Q1 2024 TriSalus Life Sciences Inc Earnings Call

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Operator: Good morning, and welcome to TriSalus Life Sciences' first quarter 2024 earnings conference call. Currently, all participants are in listen-only mode. We will facilitate 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 of Investment Relations and Treasurer at TriSalus, for a few introductory remarks.

Speaker Change: Good morning, and welcome to Trust Dallas, Lifesciences first quarter 2024 earnings Conference call.

Speaker Change: Currently all participants are in listen only mode. We will facilitate a question and answer session towards the end of today's call.

Speaker Change: 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 of Investor Relations and treasurer across Dallas for a few introductory remarks.

Jim Young: 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 financial results for the first quarter ended March 31st, 2024. A copy of the press release is available on TriSalus's website.

Thank you all for participating in today's call joining me today from trace Dallas Life Sciences are married XOMA, President and Chief Executive Officer, John Murphy, Chief Financial Officer, and Dr. Steven Katz, Chief Medical Officer.

Speaker Change: Earlier this morning trace Dallas released financial results for the first quarter ended March 31, 2020 for a copy of the press release is available on trade balances website.

Jim Young: Before we begin, I would like to remind you that management will make statements during this call that are 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. Therefore, any statements contained in this call, other than statements of historical fact, are forward-looking statements. All forward-looking statements, including, without limitation, statements relating to our projected sales, costs, operating results, and cash runway, business strategies, objectives, and growth, product value and adoption, and anticipated product launches, future clinical data, and future product development and approvals are based upon our current estimates and various assumptions.

Speaker Change: Before we begin I would like to remind you that management will make statements. During this call that include 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 $19 95.

Jim Young: 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 forward-looking 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, as well as in our other reports filed periodically with the SEC.

Speaker Change: 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 projected sales costs operating results and cash runway business strategies objectives and grow.

Speaker Change: <unk> products value and adoption and anticipated product launches future clinical data and future product development and approvals are based upon our current estimates and various assumptions.

Speaker Change: 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.

Jim Young: 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, May 15th, 2024. And with that, I'll turn the call over to Mary. Good morning.

Speaker Change: <unk> 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.

Speaker Change: Only as of the live broadcast today may 15th 2024, and with that I'll turn the call over to Mary.

Mary T. Szela: Good morning, and thank you all for joining today's call. We're thrilled to kick off the discussion by highlighting our strong start in the first quarter of 2024, setting an optimistic tone for the rest of the year. I'm expressing my sincere appreciation for the dedication and efforts of the entire TriSalus team in delivering exceptional results for our patients, physicians, and shareholders. Their unwavering commitment to our mission continues to drive our success, enabling us to achieve significant milestones, advance our pipeline, and reshape our company's future.

Mary: Good morning, and thank you all for joining today's call.

Mary: We're thrilled to kick off the discussion by highlighting our strong start in the first quarter of 2020 for setting an optimistic tone for the rest of the year.

Mary: I'm expressing my sincere appreciation for the dedication and effort and the entire <unk> team in delivering exceptional results for our patients physicians and shareholders.

Mary: Their unwavering commitment to our mission continues to drive our success, enabling us to achieve significant milestones it means our pipeline and reshape our company's future.

Mary T. Szela: Today, we'll discuss this quarter's key highlights and provide updates on our groundbreaking drug delivery technology, PEDD, and our promising investigational therapeutic, melatolamide, for liver and pancreatic indications. Starting with quarterly performance, I'm delighted to report a remarkable 116% growth in revenues, all of which is from the sale of Trinab compared to the same period last year. This growth, fueled by permanent reimbursement, promising clinical data, and Salesforce expansion, underscores our position as one of the fastest growing medtech companies with another consecutive quarter of over 50% growth. We've been actively engaging with the interventional radiology and hospital community to share the outcomes of our health, economic, and outcome research study.

Mary: Today, we will discuss this quarter's key highlights and provide updates on our groundbreaking drug delivery technology E D D.

Mary: Promising investigational therapeutic now with telematics for liver and pancreatic indications.

Mary: Starting with quarterly performance I'm delighted to report a remarkable 116% growth in revenues.

All of which is from the sale of trying out compared to the same period last year. This growth fueled by permanent reimbursement promising clinical data in salesforce expansion underscores our position as one of the fastest growing med tech companies with another consecutive quarter of.

Mary: Over 50% growth.

Mary: We've been actively engaging with the intervention radiology and hospital community to share the outcomes of our health economic and outcome research study.

