TLSI - Earnings call transcript Q2 2024 | TriSalus Life Sciences, Inc.

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Operator

Good morning, and welcome to TriSalus Science Second Quarter 2024 Earnings Conference Call. [Operator Instructions] 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 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; Dr. President, and Vice Senior Kim, Interventional Dr. Radiology; Alex this released ended financial Katz, XX, Chief for TriSalus Officer. Earlier Medical quarter Steven results morning, the XXXX. June second available A TriSalus' release the copy is of website. press on

be our These differ I and would in our and risk filings our remind we based Before we materially. subject additional the details. making and to factors like Mary. statements beliefs. begin, forward-looking expectations uncertainties, may Please are for you see actual to with the SEC that results will statements I'll that, current call risks on certain to over And turn

Mary Szela

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

the a in one force med quarter we United of of to permanent companies and technology sales compared the expansion growth. for reimbursement, indications. Starting quarter key priorities This significant impressive our status This liver advancing in and our and marking provide made compelling States, updates revenues XX% fastest-growing consecutive driven specific growth pancreatic second the TriNav growth last achieve over year. another second our drug PEDD thrilled clinical growth. XX% quarter continued revenue therapeutic of our the on delivery technology, the strategic of investigational meloid to and discuss data the to the performance, of our reinforces as report I'm substantial highlights quarter, tech robust pioneering and by of in progress quarter we'll promising our with Today,

diffuse a the demonstrated patient and medical and the impact This safety these of clinical and in complex treatment complex outcomes and the of populations one study not these of hospitals sites explore to program embolization across X particularly of from complex comprehensive investigator-initiated large focusing liver General TriNav and impact encompasses investigate health aims of when and clinical our of of innovative emerged DELIVER central patients. series tumors improved new theme Sarasot will program trials program U.S. This and technology A designed with and with the burden multifocal the Hospital, previous to patient interventional complex patient highlight China's the achieved discuss has complex disease delivery diffuse via a complex clinical to program of access numerous enabling liver. across clinical outcome complex amolization centimeters are This or sites in the type in institutions diverse comorbidities, States, TriNav wide large combination to define mechanisms Kim to of in enhance community on the tumor enhanced series multiple further is and TriNav dysfunction, and throughout expect TriNav sicker, who tissue and United population to the normal benefit TriNav therapy, of patients. Essentially, of of clinical otherwise tumors is goal planning and our enhanced compared goiter. lesions, higher treatment the which Dr. communities needs use potential the given and on we're including value care safety clinical inherent outcome tumors, in use bland high size, study patient the as hospital TriNav system, economic this collection. the will trials of types hypervascular populations. delivered through the research success broad complex gather to evidence sparing initiative Camacho procedures. We Juan to work of may economic across the those and shared, of competing investigator-initiated involving the system, will range with technology Alex patients benefits unmet numerous TriNav via resistant further launch therapeutic embolization these data engaging using therapies supporting case disseminate the DELIVER data the refractory using challenges recent therapies. The multinodular treat efficacy system following: we be the technology, As highlighted the named population we for candidates patient using Later significant Dr. technology real-world and patient liver. In bilobal burden spectrum difficult-to-treat more demonstrate involving efficacy actively A short, in transarterial overcome research in with the in demonstrate study. for a research the call, clinical approaches to and patients the treating cancers. radio to of And significant previously transarterial be a or and embolization our radiology based chemo to various

trials to our for Disease, aims the program PROTECT clinical soon Retrograde of demonstrate Embolization Thyroid expect Enabled with to the benefits under the approach Pressure Therapy this first of of surgery. Occlusive initiate investigator-initiated We or which Control called versus

TriNav anatomically include neuroendocrine with We for stands of system complex for to anatomically deliver metastasis and liver to [indiscernible], with for enhancements, YXX liver complex, systemic also patients integrating embolization colorectal patients which and therapeutic in therapy intend studies tumors. the

safety with liver for on of during in the TriNav plus liver is sarcoma colorectal spare. study to pressurized overall second the the liver centricity complex enhancement, for it chemotherapy clinical heard voices clinical and tumors. And our neuroendocrine improve throughout tumors. the with all system development the process. and patient and This complex trials, redistribution trial ensuring are metastases patient with the enhancements. patients emphasize includes of and This stands and education experience therapeutic embolic aiming patients, anatomically reducing therapy the system is TriNav investigation CTAs improving their for complex called We procedure. systemic for PRECISE It on burden next of embolization stands anatomically focuses for chemoembolization The benefits patients study

enable effects treated sparing embolization may tissue previously. have be with technology and patients been safety our not who to eligible of the Importantly,

we complement clinical our data real-world we us practice. and allow our Additionally, update to studies performs believe ensure understand these technology clinical to will everyday in how evidence our

