Good morning. And welcome to TriSalus Life Sciences Fourth Quarter and Full Year 2023 Earnings Conference Call. Currently, all participants are on a listen-only mode. We will be facilitating a question-and-answer session towards 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 your host, Jim Young, Senior Vice President, Investor Relations and Treasurer at TriSalus for a few introductory comments.

Thank you all for participating in today’s call. Joining me today from TriSalus Life Sciences are Mary Szela, President and Chief Executive Officer; Sean Murphy, Chief Financial Officer; and Dr. Steven Katz, Chief Medical Officer. Earlier this morning, TriSalus released unaudited financial results for the fourth quarter and full year ended December 31, 2023. A copy of the press release is available on TriSalus’ 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 made 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 related to our sales and operating trends, business and hiring prospects, financial and revenue expectations, the timing of the filing of our annual report on 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. TriSalus 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, April 1, 2024. As noted in our press release, TriSalus has filed or will soon file a Form 12b-25 Notification of Late Filing with the SEC related to the company’s annual report on Form 10-K for 2023. This filing provides the company an extension of up to 15 days to file the company’s annual report. If the company files its annual report within such a 15-day period, the annual report will be deemed to have been filed timely, as if we had filed on the due date prescribed by the SEC. The company filed Form 12b-25 primarily due to the calculation of non-cash stock compensation expense caused by data errors associated with a transition to a new service provider in 2023. As a result, the operating results provided on the call today are unaudited and subject to potential adjustments. And with that, I’ll turn the call over to Mary.

Good morning and thank you for joining today’s call. I’m pleased to reflect on the significant milestone achieved by TriSalus in 2023, marking a pivotal year in our company’s journey. We’ve made substantial progress in advancing our disruptive drug delivery technology, PEDD, aimed at enhancing therapeutic outcomes for liver and pancreatic tumors. Furthermore, I’m also excited to highlight our strides in integrating our technology with our investigational immunotherapeutic nelitolimod, a Class C toll-like receptor non-agonist across various liver and pancreatic indications. Together, these advancements signify our commitment to advancing outcomes for patients suffering with liver and pancreatic tumors. This morning, I’d like to speak to you regarding our quarterly results, as well as the achievements in the past year, which have created a strong foundation for future growth. In the midst of a challenging economic environment, our people delivered 77% growth in the fourth quarter and 49% operational growth for the year. We’re pleased to report that we delivered another high growth quarter, concluding a very strong year of topline revenue growth. TriSalus continues to execute the key components of our company building strategy, which include 50% topline revenue growth, advancing our pipeline, improving manufacturing and gross margin, securing permanent reimbursement, continuing to manage costs while investing wisely, and finally, accessing the public markets. TriSalus executed on our key objectives, creating a strong foundation for future growth and pipeline advancement. First, let me begin with the accomplishments in the past year. TriSalus achieved $18.5 million in net sales, 49% growth over 2022, earning TriSalus recognition as one of the fastest-growth MedTech technologies. TriSalus received a unique and permanent HCPCS code for TriNav from CMS, C9797, which has been assigned to (APC) 5194, Level 4 Endovascular Procedures. This code can be used without restriction for any embolization or occlusion procedure consistent…

Good morning, everyone, and thank you, Mary. I am pleased to announce that TriSalus achieved outstanding results in the fourth quarter that ended December 31, 2023. Our revenue, solely driven by the success of the TriNav device in the U.S., reached $5.7 million. This sales achievement represents the highest quarterly sales in the company’s history, reflecting a very strong 77% increase compared to the same period in 2022 and up 10% sequentially compared to the third quarter. TriSalus has a record of growth, as illustrated on slide one, in which the company has grown at a compound annual growth rate of approximately 50% since our product launch in 2020. This segment of the business, excluding nelitolimod clinical costs, is expected to approach breakeven late in 2024. In terms of full year revenues in 2023, we have reached $18.5 million, a 49% increase from the prior year. These results can be attributed to several factors, including the adoption of TriNav in new accounts, increased utilization in existing accounts and the continued expansion of the salesforce, all of which has led to an increase in our market share for 2023 to 7% of the liver, TACE and TARE procedures. These factors, as well as permanent reimbursement and real-world evidence data, allow us to forecast 2024 growth in excess of 50%. In the fourth quarter, we captured 11 new hospital accounts and 55 accounts year-to-date. Our account utilization reached 12.7 units per account, an increase of 2.8 units or a 29% increase over last year. Finally, we increased our sales team with the funding we received by going public. At the beginning of 2023, we started the year with 10 representatives, and by the end of the fourth quarter, we had reached 28. We also added seven clinical specialists to support higher volume…

Thank you, Sean, and a warm welcome to all of you participating in the call today. At TriSalus, we’re delighted to share our achievements during the quarter. We continue to make meaningful progress in expanding our TriNav business and continue to advance our PERIO clinical program, both of which are shaping an exciting future for the company. With that, I will open the floor for any questions you may have. Your insights and questions are valuable to us.

Thank you, ladies and gentlemen. [Operator Instructions] Our first question comes from Jason McCarthy with Maxim Group. Your line is open.

Hi. Thanks for taking the questions. I was just wondering about the inclusion of the clinical specialists for the sales of TriNav. I guess, how many do you have currently, sorry if I missed that and how many centers could they cover to help expand adoption?

So we -- this is Mary. We currently have seven clinical specialists. And typically, what they do is, once a sales representative opens an account, trains the physicians, often the clinical specialists will spend some additional time with them until they get up to speed and feel very comfortable using the technology independently. So we use those specialists across a wider range of territories to support utilization. Your question is a good one in terms of how they drive adoption. What we have is our own internal metric for when a sales rep just doesn’t have the capacity to cover all those accounts, then we’ll deploy the clinical specialist in the territory to have him cover a number of those accounts until we get them up to speed.

Great. Thanks. And then, I guess, just sort of what are the next steps again in the pancreatic work to get to a larger Phase 2 trial?

So, Steven Katz, our Chief Medical Officer, is online. Steven, do you want to take that question, then I’ll follow up as well.

Yeah. Thanks, Mary. Jason, thanks for the question. Right now, we’re completing enrollment in the Phase 1 single agent, nelitolimod experience, so we need to complete that to establish the safety and feasibility of the drug-device combination and help establish what we feel will be the optimal biologic dose. And then, the next step would be to move into a Phase 1b in which we combine nelitolimod delivered with our technology with systemic checkpoint inhibition and we hope to start that by the end of the year, assuming the data from the Phase 1 continues to be favorable. Mary?

No. I have nothing to add. Steven has covered it completely.

Great. That’s all for me and thanks again for taking the questions.

Thank you, Jason.

[Operator Instructions] And I’m not showing any further questions at this time. I’d like to turn the call back over to Mary.

Well, thank you, everyone. We really appreciate it. Thank you, Kevin.

You’re welcome. Ladies and gentlemen, this does conclude today’s presentation. You may now disconnect and have a wonderful day.