Q3 2024 TriSalus Life Sciences Inc Earnings Call
Okay.
Good morning, and welcome to life.
Life Sciences third quarter 2024 earnings conference call.
Currently all participants are in a listen only mode.
A question and answer session towards the end of today's call.
This call is being recorded for replay purposes.
Speaker Change: I would like to turn the call over to your host Jim Young Senior Vice President of Investor Relations and Treasurer at Tri salaries for a few introductory comments.
Speaker Change: Thank you all for participating in today's call joining me today from trace balanced life Sciences, our Marysville long, President and Chief Executive Officer, and Shaun Murphy Chief Financial Officer earlier. This morning, <unk> Dallas released financial results.
Speaker Change: <unk> for the third quarter ended September 32024.
Speaker Change: A copy of the press release is available on tracks Dallas's website before we begin I would like to remind you that we will be making forward looking statements based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties and our actual results may differ materially. Please see the risk factors in our SEC.
Mary: The SEC filings for additional details and with that I'll turn the call over to Mary.
Mary: Good morning, everyone and thank you for joining us today.
Mary: I'm pleased to report that <unk> has delivered a quarter of strong growth and that we continue to execute the key initiatives that will enable us to continue this upward trajectory.
Mary: With our expanding market footprint innovative product launches and strategic clinical advancements we're on track to drive sustained growth of 50% annually for the foreseeable future.
Mary: For Q3 trade Telus reported a total revenue of $7 3 million.
Mary: Selecting a 42% growth compared to the same period in 2023.
Speaker Change: Several key factors have Jeremy its growth new account activation deeper penetration within existing accounts continued education around our permanent finance specific reimbursement income.
Speaker Change: And compelling clinical data supporting the use of trying out in treating complex patients.
Speaker Change: On the commercial side trade Dallas had been steadily expanding its footprint across all high volume markets by the end of the year, we expect to have approximately 50 commercial personnel.
The mix of sales and clinical specialists.
Speaker Change: Our goal is to establish a comprehensive coverage of high procedure markets. This expansion is central to our comprehensive in a 50% annual growth over the coming years.
Speaker Change: I'll turn the call over to Shaun Murphy, our Chief Financial Officer for a detailed review of our financial results later in the call.
Speaker Change: Our commitment to engaging the interventional radiology and hospital community remains strong.
Speaker Change: We continue to share the growing body of clinical evidence showcasing the value of our P. E D D technology and delivering more targeted therapy to tumors.
Speaker Change: Especially in complex patient cases.
Speaker Change: As we approach the year end I want to draw your attention to the important catalysts we're focused on.
Speaker Change: The launch of China at large.
Speaker Change: Clinical initiation of our protect registry trials or the use of China, and multi nodular quarter by the end of the year.
Speaker Change: Our new E. T O R data that includes an additional year of trying out watch outcome.
Speaker Change: Further substantiates the efficacy of China in treating complex patients with.
Speaker Change: This comprehensive analysis will be published in the first half of 2025 with key highlights to be discussed later in my opening remarks.
Speaker Change: Trying to have to point out to launch in the first half of 2025 phase one clinical trial data in Uveal melanoma, liver metastasis, and our initiation of partnership discussion.
Speaker Change: Final completion of 13 patients enrolled imperial three.
Speaker Change: With data summary, and next steps determined in the second half of 2025.
And lastly, significant reduction in expenses and cash burn.
Speaker Change: With the goal to become EBITDA positive in 2025.
Speaker Change: So let me begin with our product launches, we're excited to announce that the launch of China up large and try guide catheter is underway and going well. This launch signifies our commitment to addressing the embolization challenges of complex patients and extends the China product that China product portfolio.
Speaker Change: To offer interventional radiologists, the full suite of pressure enabled drug delivery solution for all treatment approaches.
Speaker Change: The current China of device addresses duffel dynameter up to three five millimeters for mental and sub mental approaches.
Speaker Change: A significant number of cases are low bar procedures and require a larger diameter device.
Speaker Change: Which provides full access to the $375 million chemo and radio embolization market.
Speaker Change: Before launch we conducted an extensive market evaluation over six months and received highly favorable feedback on its performance track ability and navigating complex vascular anatomy.
Speaker Change: Approved tumor response reduce complications and resource utilization.
Speaker Change: Additionally, we are on track to launch China have to point out in the second half of 2025, our next generation device designed to offer enhanced tracking abilities.
For more precise navigation and placement.
Speaker Change: Disadvantaged Persian builds on the original China of technology.
Speaker Change: Providing clinicians with improved control during procedures.
Speaker Change: With its enhanced track ability.
Speaker Change: <unk> 2.0 aims to elevate procedural accuracy inefficiency.
Speaker Change: Further supporting optimize the patient outcome.
Speaker Change: In parallel with our commercial and new product efforts.
We're advancing that deliver clinical program. This.
