TriSalus Life Sciences, Inc.

Good morning and welcome to Trisalis Life Sciences' fourth quarter and full year 2024 earnings conference call. Currently, all participants are in listen-only mode. We will be facilitating a question and answer session toward the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Jeremy Feffner.

Thank you all for participating in today's call. Joining me today from Trisalis Life Sciences are Mary Zella, President and Chief Executive Officer, and James Young, Chief Financial Officer. Earlier this morning, Trisalis released financial results for the fourth quarter and full year ended December 31st, 2024. A copy of the press release is available on Trisalis' website. Before we begin, I would like to remind you that management will make statements during this call that includes forward-looking statements within the meaning of federal securities laws, which are pursuant to the safe harbor provisions of the Private Securities Reform Act of 1995. Any statements contained in this call, other than the statements of historical fact, are forward-looking statements. All forward-looking statements, including, without limitation, statements relating to our sales and operating trends, business and hiring prospects, financial and revenue expectations, the timing of the filing of our annual report and Form 10-K, and future product development and approvals, are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties, including the impact of macroeconomic conditions and global events that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the risk factors section of our Form 10-Q on file with the SEC and available on EDGAR and in our other reports filed periodically with the SEC. Trisalis disclaims any intention or obligation except as required by law to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, March 27th, 2025. And with that, I'll turn the call over to Mary.

Good morning, everyone, and thank you again for joining today's call. In 2024, Trisalis executed decisive strategic moves to position the company for long-term success. Recognizing the strong commercial potential of our pressure-enabled drug delivery technology, driven by its favorable reimbursement advantages, pipeline expansion opportunities, and broader utilization in new clinical applications, we prioritize our technology platform while preserving future upside for Nelotolimod through a potential partnership and a focused pancreatic indication strategy. This strategic shift significantly reduced R&D expenses while establishing a clear path to EBITDA positivity by mid-2025 and cash flow positivity by year-end. Despite a challenging economic environment, Trisalis maintains strong commercial momentum, expanding our PEDD technology into new clinical applications. Today, I'll walk through our quarterly results and highlight our achievements over the last year, which has set the stage for continued growth. Notably, we achieved 44% growth in the fourth quarter and 59% operational growth for the full year, marking another strong quarterly performance in a high growth year. We remain committed to executing our growth strategy, which includes advancing our pipeline, expanding PEDV clinical applications, improving our manufacturing efficiencies and growth margins, and evolving our organization to sustain high growth. We are confident that these efforts will position us to drive 50% plus top line revenue growth, and in 2025, an even greater patient impact and financial success in the future. Now let me outline the 2024 accomplishments. Trisalis achieved 29.4 million in net sales, reflecting a 59.4% growth over 2023. reinforcing our status as one of the fastest-growing medtech companies. Trisalis focused on using our PEDD technology to improve outcomes for complex patients. Clinical studies in TASE and TARE demonstrated that our technology approach enhances therapeutic delivery while reducing off-target effects on healthy tissue. Our health economic and outcome research study highlighted that Trinab is predominantly used in high disease burden patients, leading to comparable outcomes to those with lesser disease burden and better transplant success rates. Trisalis increased the number of unique ordering accounts by 43% year over year, from 199 to 284. Account utilization also improved, with average units sold per ordering account rising 10%, from 12.3 to 13.5 units. Additionally, we opened up 103 new accounts, nearly doubling the 55 new accounts added in 2023. These new accounts contributed 19.5% of the total 2024 sales. The PROTECT registry study is evaluating TriNav for non-malignant thyroid goiters and nodules. The study is enrolling 100 patients across over 10 academic sites. Non-malignant thyroid girders and nodules represent a market of approximately 50,000 annual procedures and a 400 million incremental opportunity for TRINAD. The procedure is already eligible for our existing HCPCS reimbursement code, streamlining future adoption. We also published additional real-world HEOR studies leveraging our 300 million patient records. which covers over 98% of U.S. payers. The latest analysis, which was an additional year, compares 603 PEDD patients with 16,210 non-PEDD patients. These results confirmed improved patient outcomes, including lower post-procedure fatigue rates, better chemotherapy delivery, and fewer complications in HCC and tear patients. We also received recent news from CMS that they issued a new code, HCPCS code C8004 for simulation or mapping procedures using TriNav. This now becomes effective on April 1st, 2025. This reimbursement code ensures financial support for clinicians using TriNav in Medicare treatment planning. The launch of TriNav LV infusion system, and Triguide guiding catheter expanded our PEDD portfolio. These innovations optimize therapeutic delivery, improve procedural efficiency, and expand our addressable market, and offer physicians a full range of vessel size for any embolization procedure. Additionally, Trisalis completed phase one clinical trials for Nelotolamide, in uveal melanoma, liver metastasis, HCC, and intra-hepatic cholangiocarcinoma, utilizing PEDD. We are actively seeking strategic partnerships to advance this program in uveal melanoma liver metastases. Additionally, we completed enrollment in the PERIO3 Phase 1 trial, investigating melatonin in locally advanced pancreatic cancer. Final data is expected mid-2025, and we will determine next steps based on those results. Trisalis also secured up to $50 million in debt financing from OrbaMed to support TriNav growth initiatives, with $35 million accessed today. Our cash runway extends through 2025. And our Westminster site supported TriNavLarge and TriGuide launches in Q3 2024 and is preparing for launch of TriNav 2.0 in the first half of 2025. A clean room expansion is set for Q1 2025, and this will increase manufacturing capacity. Trisalis is poised for continued growth in 2025, driven by our strategic priorities, which include deeper penetration of the complex liver embolization market, expanded reimbursement for radioembolization mapping, the launch of a more trackable Trinaf 2.0, enhanced health economic and outcome research data, and new clinical study presentations at SIR, and our phase one clinical trial data reveal for Nelotolimod in combination with our novel pancreatic infusion technology. We believe TriNav has the potential to become the standard of care for complex embolization patients. Our focus will remain on strengthening clinical evidence, executing targeted educational initiatives and working toward inclusion in society guidelines. I'll close by reiterating our 2025 guidance, which reflects 50% plus revenue growth, along with positive full-year EBITDA and cash flow in the second half of 2025. We are a science-driven company with a steadfast commitment to keeping patients at the center of everything we do. Our advancements make a meaningful difference for those suffering from liver, pancreatic, and other solid tumors. In 2024, we've made significant progress in expanding the commercialization of TriNav, advancing our technology pipeline, including Nelotolimab in combination with TriNav, and strengthening our overall operations. With a focus on operational and strategic excellence, I'm confident in our ability to drive continued growth for TriNav, advance our pipeline, and deliver both short-term and long-term value for our shareholders. Most importantly, my confidence comes from our team, their dedication to patients, commitment to our mission, and relentless pursuit of innovation. I want to express my sincere gratitude to our employees and shareholders for their unwavering support. I look forward to sharing future updates on our progress and impact. Now I'll turn it over to our CFO, Jim Young.