Mary T. Szela: This study underscores the value of TRINAB, particularly in treating complex patients with diverse clinical challenges. We're updating our analysis to include the latest clinical data from 2023, further reinforcing TRINAP's potential to become the standard of care for these patients. This data, in addition to our previous clinical data, demonstrates the value of TRINEV in complex patients, defined by patients with one or more of the following. Previous embolization or therapy, multinodal or bilobar lesions, an essentially significant tumor burden, very large tumors greater than eight centimeters in size, multiple comorbidities, hypovascular tumors, and diffuse tumors.

Mary: This study underscores the value of trying out, particularly in treating complex patients with diverse clinical challenges.

Mary: We're updating our analysis to include the latest clinical data from 'twenty to 'twenty three further reinforcing <unk> potential to become the standard of care for these patients.

Mary: This data in addition to our previous clinical data demonstrates the value of trying out in complex patients.

Mary: Find by patients and probably one or more of the following.

Mary: Previous embolization or therapy, multi nodal or by lower lesions essentially significant tumor burden.

Mary: Very large tumors greater than eight centimeters in size multi.

Speaker Change: Multiple comorbidities hypo vascular tumors and diffuse tumor gives.

Mary T. Szela: Given this robust data, we are positioning TRINAP to become the standard of care for these patients and implementing a range of educational and reimbursement support programs to facilitate the technology's adoption within the high-volume embolization hospital. As we move ahead, we're eagerly anticipating the launch of Trinab Large in the second half of the year, along with the forthcoming clinical results from our Nelotolomide trials across various cancer indications. Enrollment has been successfully concluded for our Phase 1 clinical trial for uveal melanoma liver metastases, PERI-O1, intrahepatic cholangiocarcinoma, and hepatocellular cancer, PERI-O2, with enrollment nearing completion for pancreatic cancer, PERI-O3.

Speaker Change: Given this robust data we are positioning <unk> to become the standard of care for these patients.

Speaker Change: In implementing a range of educational and reimbursement support program.

To facilitate the technologies adoption within the high volume Embolization Hospital.

Speaker Change: As we move ahead, we're eagerly anticipating the launch of train at large in the second half of the year.

Speaker Change: Along with the forthcoming clinical results from our Nellix hold them IDE trials across various cancer indications.

Speaker Change: Enrollment has been successfully concluded for a phase one clinical trial for Uveal melanoma liver metastases.

Speaker Change: One <unk>.

Speaker Change: Intrahepatic, Cholangiocarcinoma and hepatic cellular cancer perrier too with enrollment nearing completion for pancreatic cancer periodic III.

Mary T. Szela: We are currently awaiting the predetermined follow-up period to conclude, during which we will thoroughly evaluate the data and strategize our next steps in terms of which indications to pursue. Our dedication to innovation remains steadfast, and we look forward to presenting promising data from PERI-02 at the upcoming American Society of Clinical Oncology Annual Meeting. In addition to our clinical advancements, we've made significant strides in optimizing manufacturing and gross margins, achieving an impressive 85% gross margin this quarter.

Speaker Change: We are currently awaiting the predetermined follow up period to conclude during which we will thoroughly evaluate the data and strategize. Our next steps in terms of which indications to pursue.

Speaker Change: Our dedication to innovation remains steadfast and we look forward to presenting premises promising data from carrier to at the upcoming American Society of clinical oncology annual meeting.

Speaker Change: In addition to our clinical advancements we've made significant strides in optimizing manufacturing and gross margin achieved.

Speaker Change: Achieving an impressive 85% gross margin this quarter.

Mary T. Szela: These efforts, coupled with our strategic investments and focus on operational efficiency, position us for sustained growth and pipeline advancement. With recent positive developments in reimbursement, robust clinical data, and the dedication of our seasoned executive team, we're confident in our ability to execute our company building strategy. Our objectives of achieving over 50% top line revenue growth, advancing our pipeline, and strengthening our operational foundations remain firmly on track. In summary, we're pleased with this quarter's progress, and I'll now let Sean delve deeper into our financial performance.

Speaker Change: These efforts coupled with our strategic investments and focus on operational efficiency position us for sustained growth and pipeline advancement.

Speaker Change: With recent positive developments in reimbursement.

<unk> clinical data and the dedication of our seasoned executive team, we're confident in our ability to execute our company building strategy, our objective of achieving over 50% topline revenue growth advancing our pipeline.

Speaker Change: Wine and strengthening our operational foundation remain firmly on track.