Speaker Change: This program is designed to demonstrate enhanced efficacy and safety across a broad spectrum of complex difficult to treat patients.
Speaker Change: Through investigator initiated studies further underscoring the impact of our P. E D D technology.
Speaker Change: A central theme of this program will be to investigate innovative approaches to highlight the impact of improved therapeutic delivery and enhanced safety through normal tissue sparing when using the <unk> system. In these complex patients. We aim to explore the potential of combination therapies with three endarterial glass.
Speaker Change: Land Chemo and radio embolization delivered via the <unk> system, which we will expect will demonstrate enhanced efficacy and overcome resistance mechanisms in difficult to treat cancers.
Speaker Change: We define these complex patients as though involving one or more of the bottling.
Speaker Change: Previous embolization and therapy, multifocal diffuse where by low bare liver lesions.
Speaker Change: This is significant tumor burden large tumors greater than eight nanometers inside multiple comorbidities, including liver dysfunction, and hypo vascular tumors, which means they have poor blood supply.
Speaker Change: Now on last quarter's call I introduced a new target patient population using trying now to treat multi now to their quarters.
Speaker Change: The protect study, which stands for pressure enabled retrograde occlusive therapy with embolization for control of thyroid disease.
Speaker Change: Has been initiated by Dr. Juan Camacho and Dr. Ralph just mono at Sarasota General Hospital.
Speaker Change: The goal is to enroll 100 patients across five leading academic sites.
Speaker Change: Demonstrate enhanced efficacy reduced side effects and lower cost of treatment versus surgery.
Speaker Change: Multinational they're going here, it's quite common with approximately 5% of the adult population founding of Nigel.
Speaker Change: Some publications report are prevalent.
Speaker Change: Up to 50% in individuals over the age of 50.
Speaker Change: We estimate that this procedure expands the potential addressable market for China.
Speaker Change: By approximately 50000 procedures, representing an incremental market opportunity of $400 million.
Speaker Change: In addition to focusing on the liver embolization and pancreatic market.
Speaker Change: Market opportunity for technologies is now over $1 billion.
Speaker Change: Additionally, this new procedure utilizing trade China is eligible for the same <unk> reimbursement code, allowing for seamless integration into current billing practices.
Speaker Change: Today these patients with more extensive numerous nodule I referred to surgery due to symptoms of pressure dysphasia choking sensation or airway obstruction.
Speaker Change: Risks about thyroidectomy include hypothyroidism, hyperparathyroidism, recurrent laryngeal nerve injury and bleeding.
Speaker Change: <unk> also used a typically restricted to the treatment of single module.
Speaker Change: Land embolization with China.
Has several significant benefit.
Speaker Change: Since it is minimally invasive.
Speaker Change: Uses injection of particles to create ischemic injury to the thyroid nodule.
Speaker Change: And allows the patient to have minimal downtime.
Speaker Change: We also intend to open additional deliver studies in.
Speaker Change: In the first half of 2025, all aimed at elucidating the benefits of <unk> technology and other complex patient types.
We are enthusiastic about the deliver program's potential to highlight our technology with unique benefits.
Speaker Change: And provide the clinical information and physicians need to confidently select them for their patients.
Speaker Change: Additionally, we look forward to providing an update to another year of data in our <unk> study looking at real world data, capturing both safety and clinical complications for China as compared to conventional catheters over the 'twenty 'twenty to 'twenty two 'twenty three time period.
Speaker Change: This study is an additional year of trying of utilization from a large 300 million patient dataset covering 98% of all U S. Payors.
Speaker Change: These updated data, which compared key characteristics and clinical complication rates of 603 P. E. D D patients with those of 16210 non P E patients.
Speaker Change: Provide valuable insight into the benefits of <unk> technology that would otherwise have taken many years to accumulate your alternative approaches for example, like randomized controlled clinical trial.
Speaker Change: Key findings included the following.
Speaker Change: Significantly increase the amount of chemotherapy to delivered to the tumor.
Speaker Change: China have reduced 30 day inpatient stays reduced overall clinical complications.
Speaker Change: <unk> rates of Parison pieces, which means the reduced times number of times the patient had fluid drained from their abdomen due to a failing liver function.
Speaker Change: And reduce overall healthcare costs due to post procedural complications.
Speaker Change: As we continue to expand the commercial adoption of P. E D D in the U S.
Speaker Change: We are also engaging medical oncologists and under Chronologist to educate them on its benefits and discuss integrating its used into their embolization treatment algorithms.
Speaker Change: The medical community is interested in understanding the value of ped and different applications in the value of enhanced therapeutic delivery to tumors with reduced toxicity.
Speaker Change: Now, let me turn to Nella told them that we presented phase one results from the period, one pressure enables regional immuno oncology clinical trial at the society of immunotherapy of cancer meeting Sydney.
Speaker Change: This trial investigating the use of pressure enabled drug delivery or P. E. D. D of MELA told them on in Uveal melanoma liver metastases.
