TLSI - Earnings call 3 2023 | TriSalus Life Sciences, Inc.

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Operator

Good morning, and welcome to TriSalus Life Sciences Third Quarter 2023 Earnings Conference Call. [Operator Instructions] As a reminder, the call is being recorded for replay purposes.

I would now like to turn the call over to host Jim Young, Senior Vice President of Investor Relations and Treasurer at TriSalus for a few introductory comments.

James 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. Officer. Medical Chief Katz, Steven

Earlier this ended press for quarter financial is TriSalus XX, XXXX, released September website. the on results a available the TriSalus' morning, copy release of

remind Private we to harbor you during Before XXXX. the call forward-looking Federal safe meaning includes Securities provisions of within that would are Securities I like laws, this that will which Reform make begin, Act management statements the of the statements of to made pursuant

other to than and statements. business various and call upon of and statements historical including, future forward-looking this Any prospects, revenue assumptions. contained trends, are statements All and based proposals our without product fact in current financial operating reimbursement hiring and limitation, our development estimates statements, expectations are forward-looking and statements relating sales approvals

statements these statements. from and material and to these events including that of or reliance undue impact anticipated cause those statements. should risks or materially global on the forward-looking events macroeconomic actual Accordingly, by results you conditions could not place differ involve These uncertainties implied

or EDGAR forward-looking with or periodically statements, the with and and by Form obligation, For associated and XX-Q except whether uncertainties of to business, law, file disclaims Factors please the refer on of the as otherwise. with filed risks reports projections any list because description the other on our our information, of required available any Risk revise to TriSalus SEC. intention a events future and financial or update our new in or section SEC

to And the broadcast and the with today, XXXX. is XX, call accurate Mary. conference over only live information turn This that, call I'll of time-sensitive November contains as

Mary Szela

today Sciences publicly review the on results for greatly and today company, to third XXXX. a and we're marks people to as presence excited quarterly tumors. appreciate lives the and pancreatic We earnings thank joining towards and on improve our This our traded you liver report extend TriSalus everyone, first your to morning, with our of quarter progress Good call mission for call. us Life living

XXXX in response. of pancreas barriers founded environment via range our treatment novel immunotherapeutic immunosuppression technology of concentrations of main disease a to inhibitor was address site and checkpoint high of the the liver proprietary success on deliver combination therapeutics to that two tumors focused the attacking can and with inhibit TriSalus a enabling that in the

to and pervasive flow is underappreciated blood that Enter vessels moral a collapse uptake. in tumors, therapeutic causes problem of limiting hypertension and

tumors broad technology Enabled Drug therapeutics of been better shown into accuracy, outcomes. in predictability has and higher association at range delivery to Our with clinical Delivery, with of Pressure PEDD improved levels a enable superior tissue

allows delivery toxicity enhanced minimize the to exposure with and in tumor more tissue patients advanced delivery to therapeutic disease. normal enable increase to of decreasing treatment while PEDD

to in launched the including adenocarcinoma, that which Infusion and was infusion PEDD our TriNav hepatocellular System solid technology tumors therapeutic limit barriers Our liver overcome pancreatic leverages XXXX, metastases. uptake carcinoma in

the and date TriNav efficacy. toxicity. technology to has to by reflection tumors this concentrations avoiding have therapeutics off-target the exposure of radiologists is high-pressure of achieved limiting and while interventional impact we believe game-changing, adoption is demonstrated high normal a its to We deliver into patient ability tissue, first-of-a-kind

growth market of in the our annualized lost XX% at figure highest at delighted having TriNav quarter, an share revenue the We're Our same of third despite achieved growth this that continues the $X.X the to pandemic. And ever grown demonstrate of and to start has report million. sales rate business States. throughout at United robust the business approximately time we