We complex analytics striving patients will serve. DELIVER ultimately program within real-world our to impact generate life-changing sets the to intravascular care the we our treatment from the data deliver mechanical exemplifies conditions data patients of treatment tumors patients transforming benign and leverage or similar with a commitment procedures advanced approach. Overall, insights to for evidence to of barriers, undergoing solid

PERIO-XX Phase metastases initiate for clinical the this the PERIO-XX, will pancreatic share PROTECT Dr. for for year, Regarding PERIO-XX, summarize turn Alex our the Stephen next pipeline, our PERIO-XX, clinical with to end later I development the our full Officer, Phase to as plan full and the TriNav Vice I system. I'll well and our trial cancer. goiter steps intrahepatic Katz, initiation of trial year of to and briefly Medical as results the Chief Dr. call of Large of Radiology in our the system hepatocellular liver we combination Phase in President TriNav locally launch cholangiocarcinoma melanoma our have results Senior the details Kim, uveal advanced our Interventional PERIO-XX and of trial provide inform cancer. further then multimodular which we'll At on of I results of clinical in share clinical

our operational pleased strategy. I our pipeline, and by growth, against our saying, company our strengthen to in with to over and XX% the it over to hand line I to remain on foundation. top our conclude company's progress advance you. confident want we're track execute objectives We over to ability Alex, Before building revenue Alex, achieve

Unknown Executive

with both about new with the developed for procedure TriNav undergo speak including emerging TAE Thank and comorbidities, you, Mary. is TAE of registry or standard efficacy current safety our of [indiscernible] experience I The patients for injury. you device. an the to realization treat excited am being care benign real-world of for is or this which are evaluating study, associated to to hypothyroidism of performing treatment orders. significant and surgery the nerve radiation thyroid assessing to disease

of that treatment a manuscript died any Based events procedures safety directly early the TriNav itself do PEDD of describe XX,XXX which vasculature. that performed the will reduce resides. Dr. TAE which it the significantly efficacy Camacho, this PAE eliminate the to for and disease on PEDD the catheterize TAE standard risks, benign we enthusiasm TriNav initial the the to adverse interventional the as stroke, in the thyroid eliminates may TAE TAE catheterization mentioned over rationale where cerebral arteries, system risk need mechanistic has Mary thyroidectomy for has the so process. data, believe stroke of to Camacho the artery without performing care currently inferior be currently radiology the Dr. in the introduced potential this as of the with muted from treatment and which is developing the with communicate system who and believe of the undergo embolization the has cerebral only patients the currently XX for disease or for We significantly superior While an thyroid and of PEDD with become a effect TAE procedure risk PEDD great in has who reduce date stroke earlier, carries with majority of community. experience. thyroid to risk approach or performed these transformed not

to this speak this for about Stephen Officer, large application to our PERIO population. now I to Medical enthusiastic Chief efficacy deliver like better Katz, are patient over trial. about We our the clinical and potential turn safety the to Dr. call would to

Steven Katz

Thank you, Alex.

