On May 15, 2025 TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the "Company"), an oncology company integrating novel delivery technology with standard of care therapies, and its investigational immunotherapeutic to transform treatment for patients with solid tumors, reported financial results for the quarter ended March 31, 2025, and provides an operational update and revised financial guidance (Press release, TriSalus Life Sciences, MAY 15, 2025, View Source [SID1234653201]).

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"Our strong first quarter performance reflects the growing impact of our PEDD platform across a variety of solid tumor indications," said Mary Szela, President and CEO of TriSalus. "With the decision to partner Nelitolimod development following completion of the Phase 1 trials, and the expansion of our TriNav portfolio for a wide range of new applications, we are better positioned than ever to execute our long-term strategy.

"Following our recent private placement, we have made the strategic decision to further invest in our sales force expansion and clinical registries in new applications of our technology. We believe this growth-oriented strategy balances financial discipline with bold investments designed to drive long-term value creation. Accordingly, we’ve updated our 2025 guidance to reflect these strategic priorities. We are confirming our guidance of at least 50% revenue growth; however, due to increased investment, we no longer expect to be adjusted EBITDA-positive or cash flow-positive in 2025."

First Quarter 2025 Highlights

Generated $9.2 million in net sales, a 42% increase year-over-year, and sequential growth of 11% over the fourth quarter 2024.
Continued strong commercial momentum with expanded use of TriNav in liver embolization and entry into new clinical settings.
Presented compelling real-world health economics and outcomes research at SIO 2025.
Announced HCPCS code C8004 from CMS, expanding reimbursement coverage for mapping procedures using TriNav.
Launched TriNav LV and TriGuide, expanding PEDD technology to larger vessels and broader clinical utility.
Subsequent to the first quarter, the Company raised $22.0 million in gross proceeds via private placement to support continued growth.
Reached agreement with 55% of preferred shareholders to simplify capital structure and eliminate the reset provision with full preferred share conversion by mid July 2025.
Updated 2025 Guidance

TriSalus is confirming its revenue guidance of at least 50% growth due to continued commercial momentum and increasing market adoption of the TriNav platform.

While we remain focused on improving adjusted EBITDA performance, we are intentionally investing in strategic priorities that position us for long-term growth. In particular, we are deploying capital to accelerate the development of new clinical applications for our core technology and to expand our commercial organization. These investments are designed to broaden our addressable market and drive sustained value creation. As a result, we do not expect to be adjusted EBITDA positive or cash flow positive in 2025.

Financial Results for Q1 2025

Revenue, all from the sale of the TriNav system, was $9.2 million for the three months ended March 31, 2025, an increase of 42% compared to the same period in 2024 and 11% sequential growth. Revenue growth was driven primarily by increased selling resources and increased market share.

Gross margins were 84% for the three months ended March 31, 2025, compared to 85% for the same period in 2024. The current year decline was caused by decreased production due to clean room expansion.

Operating losses were $7.3 million for the three months ended March 31, 2025, compared to losses of $11.7 million for the same period in 2024. Current year reductions in operating losses are due to increased sales and reduced research and development expenses associated with the ramp-down of clinical trial spending.

Net losses available to common stockholders were $10.4 million for the three months ended March 31, 2025, compared to losses of $13.2 million for the same period in 2024. Net losses in 2025 include non-cash related losses on change in fair value of various derivatives of $1.7 million for the three months ended March 31, 2025, compared to losses of $1.5 million for the same period in 2024. The basic and diluted loss per share for the three months ended March 31, 2025, was $0.39, compared to $0.60 for the same period in 2024.

The non-GAAP measure of adjusted EBITDA is shown for the first time and reconciled in the table below as the Company believes it is an important measure of performance. Adjusted EBITDA losses were $5.5 million for the three months ended March 31, 2025, compared to losses of $10.4 million for the same period in 2024. Current year reductions in adjusted EBITDA losses are due to increased sales, reduced research and development expenses and increased stock compensation in 2025.

On March 31, 2025, cash and cash equivalents totaled $13.0 million. The Company subsequently raised $22.0 million in gross proceeds via a private placement in the second quarter. The Company believes that these proceeds provide sufficient cash runway throughout 2025 and expects to be adjusted EBITDA positive in the first half of 2026.

Conference Call & Webcast

The Company will host a conference call and webcast today at 8:00 AM eastern time to discuss its financial results for the quarter ended March 31, 2025. Parties interested in participating by phone should register using this online form. After registering for the webcast, dial-in details will be provided in an auto-generated e-mail containing a link to the conference phone number along with a personal pin. The event will also be webcast live on the investor relations section of TriSalus’ website. A replay will also be available on the website following the event.