Speaker Change: Now I told them that has been shown in preclinical studies to favorably modulate myeloid cells, suggesting that P. D. D administration could enhance the efficacy of immune checkpoint inhibitors.
Speaker Change: The phase one study was a dose escalation trial of paddock arterial NELA told them on <unk>.
Speaker Change: In Uveal melanoma liver metastases and included three cohorts for a total of 67 patients cohort.
Speaker Change: Which is 13 patients received <unk> as monotherapy cohort B, which was 34 patients received another.
Speaker Change: Another told Mod plus vivo and cohort C received MELA told my plus an evo and <unk>.
Speaker Change: The primary endpoints were progression free survival and overall survival of the 67 patients treated 69% had a prior systemic therapy and a substantial number had significant tumor burden of greater than five centimeter lesions and 27% of the patients and 10 liver lesions.
Speaker Change: 36% of the patients key findings included grade three or four treatment related adverse events, which occurred in 13% of patients most frequently in cohort C where checkpoint inhibitor administration was involved.
Speaker Change: The recommended phase two dose with two milligrams of melatonin odd plus nemo or it'd be Nemo and that was 23 patients.
Speaker Change: The one year old with 74, 7%.
Speaker Change: The median OS was 26 months.
Speaker Change: One year PFS was 47, 6% and the median OS was eight seven months disease control rate was 65%.
Speaker Change: With similar survival outcomes in checkpoint refractory and the checkpoint naive patients.
Speaker Change: <unk> was similar in the checkpoint refractory, which was six patients was 80%.
Speaker Change: And the checkpoint naive with 17 patients at 71%.
Speaker Change: The overall survival in the PFS outcomes, we're not dependent on HLA restriction status.
Speaker Change: Among evaluable patients the clearance of circulating tumor DNA CTV MAA was 50% and clinical benefit correlated with reduced tumor M. D. S. CS and increased IL 15, and IL 18 levels.
Speaker Change: The results suggest that P. D D Administrated melatonin mod combined with checkpoint.
Speaker Change: Provides promising clinical benefits and durable survival in heavily pretreated patients with uveal melanoma liver metastases, regardless of HLA status.
Speaker Change: We are highly encouraged by the results of Purion, which substantiate our hypothesis that <unk> administered B E. E. D. D can create a more favorable tumor microenvironment in the liver.
Speaker Change: These findings suggest that <unk> has the potential to amplify the therapeutic impact of immune checkpoint inhibitors, particularly for heavily pretreated patients with uveal melanoma liver metastases.
Speaker Change: Given the challenging prognosis associated with Uveal melanoma liver metastasis, we are deeply committed to expanding access to this innovative therapeutic approach to that and we're actively exploring strategic partnerships to advance this indication further.
Speaker Change: High unmet need in this patient population underscores our commitment to exploring partnerships that can accelerate this program and broaden its reach.
Speaker Change: We believe by collaborating with Likeminded organization, we can unlock the potential of this therapy and drive impactful clinical them that advancements in this challenging indication.
Speaker Change: Regarding <unk> III a phase one clinical study that includes a novel pancreatic retro grade Venus approach with Ped evaluates mellow Tomas ability to modulate the tumor microenvironment and promote systemic tumor immune responses. The study involved delivery of melatonin.
Innovative pancreatic infusion device were demonstrated both strong delivery performance and a favorable safety profile.
Speaker Change: This breakthrough technology is designed to deliver targeted therapeutic agents <unk>.
<unk> to the pancreas potentially enhancement enhancing treatment precision and efficacy for pancreatic condition.
Speaker Change: The target population with patients with locally advanced pancreatic disease, who have failed at least one line of standard therapy to.
Speaker Change: To date, we completed enrollment of 13 patients and are evaluating their safety and three dose levels.
Speaker Change: There has been no severe safety events related to the P. E D D devices or the procedure and nella told him out of infusions with P. E. D. D had been well tolerated with potentially favorable intra tumoral and systemic immune signal.
Speaker Change: These findings indicate the safety of regionally delivered NELA toll mod mono therapy via Ped support further exploration using combinatorial approaches we're enthusiastic about the potential of <unk> combined with our novel pancreatic infusion technology.
Speaker Change: And once the final set of data emerges mid 2025.
Speaker Change: Outline next steps.
Based on our experience with over 90 patients treating with NOLA tomasz for primary and metastatic liver tumors. This drug is well tolerated in these patients.
Speaker Change: And he has immune and clinical facts that may support favorable clinical outcomes.
Speaker Change: In particular, the ability of <unk> to mediate viral effects on M. D S seed and M, two macrophages and liver metastasis.
Speaker Change: Be beneficial in these patients.
Speaker Change: After exploring <unk> several phase one clinical trial.
Speaker Change: We have focused our efforts on partnering uveal melanoma liver metastases and determining next steps for locally advanced pancreatic cancer.