receptor liver improve be delivery drug duct X DNA results nolitolimod meeting. cancer typically the into survival we at largely focused hepatocellular patients on systemic and tolerable and pancreatic immune could responses, for we or opened have tumors disease, liver the EDD adenocarcinoma of tumors toll-like with I immune reported X cell advanced X patients and pressure on ] signals inhibitors or data directly eliminate primary presentation both depletion promoting overcome or HCC, to early circulating and primary cells advanced fall, patients. The and one, PERIO-XX metastasis explore clinical or reported the CT remains intrahepatic safety largely checkpoint our PERIO-XX on suppressive pancreatic programs what the know, at historically combination PERIO-XX Nolitolomad or to with recently via other and or the underlying the with and suppressor cohorts. XX The challenges of PERIO-XX of control refractory including PERIO-XX these study of to cancer final liver associated method, reported you data agonists and MD levels the and for stimulation PEDD highlighted to delivery, DNA complete dose in to who via was patients, carcinoma, safety the we highlight evidence by I across patients As investigators enrolled Two, cancer combined giving bio Anderson. derived via adenocarcinoma cholangiocarcinoma pancreatic focused end and immune immune inhibition locally liver Phase trials nelitolimod could disease initial tumor treatment myeloid ASCO and PERIO-XX three, delivering at the recruitment; or were agents. Last liver the refractory we profile, enabled plan when into [indiscernible] T cancer. pretreated patients encouraging with and SITC objectives this tolerability nolitolimod patient with I for or duct would MDSC from hypotheses: and in studying stimulators. cells, outcomes a to initial in The metastases, study PEDD given to broader trials. locally melanoma PERIO-XX Phase test systemic report of We checkpoint related cirrhosis. pancreatic often liver open including [ patients uveal TLR liver Anderson while SITC in signals bile Phase metastases liver aligned is PDD the with considered MD patients year. The the results XXXX innate

disease immunotherapeutics to of liver cancer advanced the HCC [indiscernible]. And X, the PERIO-XX similar MDSC to while milligrams and efficacy event into systemic X walk and the overall doses through Overall, a safety or T reports safety. from profile recruitment rate cell along with the X primary and treatment-related carcinoma. uveal patients grade disease begin adenocarcinoma the with of we me had of melanoma and activation. was We'll which using we and and PERIO-XX pancreatic PEDD. XX%, Let higher The the inhibitor results. We cellular the patients. the with study, patients. X you a data cholangiocarcinoma were cold study, in via typically a for the of depletion of deliver X/X immunologically also immune pancreas potential believe with in with, monitoring had with evidence in this objective prior Approximately with of further evidence the aligned tumors observed was pleased tested patients and We of [ X present and liver PEDD doublet nelitolimad supports underlying and given have reports immune of not the intrahepatic when of cholangiocarcinoma combination nivolumab ipilimumab checkpoint remainder evidence control ] adverse

enrollment, with Importantly, We niletolimad, of had or of was checkpoint did any clinical XX% evidence prior lines using population. combined at patients indicating a nelecolamonotherapy, see or that received not more activity the pembrolizumab. therapy, of overall X inhibition for very this single-agent difficult-to-treat

overall disease an nilitolimad control response would to previously typically rate treated who of XX patients. in was cholangiocarcinoma the patients combination expect XX% XX% we nivo, and historically, of a XX% in and received rate XX%, ipi via with with in rate the PEDD However, response and

median in who remaining response alive the of X group months. had the X-milligram and nelitolimod, received X disease beyond survival still complete X X ipi/nivo patients patients X X overall and combination including Within months with response. The is dose on-treatment group patients response, partial a XX with evolving as in for best all control of

patients, While safety of outcomes with in along The HCC in the with therefore, doublet proceed to and plans are update patients and in consider from an PERIO-XX, investigator-initiated we this Phase results the provide on or cholangiocarcinoma pleased effects, PERIO-XX, There we studies or and our these nolitolimad pleased the data and immunologic to encouraging this be for we and on tariff radioembolization the a year. in to highlights consistency number of patients too and checkpoint chemoembolization continue for limited in may future. Despite for combination interest to with limited further PERIO-XX to the development was proceed, quarter. will do that, investigator our is in call who cohort. we II [ With would Sean the transarterial us to by exploring these intend regimen. with I in transarterial indications financial in TACE not like of to ] we the see Murphy, end Officer; Financial provide over the Chief turn the decision will

Sean Murphy

morning, that results Good June Steven. XX, thank in TriSalus am to achieved XXXX. outstanding I and the second pleased quarter everyone, you, report ended that

a first increase reflecting the X U.S., This the of in TriNav sales XXXX. Revenue Our revenue the to solely compared of over same first compound XXXX. TriSalus account track driven since the account compared grown a at record our strong XXXX. to as by million XX.X highest In of product has of XXXX. quarterly a XXXX the per XX% $X.X the that hospital in which growth success the X, our to annualized period XX% achievement the on quarter in we reached reached units quarter. months the the has captured new growth. of the representing company device in quarter, XX% months X represents account second Slide accounts, XX launch and in compared of million, $XX.X units demonstrates XX.X reached of per in sales the utilization illustrated company's second rate history growth in

