TriSalus Life Sciences, Inc. (TLSI) Earnings

Management highlights

### Commercial Organization Expansion - The company completed a deliberate, large-scale expansion and realignment of its commercial organization, which grew to more than double its pre-expansion size, to support multiyear growth and new market opportunities. - The expansion added new executive commercial leadership (including new SVP of Sales and Commercial Operations Chris Sowd, a 20-year industry veteran with experience scaling commercial organizations), expanded talent across sales leadership, field management, and clinical specialist roles, and reworked territory footprints to address overstretched pre-expansion coverage. - As of May 2026, the expanded organization is largely complete. The 60% of territories with no rep/management disruption performed in line with expectations in 1Q2026, while the 40% of modified territories saw temporary disruption from onboarding, training, and relationship rebuilding, which explains the quarter's lower revenue. - Management expects sales productivity to improve steadily through the remainder of 2026, supported by new clinical data, new account capture, and penetration into new applications. ### PEDD Clinical and Economic Evidence - The company published a landmark peer-reviewed real-world evidence (RWE) study of its Pressure Enabled Drug Delivery (PEDD) technology, the largest study of its kind to date, including 603 PEDD patients matched to over 16,200 non-PEDD patients from a 300 million-patient claims database covering 96% of U.S. payers. - Key study findings: PEDD patients have 20.9% vs 26.4% post-procedure fatigue, a 9-fold reduction in lymphopenia at high-adoption centers (0.6% vs 5.2%), a 50%+ reduction in 30-day readmissions for TACE patients (8% vs 20.5%), 48% higher doxorubicin delivery per procedure, improved outcomes that scale with institutional adoption of PEDD, and approximately $7,700 in per-patient cost avoidance from fewer inpatient stays and complications. - There are currently 10 active PEDD studies across 24 clinical sites enrolling over 400 TriNav-treated patients, with 2 new prospective investigator-initiated trials starting enrollment in 2Q2026, and 2 completed trials targeting publication submission in 2Q2026. - Two new retrospective studies of PEDD in HCC were initiated in 1Q2026 to inform future prospective trial design. ### New Indication Development - PEDD is being developed for multiple new indications outside of liver embolization, with a combined U.S. addressable market of $2.5 billion: - Uterine Artery Embolization (UAE): A retrospective analysis presented in 2026 found a 97.5% median dominant fibroid volume reduction (vs a 50% historical average), 100% technical success with no device-related complications, and sustained symptom improvement. The company has approved expanding the study to 50 patients and is designing a prospective trial. - Thyroid Artery Embolization (TAE): The multicenter PROTECT Registry has enrolled over 50% of its target population, with preliminary results showing 100% technical/clinical success, 73% thyroid size reduction, and 71% thyroid function normalization with no major complications. It is on track to deliver the first U.S. multicenter data for PEDD-TAE. - Genicular Artery Embolization (GAE) for knee osteoarthritis: A pilot registry is complete, and the company is preparing to launch a formal clinical trial for this large, underaddressed indication. ### Pipeline Updates - The nalotolimod program remains on track to deliver a consolidated PERIO-1 readout in 2026, combining data from three completed dose-escalation studies and one ongoing investigator-initiated study as a single full dataset (the consolidated approach is for rigor, not due to any safety or efficacy concerns). - The company continues to advance its pancreatic cancer strategy, developing a novel PEDD device to overcome historical therapy delivery barriers in pancreatic disease, and expects to share more updates later in 2026. The company plans to advance nalotolimod and the pancreatic program via a partnership structure to preserve capital for near-term commercial and clinical priorities.

Guidance

- TriSalus revised its full-year 2026 revenue guidance downward to a range of $54 million to $57 million, from its prior undisclosed guidance. - The downward revision reflects two key factors: temporary 1Q2026 revenue drag from the commercial organization expansion, and a 5-month delay in FDA review for the TriNav Advance next-generation PEDD device, pushing expected clearance from the first half to the second half of 2026. The company took a prudent forecasting approach given the unpredictability of FDA clearance timing. - Management expects sequential quarterly revenue growth through 2026, with marginal sequential revenue gains in 2Q2026 as new reps complete training, and meaningful productivity-driven revenue growth in the second half of 2026 as new reps ramp up. - The company's $56.6 million in cash as of quarter-end is sufficient to fully fund its current strategic growth roadmap.