Speaker Change: In summary, we're pleased with this quarter's progress and I'll now, let Shaun delve deeper into our financial performance Sean.

Sean Edward Murphy: Good morning, everyone. And thank you, Mary.

Sean: Good morning, everyone and thank you Mary.

Sean Edward Murphy: I am pleased to announce that TriSalus achieved outstanding results in the first quarter that ended March 31st, 2024. Our revenue, solely driven by the success of the TriNav device in the US, reached $6.5 million. This sales achievement represents the highest quarterly sales in the company's history, reflecting a very strong 116% increase compared to the same period in 2023. TriSalus has a track record of growth, as illustrated on slide one, which shows the company has grown at a compound annualized growth rate of approximately 50% since the launch of the product in 2020.

Sean: I am pleased to announce that <unk> achieved outstanding results in the first quarter that ended March 31, 2024, our revenue solely driven by the success of the <unk> device in the U S reached six 5 million.

Sean: This sales achievement represents the highest quarterly sales in the company's history, reflecting a very strong 116% increase compared to the same period in 2023.

Speaker Change: <unk> has a track record of growth as illustrated on slide one.

Speaker Change: Which demonstrates the company has grown at a compound annualized growth rate of approximately 50% since the launch of the product in 2020.

Sean Edward Murphy: We continue to forecast 2024 growth over 50%, and this segment of the business, excluding Nelotolamide clinical costs, is expected to approach positive EBITDA late in 2024. In the first quarter, we captured 32 net new hospitals. This amount is favorable to our internal projection, due to Penta customer demand at the end of 2023 associated with achieving our previously announced permanent reimbursement in December. Our account utilization reached 14.5 units per account compared to 11.2 units per account in the first quarter of 2023.

Speaker Change: We continue to forecast 2024 growth over 50%.

Speaker Change: In this segment of the business, excluding NELA Tullow my clinical costs is expected to approach positive EBITDA late in 2024.

Speaker Change: In the first quarter, we captured 32 net new hospital accounts.

This amount is favorable to our internal projections due to pent up customer demand.

Speaker Change: At the end of 2023 associated with achieving our previously announced permanent reimbursement in December.

Speaker Change: Our account utilization reached 14 five units per account compared to 11.2 units per account in the first quarter of 2023.

Sean Edward Murphy: We are proud to report a robust gross margin profile of 85% in the first quarter of 2024, compared to 78% in the first quarter of 2023. This favorable margin in 2024 can be attributed to increased factory volume, improved batch yields, and other operating efficiencies. Our facility in Westminster, Colorado, can support our growth over the next five years with minimal capital investment. Regarding our investment in research and development, expenses for the first quarter of 2024 totaled $5.9 million, an increase of 4% from the first quarter of 2023. We expect our clinical costs to decrease for the balance of 2024 as we finish follow-up and analyze the data from the trial.

Speaker Change: We are proud to report a robust gross margin profile of 85% in the first quarter of 2024 compared to 78% in the first quarter of 2023.

Speaker Change: This favorable margin in 2024 can be attributed to increased factory volumes.

Speaker Change: Improved batch yields and other operating efficiencies our.

Speaker Change: Alrighty and Westminister, Colorado can support our growth over the next five years with minimal capital investment.

Speaker Change: Regarding our investment in research and development expenses for the first quarter of 2024 totaled $5 9 million an increase of 4% from the first quarter of 2023.

We expect our clinical cost to decrease for the balance of 2024 as we finish follow up.

Speaker Change: And analyze the data from the trials.

Sean Edward Murphy: Our investment in sales and marketing continues to increase in support of our growth strategy. In the first quarter of 2024, we invested a total of $6.7 million, a 106% increase from the first quarter of 2023. These investments are closely tied to our ongoing Salesforce expansion from 10 representatives at the beginning of 2023 to our current level of 27 representatives and seven clinical specialists. General and administrative expenses totaled $4.6 million in the first quarter of 2024, an increase of 30% compared to the first quarter of 2023.

Speaker Change: Our investment in sales and marketing continues to increase in support of our growth strategy and.

Speaker Change: In the first quarter of 2024, we invested a total of $6 7 million or 106% increase from the first quarter of 2023.

Speaker Change: These investments are closely tied to our ongoing sales force expansion from 10 Representatives and the beginning of 2023 to our current level of 27 representatives and seven clinical specialists.

Speaker Change: General and administrative expenses totaled $4 6 million in the first quarter of 2024, an increase of 30% compared to the first quarter of 2023.