We nelotolemine segment positive EBITDA costs XXXX. of continue and excluding expected to clinical is the late growth in XXXX the over forecast to approach XX% business,

as a increased of XX% profile continued strong XX%, attributable to XXXX very growth positioned be the margin other report of over to factory are proud can and XXXX. This are for compared the operating our with Of next years and can respectively, Westminister, investment. note, long facility capital profile XX% second in minimal our Colorado batch in manufacturing volumes, XXXX quarter efficiencies. support We in in X improved gross XX%year-to-date to favorable term yields margin well the we and

respectively, the for investments the our development, $XX.X million Regarding and of first totaled quarter XX% decreases expenses XXXX. compared in in research representing XX%, $X.X XXXX, and to of second periods and and million, same the half

our the decrease from continue data over balance expect we follow-up we our in call, patient of analyze trials. clinical finish quarter noted costs XXXX As to to and first as the

closely and a second X of strategy. $XX.X to XXXX. These and to investment the Our same sales specialists. our compared are expansion and months XX million, X quarter XXXX, to our XX% XXXX force support and level in XX% the current investments we at tied of total respectively, in our the $X ongoing period of representing representatives first increase of sales beginning clinical XX growth the invested and million In in representatives of marketing of continue from increases to

$X.X and continued to we our team the in in in the and the the will representatives General in totaled and the clinical adding X compared of expenses personnel be quarter our an decrease XX million of uptake first accounts. drive year, representing specialists period of Over XX% to $X first of administrative months XXXX. months in a balance the of and second increase to XXXX, quarter high million same additional the second in X% X

second more state increases compared quarters, levels to becoming a last several spending which The public larger quarter of to had XXXX. due we represents steady a in company the August

Our months $XX.X totaled and the to for X quarter million and second losses the of $XX.X months quarter second of $XX.X for the million million, XXXX. of XXXX respectively, the losses in operating and $X.X first compared X first million for

were and support attributable As margins mentioned and costs. improvements strategy, marketing partially noted. the gross by previously sales offset in our XXXX research sales, improved to decreased earlier, expenses to development increased and lower higher losses as can growth be These

of publicly our sheet, to me to the reduce June exchange outstanding. closing were subject impact move operations. With we XX% in potential in company achievement announcement of with I that X, of more of up private April warrants balance $XX closed at On the in $XX an traded the to with dilutive July flexibility warrants financing for financing over warrants thresholds. exchange a revenue X issued to the speak financing, of we our structure, capital our the common The Before let terms at additional common in for we and certain XX% aggregate shares the credit simplify offer in stock Under facility X.X was these shares borrowed regard for to future tranches of warrants warrant. of and million our million the each tendered transaction million of exchange an purpose our option, this X.X and of negotiating provide we available to the and have X million and the closed debt OrbiMed. agreement,

end to to, the spoke equivalents. the our current the sources runway hand Moving sheet. We financing quarter to ended balance of cash along assuming the on fund $XX.X full is The with cash other through existing we borrow million sufficient the cash of liquidity provide of expected million just $XX XXXX. and I operation to with and cash

forecast report turn we XXXX. And operational forward, top Looking growth costs, to continue in that the excluding positive to XXXX our to call With line to over late closing Nelatolamine to efficiency, revenue now for am EBITDA commitment XX%. I'll we I Mary excited remarks. revenue approach and expect growth back

Mary Szela

I'm mission. strategy may strides unwavering open bolstering want to I questions our Their and team and TriNav all participating the to to welcome programs. in you, we a the fronts. With and multiple patients, our are TriSalus significant propelled clinical you any made we've forward pleased has thrilled call brief, the today. thank have. perio Thank company share In at commitment our their business for warm TriSalus advancing to floor the Sean, in that, on answer to our performance to

and in and our your inquiries are company interest valued. perspectives Your genuinely

Operator

comes from Walsh first JonesTrading. [Operator the question of Justin Instructions] line Our from

Justin Walsh

you're terms the I'm you in patients patient progress. at wondering context of there's any the DELIVER numbers of can for types provide program. on if your looking Congrats in complex

Mary Szela

Do I'll want it hand to Steven? Well, you over that, address to Steven.

Steven Katz

Mary. to do Yes, Happy so.

thyroid early year. to program. get up in to estimate program our So the forward with could in we patients. the the we're that And PROTECT corner the that data the initial market DELIVER We going from to seeing multi-module total addressable patient population that patients be goiter, next XX,XXX early addressing look program

also cancer liver that colorectal a metastasis We segment of the market. consider patient

are In as carcinoma addition, to hepatocellular patients complex well.