This profitability. community the business superior which opportunity significant drive Our future to share gross adoption. and interventional radiology market strategic education, and single-digit in margin, us investments have physician for personnel has clinical and provides educate allowed physician sales successfully

a of more provide Following my our key metrics. Officer, results and quarterly remarks, Sean in-depth Murphy, operating Financial analysis will our Chief

In clinical receptor in data to call, In microenvironment our Katz, melanoma X performed acquired SD-XXX, we adenocarcinoma. will and Officer; with the and agonists. prior in investigational toll-like Dr. Chief Steven for Phase trial immunotherapy. addition the uveal to our favorably PERIO-XX recent share XXXX, promote to from the studies liver ability for responses PERIO-XX an TriNav Medical tumor our the to Later trial acquisition, metastases reprogram I our encouraging pancreatic technology SD-XXX demonstrated

Drug with further and biological our in concept, company's overcoming SD-XXX of critical tumors. in Delivery validate results Pressure-Enabled of barriers the combination These effectiveness the proof of solid our mechanical in treatment

our about has the and our very are remarkable of future endeavors we're by the team In commercial TriSalus. and made clinical in encouraged progress excited summary, very

At Sean discuss our our Murphy, financial operating Officer, Chief this to I'm key time, and Financial proud results to metrics. introduce

Sean Murphy

morning, everyone, TriSalus thank XXXX. to that pleased and you, third outstanding I'm in Good announce Mary. results that ended achieved quarter XX, September the

highest driven sales quarterly success the XX% TriNav a reflecting company's solely achievement revenue to same sales Our This the reached increase the by in period of XXXX. $X.X the device compared the in history represents million.

year's segment this period, of was XXXX. late is at the worth the has more growth our business growth particularly noting has that record, the making XXXX third XXXX. in This in product a launch X, on sales Slide of a a TriSalus rate remarkable. approximately the approaching as of quarter performance is It annualized breakeven grown compound of which strong illustrated company XX% since

have the can XX which factors, the prior in adoption several sales market quarter, we of increased increase the year-to-date In accounts revenues the third from $XX.X force, XX% to TriNav terms as expansion an a and of share. continued be our hospital captured of of September XX These year. in accounts, increase including XX, In reached new in accounts the has quarter accounts million, attributed results new existing XXXX, the all utilization we of our and to led year-to-date. of

account X units per last of an or Our reached increase account, a over XX units utilization increase year. XX%

XX by the by we the end XX. going the reached public. the we At Finally, beginning we funding year sales And received team of increasing we the XXXX, had third of our are representatives. with quarter, with started

into the to XXXX. expansion during continue expect and balance We sales our the force year of

margin to gross a profile third in margin report gross year-to-date the of XX.X% operating XXXX batch favorable in third quarter robust volumes, proud factory and yields to quarter XXXX. XX.X% the This margin in are in and profile other We XX.X% can improved and compared year-to-date XX.X% increase to XXXX attributed of be efficiencies.

growth support believe We capacity has in our Westminster, years. our the X facility next the Colorado to over

our quarter PERIO investment period XX% reflecting of X research investments the XXXX. million a the million, the XXXX related from Year-to-date of expenses increase development, third clinical XXXX. in third quarter our XX% $XX.X to in to $X.X and terms trials. corresponding from patient enrollments In in increase amounted primarily R&D of totaled the of in These an expenses additional are

from XX% dedication of invested XXXX. $X compared increase a in are general to evident a and to sales $X.X investments the marking the quarter These is expenses million, third totaled XXXX. and of a third XXXX. $XX.X a closely growth from quarter our marketing of for quarter marketing sales XXXX, of representing reached ongoing we Our the and Year-to-date of to total expenses. tied the administrative also In of XXXX over substantial force increase quarter million, the million XXX% third XX% increase expenses sales third expansion. Moreover,