Speaker Change: Most importantly, this focus clinical approach represents a pivotal milestone in our company's evolution positioning us to be EBITDA positive, which will drive long term sustainability and value creation.
Speaker Change: To achieve this significant milestone of becoming EBIT positive in 2025, our company will focus on accelerating revenue growth, while remaining committed to operational discipline. We're.
Speaker Change: We're targeting a sales a 50% growth in 2025 supported by a robust strategy that includes expanding our market penetration and chemo and radio embolization optimizing sales team performance.
Speaker Change: And driving adoption of China, and China is large.
Speaker Change: Launching China to point out to provide a complete solution to interventional radiologists.
Speaker Change: Additionally, we will implement cost control measures and streamline operations to improve margins ensuring that every dollar contributed to profitability.
Speaker Change: By aligning the efforts of our sales product and operational teams.
Speaker Change: Were confident in hitting this milestone and creating long term value for shareholders.
Speaker Change: Before I turn the call over to Sean I'll close by saying, we're pleased with the company's performance and confident in our ability to execute our company building strategy.
Speaker Change: We remain on track against our objective to achieve over 50% topline revenue growth advance our pipeline and strengthen our operational foundation with that I'll turn it over to Shaun Murphy to provide an update on our financial performance in the quarter.
Shaun Murphy: Good morning, everyone and thank you Murray.
Shaun Murphy: As Mary mentioned at the top of the call <unk> achieved outstanding performance in the third quarter of 2024, driven by the continued success of the Tri NAV technology in the U S. Our.
Shaun Murphy: Our revenue.
Totally driven by the success of the Tri Nab device in the U S reached $7 3 million in the third quarter.
Shaun Murphy: This sales achievement represents a substantial 42% increase compared to the same period in 2023.
Shaun Murphy: Year to date revenue stands at $21 2 million, reflecting a 66% growth compared to the nine months of last year.
Shaun Murphy: This quarter, we added 42, net new hospital accounts and our utilization rose to $15 three units per account.
Shaun Murphy: From $13 five units per account in the third quarter 2023.
Shaun Murphy: <unk> has a track record of growth illustrated on slide one.
Shaun Murphy: Since our product launch in 2020, the company has achieved a compound annualized growth rate exceeding 50%.
Shaun Murphy: We project 2024 sales to grow by more than 50%, reaching 28% to $30 million.
Shaun Murphy: In the third quarter of 2024, we maintained a robust gross margin of 86% consistent with our year to date margin.
Shaun Murphy: And up from 84% for the nine month period in 2023.
Shaun Murphy: This margin strength is due to increased production volumes improved batch yields and operational efficiencies.
Shaun Murphy: Our Westminster, Colorado facility has already produced more Tri net units in the first three quarters of 2024 than all of last year.
Shaun Murphy: In R&D expenses for the third quarter.
Shaun Murphy: And year to date totaled $4 2 million and $14 7 million.
Shaun Murphy: Down, 56% and 33% respectively compared to the same period in 2023.
Shaun Murphy: These reductions reflect the.
Shaun Murphy: <unk> of patient enrollment in the <unk> phase <unk> trials.
Shaun Murphy: With further decreases anticipated throughout the remainder of the year.
Our investment in sales and marketing continued to increase and supportive of our growth strategy.
Shaun Murphy: In Q3 and year to date, we allocated $6 1 million and $18 8 million up 31% and 65% from the same periods in 2023.
Shaun Murphy: These investments focus on expanding our sales force and clinical specialists to drive high account uptake and for the recent trying to have large launch this month.
Shaun Murphy: General and administrative expenses for Q3 and year to date totaled $4 7 million and $13 3 million, marking a decrease of 48% in Q3 and 24% in the first nine months compared to the same periods.
Shaun Murphy: In 2023.
Shaun Murphy: Operating losses in Q3 and year to date were negative $8 7 million and negative 28 6 million respectively.
Shaun Murphy: And an improvement from $18 8 million in 2023 third quarter.
Shaun Murphy: And $40 2 million in the first nine months of 2023.
Shaun Murphy: These reductions stemmed from increased sales higher gross margin and decreased R&D expense.
Shaun Murphy: Noncash based compensation was $1 4 million in Q3, and $3 7 million year to date.
Shaun Murphy: Moving to the balance sheet, we closed the quarter with $11 3 million in cash and cash equivalents.
Shaun Murphy: Plan to draw 10 million from the orbiting bad debt facility early in the first quarter of 2025.
Shaun Murphy: Together with existing cash and other liquidity sources. This funding is expected to sustain our operations through 2025.
Shaun Murphy: Upon reaching certain 2025 sales milestones, we can draw an additional $15 million from the or B Ben <unk>.
Shaun Murphy: <unk> late in 2025.
Shaun Murphy: We anticipate being EBITDA positive for 2025, and achieving positive cash flows in the second half of 2025.