Justin Walsh

indications? in it. results for follow-up Got PERIO-XX guys one and you in to move quick are I'm looking And me. what those forward convince to PERIO-XX you the for wondering

Mary Szela

Sure. a that. I'll take Justin. good question, That's really

the We define I into what we One went we're of we the an to and of wanted regulatory we be a ourselves. effect. a we was wide Phase and that where be wanted that a when a things to in as our array ultimately, significant market very a mission fund doing large had we trials, indication program position smaller would knew company, where potentially could that we have program straightforward have to a could treatment

So it's moving and really favorable criteria that we're the based data as we to but the clinical we'll in trials those see look the a we forward, to across be going at the decision really in parameters quarter. on the data, pleased that fourth see announce

Operator

next the Plovanic of line Canaccord. Our from comes Bill from question

Unknown Analyst

on It's wanted today. start the updates the and gave you this John just the trials on to Congrats for Bill perio quarter. on morning. I

For this down not really do and and the future compelling, then the this and ], PERIO-XX, both Would trials? ICC limitations, this you HCC X resource opportunities advance data and is line? PERIO-XX look if to just would both further. the pursuing resources if go in have pursue you of And so are further [ the sets you because pursue and

Mary Szela

Great question.

the hit on head. you think I the nail

out at I we about Steven Anderson, MD think criteria that incredibly investigator is and were what And Javle we're it's lead enthusiastic that trying it. Dr. have looking PERIO-XX to and ability of in comment. the our to actually do really our fund. data who is is I'll

resources, we to financial want do forward clearly decision PERIO-XX. so have If And would really you that's comment? on made. we the Steven, we move the

Steven Katz

PERIO-XX quite overall were Absolutely. Yes, the data encouraging.

consistent liver early we're Nelitolimod we The is we've grade the cirrhosis. immune seeing notable effects very data that that Firstly, programs. with patients adverse with in have because disease, in with seeing as the these other from particular, the event adenocarcinoma see rate what a we the consistent been including pancreatic did with were XX%, are or was very which underlying treatment-related X the safety X the summary, signals pretreated some patients, in data we also cholangiocarcinoma including patients the complete response PERIO-XX cholangiocarcinoma saw encouraging line in what in in survival HCC fifth Ubomelanoma see early noted the and did and patients. trial. And heavily then

were the as decisions overall but So some data effectively. strategic we're most encouraging, allocate short in noted, Mary term, the our resources to making

Mary Szela

And us that be, patient one seen to small favorable. the to XX a challenge John, I'll the we the and come of challenge X,XXX per which on It's with the at make The PERIO, and answer that The of this indication going quite and for question roughly ]. second have very released market. back with we PERIO-XX just year. [ today, you've is which is I year. we'll some know patients have it's end data decision

So against we're significant weighing more PERIO-XX going indication. a be that to which much and much is larger

the in factors our quarter. decision into So will those obviously, come fourth all

Unknown Analyst

by towards Protect. more that you may have this to right? this follow-up on be in And Large And a just there. the same Is launching on TriNav. X itself, I embolization, as coiled end that Is then great. TriNav just would not or just of around radioembolization, color just as of want it's I just the modular just regular ASP a the year. think the would Great. questions -- TriNav thyroid opportunity be blend. the in said confirm

Mary Szela

Sure.

to same the exact Large, price. it's going TriNav For be

it Alex, so going be a you I want to secondly, So And would if it's is some that. priced be larger identically. size, comments just make to don't further on they know, vessel [indiscernible].

Unknown Executive

Sure, happy to.

the So yes, going choice. bland embolization radiologist particles are these be to interventional of using

attached currently are land are uterine just or oligos the internalizations chemotherapy through with how that delivered fiber are So these radiation done to particles [indiscernible]. to

Operator

Thank you. questions. closing like this remarks. to conference to further Mary turn for I'm back Zelle showing over time, no the At I would

Mary Szela

again, call active appreciate the you. following for We the really today. and your you of everyone, your Thank joining company. Thank interest

Operator

This concludes Thank for you call. conference participating. today's

now may disconnect. You

TriSalus Life Sciences (TLSI) 15 Aug 242024 Q2 Earnings call transcript