Segment performance

TriSalus Life Sciences reports consolidated financial results only and does not break out performance across distinct product segments in this call. For the first quarter ended March 31, 2026: Total consolidated revenue was $8.9 million, down from $9.2 million in the prior-year first quarter. The revenue decline was driven by temporary disruption from the company's large-scale commercial organization expansion. Gross margin was 86%, an improvement from 84% in 1Q2025, attributable to lower average unit costs for TriNav from ongoing manufacturing improvements. Research and development (R&D) expenses were $3.2 million, up from $3 million in 1Q2025, with the increase driven by higher non-cash stock-based compensation. Sales and marketing expenses were $7.4 million, up from $6.7 million in 1Q2025, reflecting the company's deliberate investment in sales force expansion, headcount onboarding, and territory development. General and administrative (G&A) expenses were $5.4 million, up from $5.2 million in 1Q2025, also due to higher non-cash stock-based compensation. The net operating loss for the quarter was $8.4 million, wider than the $7.3 million net operating loss in 1Q2025. Adjusted EBITDA loss was $5.8 million, compared to a $5.5 million loss in the prior-year period. As of March 31, 2026, the company held $56.6 million in cash and cash equivalents.

Risks & headwinds

- Uncertainty around the timing of FDA clearance for TriNav Advance: The review is already 5 months past the 30-day MDUFA goal, and unexpected further delays could push launch into 2027, impacting full-year 2026 revenue. - Sales productivity ramp of the expanded sales force may be slower than currently expected, which could result in full-year 2026 revenue coming in below the revised guidance range. - Forward-looking statements about clinical trial results, new indication adoption, and commercial growth are subject to material risks and uncertainties, including the impact of macroeconomic conditions and global events, that could cause actual results to differ materially from current expectations, as detailed in the company's periodic SEC filings. - Clinical trial success for new indications (UAE, TAE, GAE, pancreatic cancer, nalotolimod) is not guaranteed, and failure to meet trial endpoints could limit long-term growth opportunities.

Analyst Q&A

• Q: What was the sales impact of disrupting 40% of sales territories, and what confidence is there that the business will recover to hit the 2026 guidance range?

  A: 60% of undisrupted territories met performance expectations, confirming no underlying change in market demand. The 40% of modified territories saw disruption from changing both rep-physician and rep-manager relationships, plus new rep time out of the field for training, which caused the Q1 revenue hit. The expanded sales organization is now fully in place, and management expects steady month-over-month productivity growth through the rest of the year, with guidance reflecting reasonable, conservative assumptions for the ramp.

• Q: Has the company completed its plan to double the size of the sales organization, and when will hiring be fully done?

  A: The company ended up slightly expanding the hiring target beyond the original plan to double the organization, because the capital raise allowed it to attract higher-quality talent than expected. The hiring is now complete, with the organization sized to cover all 400 target accounts across liver embolization and new indications.

• Q: Can you share the size and composition of the commercial organization pre- and post-expansion, and what is the expected revenue cadence through 2026?

  A: The company does not disclose specific headcount numbers, but notes that the number of territories more than doubled, the manager-to-rep ratio was reduced from an overstretched double-digit level, and a new executive level was added to support health system and payer engagement. New reps typically take 6-9 months to fully ramp, and the company expects marginal sequential quarter-over-quarter revenue growth in Q2, with meaningful revenue increases in Q3 and Q4 as productivity improves. The high quality of newly hired reps (with deep interventional radiology experience from large pharmaceutical/diagnostic companies) supports the expected ramp trajectory.

• Q: Where will the new large real-world PEDD data have the biggest impact, and how will clinical and economic benefits drive adoption?

  A: The real-world data (collected from everyday practice across the U.S., not just tightly controlled prospective trials) validates the prospective clinical data already generated for PEDD, which builds credibility for moving PEDD toward standard of care and NCCN guideline inclusion. The finding that PEDD preserves lymphocyte counts and reduces lymphopenia has already resonated strongly with oncologists, as it removes a barrier to combining embolization with downstream immunotherapy, opening adoption beyond interventional radiology to the broader oncology community. The $7,700 per-patient cost avoidance also helps drive institutional and payer adoption.