Shaun Murphy: For the first time, we are providing guidance for 2025.
Shaun Murphy: We expect sales growth of over 50% in 2025, driven by expanding <unk> market share.
Shaun Murphy: But trying to have large launch and further market development supported by the delivery program.
Shaun Murphy: Operating expenses should decline by 20%, reflecting reduced clinical cost from the conclusion of the <unk> phase one trials and lower G&A expects expenses following onetime costs associated with becoming a public company.
Shaun Murphy: This guidance does not account for any potential milestones or upfront payments from partnerships related to <unk>.
Speaker Change: And now I'll turn the call back to Mary for closing remarks.
Mary: Thank you Sean and thank you to everyone for joining today's call as we wrap up I want to reiterate that we're highly encouraged by the strong momentum we've seen this quarter.
Mary: The solid financial performance.
Mary: Key upcoming product launches and strategic milestones, we've discussed today demonstrate <unk> ongoing commitment to delivering innovative life changing solution for our patients and creating long term value for our shareholders. Looking ahead, we're on track to achieve our goal of over 50% revenue growth in two.
Mary: Thousand 25 underpinned by the successful rollout of China at large China, a 2.0 and key clinical trials like the protect registry for.
Mary: We're also excited about our progress with Noah told them out and the potential for our partnerships and collaborations in oncology as we continue to execute our growth strategy and invest in our future.
Mary: We remain confident in our path to achieving EBITDA positivity in 2025 positioning us for sustained growth and success in the years ahead. Once again. Thank you for your continued support we look forward to keeping you updated on our progress in achieving new milestones together have a great day.
Speaker Change: Thank you.
Speaker Change: Ladies and gentlemen to ask a question. Please press star one one on your telephone and wait for your name to be announced so withdraw your question. Please press star one again.
Speaker Change: Please.
Speaker Change: And our first question comes from the line of Jason <unk> with Roth.
Speaker Change: Hi, Thanks for taking the questions.
Maybe to start in terms of the guidance definitely appreciate you providing 2025 guidance.
Speaker Change: In terms of what's in those assumptions I guess two questions related to that one.
Speaker Change: Is that primarily going to be TACE antero or can we anticipate.
Speaker Change: Adoption into other areas.
To drive that revenue.
Speaker Change: And then secondly is there any parallel one or so carry a 1% to three cost associated with next year and those cost assumptions.
Thank you for the question.
Speaker Change: And thank you for the coverage you initiated very appreciative of that.
Speaker Change: In terms of our our guidance for next year.
Speaker Change: Our sales force is primarily targeted in the taste and term market. So our operating assumptions are only to capture those accounts. However, even in the current year. We are getting early usage and a few other areas that we're doing are registered.
Speaker Change: Thank you fees, we have some thyroid cases being done.
Speaker Change: And so.
Speaker Change: It's difficult to quantify the amount of it I would expect that it is very very small at this level.
Speaker Change: That's fair and then in terms of the cost and I guess, if I could add a question to that.
Speaker Change: In terms of advancing.
Speaker Change: <unk>.
Speaker Change: Are you going to seek a partner or for all for all all indications at least that Youre looking at right now or.
Speaker Change: Is that something youre going to take on by yourself.
Speaker Change: At this point Jason.
Speaker Change: Don't know until we.
Speaker Change: <unk> talked to partners we've had.
Speaker Change: Few inquiries on our plans and we've been.
Speaker Change: Quiet on it until today, when we've announced that we are going to partner rather than taking it forward.
Speaker Change: Uh-huh.
Speaker Change: So.
Speaker Change: Go ahead, sorry, sorry.
No.
Speaker Change: I just meant that specific to you via all the other two indications you may go it alone and that's still not yet to be decided.
Yes.
Speaker Change: <unk>.
Speaker Change: Ontario too for HCC.
Speaker Change: And.
Speaker Change: The other indications that we were looking at we are not going forward with that it has to be.
Investor investigator programs that we would support but we are not doing.
Speaker Change: Any formal programs Imperial too and then <unk> three.
Speaker Change: As Mary mentioned, we did.
Speaker Change: Increase our enrolment over our target in <unk> III.
Speaker Change: Later in this year.
Speaker Change: Year.
Speaker Change: We will not get the full dataset until mid next year and then we will make a decision there but the question you asked was what a partner demand.
All indications.
Given that this is a product used in the hospital the same channels.
Speaker Change: Pretty much the same users.
Speaker Change: I would expect that to be raised but given that we havent advanced our dataset.
Chris Wilde: Chris Wilde.
While we're partnering it it may be something that slept open.
Speaker Change: Okay. Thanks for the color on that maybe I'll ask one more and then jump back in queue and Thats.
Speaker Change: In terms of the pancreatic retrofitted venous infusion system.
Speaker Change: Is there any.
Speaker Change: Advancement in terms of reimbursement for that or anything we can expect in terms of milestones.
