DCTH - Earnings call 3 2023 | Delcath Systems, Inc.

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Operator

Good day, and welcome to the Delcath Systems Reports Third Quarter Fiscal Year 2023 Financial Results. [Operator Instructions] Please note this event is being recorded.

I would now like to turn the conference over to David Hoffman, General Counsel. Please go ahead, sir.

David Hoffman

Thank you. to call. XXXX welcome and quarter again, update business once Delcath third Systems earnings And on call Finance; me Chief Officer. Pennell, Manager, With the Oncology; Medical Senior Officer; Chief Interventional Purpura, Vice Sandra Officer; Executive and President Chief Vukovic, of Vojo Kevin John General are Muir, the Gerard Operating Michel,

Private Act to like statement by forward-looking made XXXX. to pursuant call described is made harbor statements safe for Reform the I'd reading the Securities in statements All the the of begin This harbor Litigation safe statement. this of Securities on the the historical may be XXXX of call Section the of of of XXE Exchange within statements Act facts, and with the Section Act Securities of exception considered XXXX. meaning XXA forward-looking

expectations statements to statements these that from differ assurance reflected the those have prove no makes may or company are forward-looking and it such correct. implied and forward-looking due expectations that will materially various expressed been risks to believes in uncertainties. assumptions results reasonable, Actual Although in

contained XX-Q from other those filed XX-K, Form For which to Commission. could company's with Exchange forward-looking as detailed to on reports Form report a the the subsequently on time reports as that please quarterly or expressed time see cause the and in statements, in implied in uncertainties, files risks from those results risk differ annual in actual factors of such well discussion company Securities the and

circumstances. subsequent are in any or to made supplement call. the call update as events obligation reflect included do knowledge, statements of statements any We this to forward-looking forward-looking undertake Any this only date not of or

over please I would call to Michel. Gerard Gerard, like proceed. Now turn to the

Gerard Michel

on potential commercial now of for today. FDA sites approval of August January. outreach and with anticipated have our on uveal been launch, for Since metastatic treating in which everyone, team preparation for HEPZATO joining you, we melanoma, XX building commercial Thank focused patients the KIT is

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been In HEPZATO we stated motivation KIT uveal and radiology KIT both treating medical metastatic with to HEPZATO FDA to interventional incorporate approval, oncologists by have and melanoma. the encouraged their commitment practices patients into communities,

focused these been teams. more conjunction While to we each interest to at primarily a HEPZATO train identify subset sites, interventional throughout target working sites, achieve planned oncologists the treatment the with we are our have fielding are ensure of medical the from local sites that and we on KIT our targets with radiologists we year. In than of XX activation

the training we each through to hospital trained. are HEPZATO at Duke traditional Cancer have and get started They product. addition treatment of University committees, teams formulary which the availability KIT can and the approved Tennessee, we XX site, the value in fully analysis EAP treating hospitals. Currently, of In upon Moffitt are Center, we X patients and process start to commercial sites, also that have working University commercial various

are their completed guidance obtained. Clinic, X once under of now that we the have first Committee commercial a University approvals proctor Mayo addition, treatment and available Ohio formulary a In and have steps the Value further commercial necessary sites, is University Thomas Jefferson, product Stanford Analysis conduct and State to

at and a proctor the a of successful Analysis January, first have of In case various in sites we November another contingent completion treat or total, John's, sites, the Beyond Providence preceptorships by expect for sites, least case ] General completed Mass UCLA, those to scheduling currently commercial [ the have the the required on X X Committee and will Hospital, end December. XX St. that Value Piedmont training scheduled processes. team

first Given the be of treating the mentioned to proctored XX the first community sites approvals, need don't the in I actively for be previously quarter. patients required case to and expect all the

and However, sites will centers based in XX of to the XXXX. date, end on quarter, of I that the quarter first second the treating interest progress X least end the confident by active at am by achieve treatment and we sometime XX

end and approximately per per at We month. X out expect X per at site treatments approximately to the start month year

meaningful that centers interventional HEPZATO melanoma is and for a Jefferson interventional currently procedure melanoma Since drug, patients an focused currently uveal offer oncologist not mentioned they liver-directed liver-directed KIT liver-directed therapies uveal thought-leader, University and number led centers treat infused as radiologist, therapy. leader liver-directed medical radiology a Thomas Orloff, by metastatic Eschelman, with are David Noteworthy a in of on an Marlana currently we therapy. include patients

noteworthy Thomas Yan Jefferson of with melanoma thought-leader in [indiscernible] and metastatic medical Dronca radiologist, oncologists, interventional Mayo by With far [indiscernible]. and UCLA. country. number the Other centers Ritchie patients Clinic include oncologist Roxana Yiyi the and [indiscernible]. interventional treats largest Charles uveal of uveal medical oncologist melanoma and

investigator [indiscernible] interventional and with [indiscernible] Stanford principal Reddy FOCUS oncologist, medical the John Gloria Center and Huang. University Zagar radiologists, Sunil with Trial

Interventional deep has that of Since bringing complex on therapies Kevin have launching Delcath's require in hospital stakeholders Kevin commercial a experience approval, has Muir, of the made General multiple in setting. been Oncology organization. building point the members team Manager busy

MacLean, over teams from leading Scientific example, XX our of liver-based of years comes Director and Sales, interventional experience procedures Boston market. to bringing Zac new has in For new

centers. is while treating managers the will with that ensure goal networks served which liver-directed X oncologists approval process X KIT oncology comprised representative the referral of the oncologists regions. and guidance, manage will Under hospital of our trained a the of will of engage the U.S. managers. outside treating the procedure team The therapy team representative Zac's The HEPZATO procedure. liver-directed oncology community-based we performing supportive therapy the have to building within commercial medical divided and be and by a centers into Each

each treatment of goal clinical In by supported a ensuring in and and support patient will be safety the the outcomes. team teams addition, treatment with specialist who improving during patient preparation for will this

patient access, been applications consultants from ease Kevin's obtain C-code, required to and with To CMS. has the working to NTAP market the submit J-Code access team

we codes of Given KIT, payments and HEPZATO anticipate to add-on the all nature be granted.