These in of slightly our at of to $XX.X process third to administrative XXX% Year-to-date, million of $X.X costs general year-to-date in completion in related quarter million more $X.X increased XXXX over the XXXX. leaseback than ] million. onetime and amounted include costs and the [ August expenses

in compared $XX.X the losses losses $XX.X losses Year-to-date million losses quarter to for operating million quarter totaled of million $X.X $XX third XXXX. XXXX Our compared amounted million third XXXX in to in the of XXXX. to of

higher We and value believe our warrant related the aligns revenues losses This attributable resulting expenses, increased ongoing and earn-out and the and EBITDA closely gross earnings as and fair general accurate fair excludes and improved can TriNav equity earlier. by increased value liabilities. were and operating into profile. The in research figure partially sales the adjustments marketing expenses development, increased issuance, valuation in of XXXX gross margin adjustments provide profitability. of noncash liabilities mentioned These from to with contingent margin adjustments and to increased offset be the expenses tranche that operating most administrative insight

to adjustments our to resulting continue may material earnings, fluctuations It produce years. that is net in valuation note several these noncash during important the next

influenced million These to equity of earn-out we a stockholders, net year-to-date. $X.X warrant common quarter are on the significantly noncash loss third reported in terms to $XX In losses and in results of contingent the loss a the XXXX gains of million year-to-date attributable of and issuance. liabilities and $X.X valuation and liabilities, million and by tranche million $XX.X of third of quarter XXXX compared loss

Chief Steven our clinical about our excited call our In I Medical conclusion, will remain pass Dr. further With dedicated PERIO provide we our will Officer, to about highlights the mission and who to future. this, programs. Katz,

Steven Katz

everybody, We Good learning morning, thank on appreciate and you, making the patients more is the progress cancer. with your of company and about interest behalf Sean. pancreas liver in

transformative unquestionably unmet liver needs tumor results continue solid several with liver in yielded medical adenocarcinoma. While patients immunotherapy pancreatic metastasis confirm cancer, has indications, primary to and

tumor power As biologic to immunosuppression-related selected our overcome in drug a with organs. technology the approach We of combined harnesses Mary capable PEDD microenvironment and the SD-XXX, TriSalus PEDD of mechanical our challenges addressing noted these earlier, carefully barriers.

has but posed derived SD-XXX to Historically, hindering known trials prevalent in and significant optimal address TLRX to myeloid challenges. the the pancreas. dosing drug, these or MDSC acts the stimulates type and cell our to across for been in our be mechanical immunotherapy the of class to immune favorable this and specific challenges eliminate targeting other The in address cell. relative broadly seek cancer Preclinically, of SD-XXX have believe Importantly, confirm clinical we we that and of multiple delivery have properties types. that barriers biologic success trials suppressor classes are to MDSC. liver designed system a agonists

across We of Pressure PERIO-XX indications. Immuno-Oncology PERIO uveal Center In presented of Regional from launched Diego. melanoma data how highlights Enabled recent trials, the Anderson our potential XXXX, PEDD the this trial with Society enable data to a metastases. the SD-XXX MD in in has for or we involved Sapna San with Patel multiple Cancer Immunotherapy Dr. Cancer liver at patients starting believe Meeting series the

metastases. having a dose include: establishing the from device by this Key then patients encompassing study, with were intravenous safety dose with X SD-XXX, SITC indicates at liver Safety TriNav reported escalation SD-XXX single-agent across in were significant Grade with including SD-XXX treated XX% combination study. which X% treatment treatment with with treated serious intravenous checkpoint in tolerated. data no patients I enrolled the presentation data KIMMTRAK. was XX previous inhibition or cohorts with X patients in that the levels, received delivered events therapies SD-XXX well enrolled were treatment-related single-agent and Patients PEDD SD-XXX XX% adverse feeding the The had the and in various or without and inhibitors. innovative with arteries with the cohort targeting were prior Phase There liver with infusions the in After highlights combination nivolumab. checkpoint