Sean Edward Murphy: These increases are primarily related to the costs associated with becoming a public company in August of 2023. Our Operating Losses for the First Quarter of 2024 totaled $11.7 million, compared to losses of $10.1 million in the first quarter of 2023. As mentioned earlier, the increased losses in 2024 can be attributed to higher operating expenses in sales and marketing, R&D, and general administrative expenses. However, these expenses were primarily offset by the increased gross margin from increased TRINAB revenues and improved gross margin profile.

Speaker Change: These increases are primarily related to the costs associated with becoming a public company in August of 2023.

Speaker Change: Our operating losses for the first quarter of.

Speaker Change: 2024 totaled $11 7 million compared to losses of $10 1 million in the first quarter of 2023.

Speaker Change: As mentioned earlier the increased losses in 2024 can be attributed to higher operating expenses and sales and marketing R&D and general and administrative expenses.

Speaker Change: These expenses were primarily offset by the increased gross margin from increased trying to have revenues and improved gross margin profile.

Sean Edward Murphy: As noted in our press release, we are pleased to announce that we closed a debt financing facility in April with OrbiMed. Under the terms of the credit agreement, we borrow $25 million at closing and have an aggregate up to an additional $25 million available in two tranches at our option, subject to achievement of certain revenue thresholds. This financing, assuming we borrow the entire $50 million, along with our $4 million in cash and cash equivalents on hand as at the end of the quarter, and other sources of liquidity, is expected to provide sufficient runway to fund our operation through the end of 2025. Now I'll turn the call back to Mary for closing remarks.

Speaker Change: As noted in our press release, we are pleased to announce that we closed the debt financing facility in April with or be met.

Speaker Change: Under the terms of the credit agreement, we borrowed $25 million at closing and have an aggregate up to two addition up to an additional $25 million available in two tranches at our option.

Speaker Change: Subject to achievement of certain revenue thresholds.

Speaker Change: This financing assuming we borrow the entire $50 million, along with our $4 million in cash and cash equivalents on hand as at the end of the quarter and other sources of liquidity.

Speaker Change: We are expected to provide sufficient runway to fund our operations through the end of 2025.

Speaker Change: And now I'll turn the call back to Mary for closing remarks.

Mary T. Szela: Thank you, Sean, and a warm welcome to all who are participating in the call today. In brief, at TriSalus, we're thrilled to share the significant strides we've made in bolstering our Trinib business and advancing our perio-clinical programs. Furthermore, we're proud to announce the successful extension of our cash runway, a testament to our commitment to shaping a promising future for our company and shareholders. With that, I'm pleased to open the floor to answer any questions you may have. Your interest in our company and your inquiries and perspectives are genuinely valued.

Mary: Thank you, Sean and a warm welcome to all who are participating in the call today in grief at <unk>, we're thrilled to share the significant strides we've made in bolstering, our China business and advancing our <unk> clinical program.

Speaker Change: Furthermore, we're proud to announce the successful extension of our cash runway a testament to our commitment to shaping a promising future for our company and shareholders with that I'm pleased to open the floor to answer any questions. You may have your interest in our company and your inquiries and perspectives are genuinely values.

Operator: Thank you. To ask a question, please press star 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Justin Walsh with Jones Trading. Your line is now open.

Thank you to ask a question. Please press star one or your telephone and wait for your name to be announced.

Speaker Change: To withdraw your question. Please press star one again.

Speaker Change: Please standby, we compile the Q&A roster.

Speaker Change: Our first question comes from the line of Justin Walsh with Jones trading your line is now open.

Unknown Analyst: Hi, congrats on an excellent quarter and thanks for taking the question. I'm wondering if you can provide some color on what we can expect from the upcoming data readouts for Nelotolomod and how you anticipate these informing your decisions about which indications to move forward with.

Justin Walsh: Hi, congrats on the excellent quarter and thanks for taking the question.

Justin Walsh: I'm wondering if you can provide some color on what can we what we can expect from the upcoming data readouts for <unk> and how you anticipate these informing your decisions about which indications to move forward with.

Mary T. Szela: Good question, Justin. Right now, there are no further updates on the clinical data. What we're waiting for is for all the recently enrolled patients to mature. So, we had enrolled quite a number of patients in the December timeframe, early January timeframe. So we'll wait till they get to the 6 month mark, and then, you know, we're going to do a comprehensive evaluation. I think as a small company, our approach is going to be, we're only going to pursue an indication where we think the competitive environment is low, that we have a very significant treatment effect, that we have a very clear regulatory pathway, potentially, even an accelerated, you know, approval, definitely a breakthrough indication.

