Q: What is the overlap in sales call points and treating physicians between the core liver market and the emerging non-liver indications? Will additional sales resources be required to expand into these adjacent markets?

  A: Most interventional radiologists maintain broad general practices that cover both liver embolization and non-liver embolization procedures even at large academic centers, with only rare subspecialization. Many physicians already use TriNav for liver procedures and have independently started using it off-label for UAE after seeing its clinical value. The company expects no incremental sales resources will be required initially to capture these adjacent opportunities, as the existing sales force already calls on the same physicians.