even of The the than as with attributed lower systemically. serum. to pharmacokinetic levels limited liver expected immunosuppressive measured Patel may the through also regulatory was of examination and profile MDSC of These detailed or which liver metastasis align associated the within of in of There biopsy liver T in the be activation utilization cell checkpoint exposure safety of with high specimens. evidence rates SD-XXX data T in systemic with elimination Dr. Immunologically, inhibition. absence PEDD, the demonstrated cells and the

milligrams of at signals. disease control SD-XXX patients survival The promising Early rate X-year the optimal XX% XX.X XX%, progression-free data results. patients, in nivolumab upon ctDNA included circulating evaluable in addition combination tumor months X XX% with DNA. a of these rate data based Across revealed and in of clearance rate multiple reduction dose of a intravenous median a to immune in of a a efficacy were overall demonstrated survival X determined of efficacy the XX%. These all optimal dose

meeting. to study is locally with PERIO-XX also Lee, are study Anderson constraints They presented approach MD treatment-refractory In side. venous pancreatic advanced Cancer the to anatomical Michael patients which arterial our SITC circumvent PERIO-XX from a groundbreaking TriSalus enrolling Infusion the feasibility Center, Phase receiving I single-agent SD-XXX adenocarcinoma. The on and data from System, PERIO-XX, with safety at Dr. utilizes our retrograde addition the

Immunologic effects way PERIO-XX by encouraged or Grade other indicates the and events in biopsy specimens, and There have the these subjects will biology investigating. dose consistent treatment-related signings those we serious level. the metastasis delivery the treated we suggesting TLRX in success are live X no organs. pancreas are and X with into the adverse In indications data tumor study at SD-XXX been liver from X optimistic summary, Phase I pave consistency metastasis effective observed lowest data, the in pancreas melanoma both for and are that uveal specimens

are innovative delivery now experience for PERIO locally follow-up our early pass we eagerly back Additionally, adenocarcinoma the in to technology due employed. And further about I'll advanced clinical and Mary the We floor enrollment to which studies. anticipate closing holds trial, in the excited pancreatic remarks. the promise being

Mary Szela

future our Dr. continue Thank during both of programs, business, and to you the for delighted advance the we've progress Katz are made call in which PERIO achievements and you, warm At to our and TriNav TriSalus, all quarter, shaping exciting participating in a company. clinical today. meaningful welcome of our expanding share we're to an our

questions for have. you that, any may open With the I'll floor

your and are insights us. to Your valuable invest

Operator

question from of first Jason McCarthy our Group. And Maxim Instructions] comes [Operator

Unknown Analyst

Chad on for Jason.

response be in you see survival do stage And what of need tumors? overall So to to extension any liver and advance meaningful life? what you would a quality in later program? And to a think

James Young

nice answer to over Chad, you, Mary. Jim Thank and this to Young. is from pass I'm hear to going that you. It's

Mary Szela

question it's you Steven, to Actually, to. for respond a want to in? I probably think jump better Steven

Steven Katz

Mary. Yes, do be This, liver melanoma course, I'd taking so, happy uveal vary metastasis. will by indication to of

and early that very interested PERIO in the As I safety the first an profile we're foremost, we're data. think, example, in seeing

that that, DNA a signals, think circulating going program then critical to provides believe survival useful I of a forward. in tumor any And terms readout activity. a that, as efficacy to that as a survival measurement backdrop is longer-term biologic we're we overall early beyond very as as using disease beyond of be progression-free of outcome. measurement endpoint, then control and optimistic regulatory And of about of a then, course, moving

Unknown Analyst

Great.

uveal the a is melanoma And in for be first and proof-of-concept for registration? arm combo. it the may it sufficient unmet Is need so open-label II given the study possible single mets Phase

Steven Katz

for ultimately for using precedent an study needed that is X-arm believe approval, study openness we approval. that for with There We full ultimately would believe for a study be single-arm be required. a X-arm a full the agency will accelerated approval, a but