Speaker Change: Good question Justin.

Speaker Change: Right now.

Speaker Change: No further updates on the clinical data what we're what we're waiting for is for all the recently enrolled patients to mature.

So we had enrolled quite a number of patients in the December timeframe early January timeframe. So we'll wait till they get to the six month, Mark and then we're going to do a comprehensive evaluation I think as a small company. Our approach is going to be we're only going to pursue an indication where we think the competitive environment.

Speaker Change: Mint is low that we have a very significant treatment effect that we have a very clear regulatory pathway potentially even an accelerated.

Speaker Change: Approval definitely a breakthrough indication.

Mary T. Szela: And we'll make that recommendation to the board in the 3rd quarter. But we also, as we go through this whole process, we're going to be looking across a range of different indications, and we likely will only pursue 1 just based on our ability to finance it.

Speaker Change: And we will make that recommendation to the board in the third quarter.

Speaker Change: But and we also as we go through this whole process, we're gonna be looking across a range of different indications and we likely will only pursue one.

Speaker Change: Based on our ability to finance however, the data is really spectacular and we'll we'll look at other options as well.

Unknown Analyst: Got it, thanks. And one more quick one for me, I'm just wondering if you can provide some commentary on your sort of preparation efforts for the commercial launch of TriNav Large and any color on enthusiasm.

Speaker Change: Got it thanks, and one more quick one for me just wondering if you can provide some commentary on your.

Speaker Change: Sort of preparation efforts for the commercial launch of try not large and.

Speaker Change: Any.

Speaker Change: Color on enthusiasm.

Speaker Change: Desire you've gotten from the physician community that to have that available.

Mary T. Szela: Yeah, I mean, right now, one of the things that we've done at TriSalus, which you think is a very important approach for any new product, what we did, instead of just launching it into the market and learning as you go, we've gone through a fairly extensive market evaluation, where we go to a number of key users, understand how they would use it, get feedback on them, and we're going to be completing And today, I think what we validated is that having a larger size of trineb is very important, particularly in cases where the viscosity of the solution is more, you know, thicker and more difficult to perfuse.

Speaker Change: Yeah, I mean, right now one of the things that we've done at <unk>, which you think is a very important approach.

Speaker Change: Or any new product, what we've done and instead of just launching it into the market and learning as you go we've gone through a fairly extensive market evaluation, where we go to a number of key users understand how they would use it get feedback on them and we're gonna be completing that in the third quarter launching in the fourth quarter and to date I.

Speaker Change: What we validated is having the larger size of trying out is very important particularly in case cases.

Speaker Change: Where the viscosity of the solution.

Mary T. Szela: And this is where the trineb large makes a big difference. I think number two, just vessel size. For some of these patients where they have a very significant tumor volume, this is going to be a very appropriate type of technology. So I would say overall, we validated the need in the marketplace. I think there's quite a bit of enthusiasm about it, and then we'll plan to launch in the fourth quarter.

Speaker Change: Or is it more sticky.

Speaker Change: And more difficult to perfused and this is where the large makes a big difference.

Speaker Change: I think number two just vessel size for some of these patients where they have a very significant tumor volume. This is going to be a very appropriate type of technology. So I wouldn't I would say overall, we validated the need in the marketplace. I think there is quite a bit of enthusiasm about it and then we'll plan to launch in the fourth quarter.

Mary T. Szela: Great, thanks for taking Thank you. As a reminder,

Operator: Thank you. As a reminder, to ask a question at this time, please press Star 1-1 on your touchtone telephone. And I'm currently showing no further questions at this time. I'd like to turn the call back over to Mary Szela for closing remarks.

Speaker Change: Great. Thanks for taking my questions.

Speaker Change: Thank you.

Speaker Change: <unk> to ask a question at this time, please press star one one Oreo touchstone telephone.

Speaker Change: Okay.

Speaker Change: And I'm currently showing no further questions at this time I would like to turn the call back over to Mary Zeller for closing remarks, well first of all thank you all for taking time to listen to our call. Today, we really appreciate your interest and involvement in the company and appreciate your time. Thank you everyone.

Mary T. Szela: Well, first of all, thank you all for taking the time to listen to our call today. We really appreciate your interest and involvement in the company and appreciate your time. Thank you, everyone.

Operator: This concludes today's conference call. Thank you for your participation. You may now disconnect.

This concludes today's conference call. Thank you for your participation you may now disconnect.

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