Speaker Change: The reimbursement of adoption.
Mary: Yeah. This is Mary.
Speaker Change: Great question, we're right in the middle of submitting for a category three code, we'll do that in February of 2025, we just worked with the society of interventional radiology, they've reviewed the entire application and there'll be leading and supporting it with the submission.
Speaker Change: And then based on the timeframe of these category III codes, we expect to get approval in mid 2025. Once we have a category three code and then we determine how to advance. It then we will submit for a category one code.
Great. Thanks for the detail and good quarter. Thank you everybody.
Thank you.
Thank you.
Speaker Change: Next question comes from the line of Suraj Kalia with Oppenheimer <unk> company.
Speaker Change: Thank you.
Speaker Change: Larry Sean can you hear me alright, yes.
Speaker Change: Hear you fine.
Speaker Change: Thank you for taking my question so.
Speaker Change: One question for you and one for Sean Sean Let me start out with your piggybacking on Jason's question.
Speaker Change: For FY 'twenty five Sean how are you thinking of utilization I believe you mentioned Q3 was $15 three units per site.
Speaker Change: Just walk us through your 50% year over year guide.
Where does utilization factor into the calculus.
Speaker Change: And also how are you thinking about new store versus same store for China.
Speaker Change: We we have detailed.
Speaker Change: Assumptions for our plan.
Speaker Change: And.
Speaker Change: On the.
Speaker Change: New account.
Speaker Change: And for the usage our average usage.
Speaker Change: From a constant customer same store.
Speaker Change: <unk>.
Speaker Change: Our plan for next year is to increase to an.
Speaker Change: On average for the year of $17 five.
Speaker Change: So up about two units.
And the rest of our growth as new accounts.
Speaker Change: We off we opened over 100, new accounts this year.
Speaker Change: And.
Speaker Change: A lot of that had to do with getting permanent reimbursement in the beginning of the year, we had a very very high first quarter.
Speaker Change: Okay.
Speaker Change: And we're forecasting 50.
Speaker Change: New accounts next year in 2025.
Speaker Change: And then we have a significant increase to the training of large.
Speaker Change: Which we have approximately $5 million and the forecast for that.
Speaker Change: Got it that's great color.
Speaker Change: Maybe one question for you and I'll hop back in queue.
Speaker Change: Mary multi nodal Avoiders right. This is my first call and I'm curious how do you think within the treatment paradigm.
Speaker Change: My understanding always is especially multimodal corridors.
Speaker Change: The non toxic ones right radio iodine in LTE for a usually the standard of care, but youre comparing it to surgery.
Speaker Change: Just kind of help us walk through the thought process here and what should we think in terms of outcomes.
Speaker Change: Not only versus surgery, but just in the whole treatment paradigm. Thank you for taking my questions.
Speaker Change: We are very excited about this opportunity to be honest with you. This was brought to us by group of physicians, who have been using it.
Speaker Change: And got very excited about what they saw so.
Speaker Change: You know obviously Nigel is on the on the thyroid are quite common.
Speaker Change: And the small modules or if it's single module of our pretty much handled today by ablation, that's not the market. We're pursuing however, we do have a positioning wants us to use ablation and our technology together.
Speaker Change: Shrink the nozzles, but multi notch other quarter.
Speaker Change: Can be treated with iodine, it's not it's not an optimal treatment what it typically is surgery.
Speaker Change: And that's if you look at all the claims data primarily surgery in the U S and other parts of the world they'll use item, but they don't do that typically here and the challenge with surgery is you know this is a pretty invasive procedure.
Speaker Change: The risk of stroke.
Speaker Change: <unk> damage.
Speaker Change: It is reasonably high and Theres also the possibility of damaging the thyroid tissue or intervening too much in the thyroid tissue, where there is long term you know levothyroxine replacement when.
Speaker Change: <unk> Synthroid for Abbvie long ago, and spent a long time on what it means to get a patient euthyroid. So theres a lot of complications associated with it.
Speaker Change: And what physicians are seeing with our technology is.
Speaker Change: Previous embolization, they had to go into that subclavian, which obviously had.
Speaker Change: Some risk of stroke and that really frightened physicians from using just traditional catheters to do this procedure, what we can do with ours because of the ability to retrograde still the tumor we go to the into the inferior.
Speaker Change: Thyroid arteries, only we don't go into that.
The <unk> are the carotid arteries at all.
Speaker Change: And it's about a 30 minute 25 minute procedure, you can actually see it fill it up with bland beads.
Speaker Change: And it's a 30 minute procedure and it really shrinks that substantially.
Speaker Change: And a lot of patients. This is full treatment and the beauty of it is that they can be retreated and you don't disrupt thyroid function and so lot of excitement about this what we're gonna be measuring as endpoints in the registry are a number of key endpoint one of the things that we know right away is that patients have.