Unknown Analyst

II? encouraging, in cancer, data Phase then And study SITC early, albeit would outcome pancreatic move it. Phase be Got what at a in the meaningful in very that I a to does to

Steven Katz

a a endpoint believe II. clinical survival intrahepatic that Phase would forward to the signal into uveal, programs moving for like we a Similar meaningful progression-free be very to provide

conventional may One at set of things biologic RECIST that assessment from the the activity these learned full criteria capture the particularly X.X data, we've the data of presented SITC in organs. response not is like that immunotherapy

at provides, disease And comprehensive so assessment and clinical very think, responses survival, captures which progression-free durable biologic control, a activity. meaningful both we looking and of

that to So in meaningful toward X X we're looking survival months something very excess as that progression-free would in disease. of be

Unknown Analyst

to SD-XXX progress of sort Avastin in liver moving and first-line guess, I the the then of checkpoint. and Does you're And to a is the using potential to move What change use checkpoint. docs since patient impact wanting it. liver narrative? Got they combination another not SD-XXX of lastly, Tecentriq that in cancer with cancer,

Steven Katz

potential we has We it hope and so, do to hope that. the

HCC, we're For line second right on and focused now, beyond.

SD-XXX the believe has and biologic address addition the doing line checkpoint on failure. in in directly of Tecentriq to that So the we the based the at And that Avastin or immunologic reported regard. SITC, impact data for we're what immunologic reasons potential doesn't first reasons necessarily

generate failure So that the there, support and in or that we rationale and using patients hope the this. is medical immunotherapy data oncologists to we're hopeful see data to additional for will SD-XXX checkpoint agree

Operator

next Justin BTIG. comes Zelin of our from And question

Justin Zelin

Congrats ask PERIO Dr. promising at Katz. here progress here. the on I'd the on SITC. data like to Congrats

landscape your Just fitting uveal you wanted to this metastatic how hear in on melanoma? see the view the in of treatment

Steven Katz

know, Thanks question, Right limited agent all Stage we one for Justin. the type. patients, approved which we IV now, melanoma by for have uveal HLA KIMMTRAK, as is

don't express need medical patients for HLA certainly an haplotype. unmet there's that So that

profile it potential nivolumab and believe progress patients survival X% need presented application and We if was could at metastases. KIMMTRAK, well disease for liver for that the of X very really grade there. X the who optimal beyond progression-free opportunity for SD-XXX line that, melanoma for compelling for see patients the for continue addition following receiving there's it serious safety adverse SITC, and So those and in initial offer those event treatment. places rate, therapeutic treatment-related uveal with very overall control that to play there's And second where landscape a think to the And dose, therapeutic in the patients. we we rate the survival reported as out at

Justin Zelin

Excellent. on provide to indications data some just in thoughts your tumor potential might read-through solid this And other organs? maybe some of how other

Steven Katz

we indications, question across because targeting deeply protein, that readouts all the TLRX indications. That's immunologic We're present great that we that signals same in fact, Toll-like liver locations. receptor which same hopeful We're in and something different and clinical tumor X see think are a and or the will, we very about. metastasis similar hopeful all liver is across primary

In and hope presented that pancreas types. the another from across data pancreatic and early seeing at addition in that the PERIO-XX that SITC that set locally to immune that indications the adenocarcinoma and with liver early the see we'll are we so pancreas, multiple trial we consistent data one indicates disease actually are continue to the signals the us resonance gives advanced

Operator

remarks. I I'm like Mary would questions turn showing you. for time. to Szela no back further closing Thank to this it at

Mary Szela

our us you today. you Thank inaugural of TriSalus I you, Thank for company. Sciences. to all evident call the it joining to of progress and interest, everyone, Life earnings We your excitement appreciate hope at about sincerely the listen for taking our to time was

Operator

may now Thank today's you This conference you and disconnect. concludes for call. participating,

TriSalus Life Sciences (TLSI) 14 Nov 232023 Q3 Earnings call transcript