Speaker Change: Immediate you know a lot of their discomfort a lot of these modules can actually cause compression on the trade. Yes. So they feel like they are choking a little bit or they have trouble swallowing and that's what really brings them to the position, we see that that dissipates quite rapidly. So we're gonna be measuring how quickly the naturals resolve what is their three months outcomes.
Speaker Change: And all of the toxicity outcomes associated with it. So we're very very excited what's really unique about thyroid.
Speaker Change: It is incredibly common affair.
<unk> mainly women.
Speaker Change: They claim that literally almost 5% of women over 50 all habit.
Speaker Change: We're targeting and I think we're being conservative about 50000 procedures in the U S. There's also a lot of excitement to use ablation and our technology together, where could you use.
Trying to have first shrink the tumor and then ablate. It at the end, which gives the interventional radiologists to procedures. So theres quite a level of excitement about that so this is gonna be a big area of focus for us we already have five sites lined up.
Speaker Change: One of our key positions literally just posted something on Twitter and he had 10 patients. After his post two weeks ago, So a pretty exciting opportunity for us.
Speaker Change: Excellent many thanks.
Speaker Change: Thank you.
Speaker Change: And our next question comes from the line of William.
Speaker Change: <unk> <unk> with Canaccord Genuity.
Speaker Change: Great. Thanks.
Speaker Change: Thanks for taking my questions.
Speaker Change: So just to start out on 2024 guide.
Speaker Change: Commentary that greater than 50% I think consensus.
Speaker Change: We're sitting at $8 2 million.
Speaker Change: Wanted to get your comfort level with that as we use for a jump off point for for 'twenty four for 25.
Speaker Change: Bill This is Sean.
Speaker Change: Yes that is.
Speaker Change: A very good number.
Speaker Change: And for the full year.
Speaker Change:
Speaker Change: We've announced that.
Speaker Change: The range is between 28 and $30 million.
Speaker Change: Okay and then.
Speaker Change: Just as we think about it I mean, it's typical for companies together their third fourth year post commercialization to really hit seasonality than you expected. This and we saw this.
Speaker Change: You are pretty much flat sequentially, but I was wondering if you could just give us some color as to maybe monthly cadence as you went through July August September and into October just to give us confidence in that in that fourth quarter rebound and any other puts or takes that youre kind of seeing as we as we go into the.
Speaker Change: <unk> ended the year here.
Speaker Change: Sure Bill.
Speaker Change: Yes.
Speaker Change: <unk> been in this position for three cycles now the third one.
Speaker Change: And they.
Speaker Change: I'm still trying to find.
Speaker Change: Our standard cadence during the year.
Speaker Change: I do believe the remnants of Covid.
Speaker Change: Made it quite different.
Mike: Mike My first year here.
Mike: It is getting back to what I would have expected.
Mike: In the third quarter.
Mike: We were flat with the second quarter, but the <unk>.
Mike: <unk> of the month was was quite different.
Mike: In the summer months of July and August we saw very low utilization.
Mike: Not not a lot of cases.
Mike: And.
Mike: We were a bit concerned about that and then in September it was the biggest month.
A month, we ever had it was.
Mike: Bigger by 10% to 15% over the previous biggest one which I think was a year end kind of close.
Mike: So the pattern was a bit unusual and the other part of looking at it year to year in the third quarter of 23.
Speaker Change: Right. After we went public.
Speaker Change: Added a number of salespeople in that particular quarter was.
Speaker Change: Which on our chart was.
Speaker Change: Very very high quarter, so we have a tough comp.
But we did see a dramatically different utilization.
Speaker Change: In July and August than we've seen in prior years.
Speaker Change: Okay.
Speaker Change: Okay and then.
Speaker Change: Just help us understand I think you burned about $11 million in the third quarter.
Speaker Change: Yes.
Speaker Change: You finished.
Speaker Change: Quarter with $11 million, you talked about kind of dropping.
Speaker Change: The spend and pulling another $10 million in Q1 to kind of and you believe you'll be able to get there.
Speaker Change: Is this just you.
You expect a lot of spend decrease in R&D sequentially and then even maybe on the G&A was there are risks was there is there something else going on that youre youll be able to drop the spend that much.
Speaker Change: It's mostly consultants.
Speaker Change: Lawyers and accounting firms.
Speaker Change: We did so many registrations we did so many.
<unk> S fours.
Speaker Change: We incurred a lot of costs coming out of a new spec process.
Speaker Change: So.
Speaker Change: In the second quarter, we saw.
Speaker Change: A leveling off of our G&A administrative public company costs.
Speaker Change: In the third quarter, it went down pretty substantially.
Speaker Change: We expect that to continue to go down.
Speaker Change: Quarter to quarter.
As we just don't have to do the filings that we've we've had to in the past.
Speaker Change: We have also.
Speaker Change: We're involved in a number of banking activities that affected our our G&A to a certain degree and so we're on.
Speaker Change: A drop.
Speaker Change: But the biggest the biggest change is just finishing up our parallel trials.
Speaker Change: They are expensive trials and.
Where we've enrolled our last patients.
This particular quarter.
Speaker Change: And.
Besides that.
Speaker Change: Most of those.
Speaker Change: Clinical costs get transferred into doing closeout at facilities.
Speaker Change: Filing various reports on the patient follow ups and so forth.
Speaker Change: Which are administrative more administrative activities internally.
So our use of consultants.
Speaker Change: <unk>.
Speaker Change: Drop.
Very very much and so you are right our cash burn in the third quarter was.
Speaker Change: Tad over $11 million.
Speaker Change: We expect the fourth quarter to be down.
In the range of four to $4 5 million and that cash burn will continue to drop until we're at a point where in the second half of next year, we will be cash flow positive.
Speaker Change: Okay.
Great and then my last question just the <unk> update.
Speaker Change: It's interesting so.
Speaker Change: What should we read into these comments in terms of pancreas regarding efficacy you've added more pain.
Speaker Change: Pushed out the readout until mid next year.
Speaker Change: What's the takeaway, we see it safe, but we're not really clear on efficacy I mean, what's the messaging youre trying to give us here and thanks for taking my questions sure. So we enrolled in the fourth quarter three more patients for a total of 13.
Speaker Change: And.
What we're trying to do is just get longer follow up period. So we get more than 10 patients in total data one of the other things that we're we're just assembling now bill and I think this is really going to give us kind of the confidence in terms of how we move forward is what was really unusual in this trial.
Speaker Change: We were able to get quite extensive tissue samples pre and post of the administration of <unk>.
Speaker Change: Jeff Scott all those samples now.
Speaker Change: And so what we're doing is we're going through that data with a with a panel of immunologists and some oncologists to sort through that because this wasn't a randomized clinical trial. So what we really want to see if are we modulate the.
Speaker Change: The tumor micro environment in a way that we think and the positive results are we seeing can we attribute them completely to nella told them hard and that's really what we need to do and we won't really have all that data of the paper last few patients in follow up probably until March or April. So that's why we think middle of the year.
Speaker Change: Is the right one we still remain very enthusiastic about it I think what we need to do it see that correlate of data and make sure that's consistent with where we're we're reading the data today makes sense.
Speaker Change: It does thanks.
Speaker Change: Thank you.
Speaker Change: And our next question comes from the line of Justin Walsh with Jones trading.
Speaker Change: Great.
Speaker Change: Hi, Thanks for taking the question I'm wondering if you can comment on the intersection of trying out and trying to have large target markets.
Speaker Change: Many physicians are likely to use one versus the other or both.
Speaker Change: So that's a great question, we got a lot of clarity on that this year as we started to grow.
Speaker Change: Physicians, each physician will probably use both.
Speaker Change: How large is used and how China is used is really just pertains to vessel size oftentimes the physician doesn't really know until they get into the procedure room and they see where they want to go and they see the vessel size they'll kind of eyeball, it and determine what products to use one of the challenges that we had this year without having trying to have large.
Speaker Change: As we have try now, but then they looked at the vessel size and said Hey, I can't get in with the China of I need a larger vessel, one and we lost that opportunities for China. So we estimate that we were not getting access to about 30% of the pace and payer market. So now we have a full portfolio.
Speaker Change: So every physician uses both.
Speaker Change: Because they have they have patients that have vessel sizes that range anywhere from one five centimeters all the way up to buy so we're very excited now to have a full suite of products for the interventional radiologists.
Speaker Change: Got it thanks, and one more question for you I'm just curious if you can comment on the competitive landscape. If theres any other novel delivery products are catheters that you see emerging that could be competitors for trying to ever tried that large.
Speaker Change: We don't see anyone in China or in the liver.
Speaker Change: One of the things that we feel very comfortable about is our new Hicks picks procedural code was written specifically for our technology and how we modulate pressure and flow, which we think creates those unique favorable benefits of the technology.
Speaker Change: And then on our pancreatic device, we don't see any other competitor that accesses the Venus anatomy and also uses pressure in the way that we do.
Speaker Change: There is an arterial version for.
Speaker Change: For accessing the pancreas.
Speaker Change: That is currently in development and I think they have a readout this fourth quarter, but in terms of having.
Speaker Change: Life technology that modulates pressure.
Speaker Change: We don't see one one of the things that we have done is creating created IP around how we modulate pressure and flow. So we think we have a pretty good sense around that technology and and have a nice tollbooth, if anyone tries to come into our space.
Speaker Change: Great. Thanks for taking the questions.
Speaker Change: Thank you I'll now hand, the call back over to CEO Mary Zillow for any further remarks.
Mary Zillow: Thank you everyone really appreciate your interest and support in the company have a great day.
Speaker Change: Ladies and gentlemen, thank you for participating this does conclude today's program and you may now disconnect.
Speaker Change: Okay.
Okay.
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