We including the patients planning, HEPZATO patient numerous are in final authorization. aspects to designing hospitals designed of of access called assist program in a stages Access, treatment KIT prior and

service hub We significant with design diseases well-established oncology ultra-orphan manage experience working designed and are a and both in program. this to with

utilizing Delcath's HEPZATO CHEMOSAT PHP and to for with KIT patients an add external important We or delivered to continue treatment growing evidence liver-dominant procedure, body melphalan is internal by the whether support a of efforts to melanoma. that both option uveal the

a from study Hospital X retrospective Germany or of uveal announced the CHEMOSAT CHEMOSAT the percutaneous investigator multiple SIRT patients internal versus metastatic from perfusion liver-dominant Tübingen, Journal the independent of radiation in recently results selective compared publication hepatic liver-directed and with University SIRT We The from study of published of treatments cycles comparative melanoma. of of therapies, Cancers. X

impact CHEMOSAT regression Median with overall XX patients and a p-value with survival to patients with XX hazard patient significant interval XXX difference SIRT of of results liver X.XXX. CHEMOSAT. and was ratio X.XX for adjusted The XXX XX% X.XX outcomes of between An and a on X.XX of days for treated days there treating a was model, [indiscernible] SIRT treated associated confidence the CHEMOSAT. the the with clearly survival overall metastases and positive demonstrate

liver-directed Phase reminder, The investigators immunotherapy the effect the ongoing patients trial adding initiative a in Japan randomized of investigator to mid-XXXX. XX trial, and therapy. an the As the Europe, CHEMOSAT to fully is there in enrolled II the of has trial XX be enrolled expect trial evaluating planned

treatment Ipilimumab with CHEMOSAT defined The and trial by treatment primary objective to X survival determine of with immunotherapy versus is CHEMOSAT nivolumab of efficacy progression-free of at the year. the combination alone,

September An objectives Secondary and the without monitoring response resulted recommending rate. overall analysis overall futility in of independent committee, survival continuation study interim data modification. in the include the conducted

in XXXX. As mentioned our we earlier, since start to expect sales January commercial now commercializing

process been quickly feedback between utilized patients the of and of and confidence care have approval increase progress after initiating of for melanoma number The that approval institutions. will numerous metastatic liver-directed trained therapy launch. time gives treating and us date KIT become launch the the centers HEPZATO uveal to to We formulary standard the

our will I to to some on Sandra details share over Sandra? position. the financial call hand now

Sandra Pennell

you, was approximately funding Thank operations and $XX.X ended X exercise. Gerard. million part months $X.X The in as tranche received warrant We QX to million in the the with used Cash cash. of year. in is of increase quarter the due for third first in cash the the $XX.X million

are issuable tranche $XX another $X fund shares capital. exercised the without stock. equity Specifically, a million $XX as price the million strike the additional should common million warrants of issue tranche for having until $X.X the stock million equivalent in of fee common equivalents of were part X.X The sufficient to be warrants company of at for to

$X.X The tranche was the Current of fee for the fully million quarterly XX.X million basis. to diluted Revenue in months achieving shares million in million XXXX. result revenue. outstanding, XXXX, X on our $X.X $XX $XX XX, from gross of proceeds XX.X million upon X September would a compared the XX, warrants September million and sales CHEMOSAT ended company months for ended

other related The ended months to million requests advance in for were FDA of increase months ended of XX million approval expenses to inspection R&D this X the X the the to due September HEPZATO. and XXXX. For XX, compared activities $X.X year, $X.X their September is

due the commercial XXXX, have $X.X $X.X For million and the XX, XXXX, X to compared launch. prepare to million administrative period for months selling, in increased same activities from general ended September expenses to to

earnings you line business for our concludes and Can for to ask I'd open update. check questions? Q&A. That operator And the please the

Operator

Genuity. Our [Operator with Maughan comes question from Instructions] Bill Canaccord first

William Maughan

So I questions. X have

getting through about availability running being approvals. sites product So go and Committee sites you and to Analysis last Value talked hurdles and up the

Delcath Or that is of Value hospital how process? approval? words, those much outcome Committee certain how processes. it internal is the sort Or that a process? is in how On active any the there an that check-the-box is -- operation? generally other And sites uncertainty Analysis In of approvals, is in

see you how or you do Second post those be along are see question addressable is, an to simply how used patients -- [indiscernible] far being HEPZATO too market? this

Gerard Michel

Yes. All right.

as sites. Let some to can you. forward to the a place that but Kevin, certainly could go going you add this, the to color think we as probably you me have think, to Kevin from some in wouldn't you I support And -- aren't moving of no good support. company start I that far but think box, some hear cover the say But Kevin, add of first but would David, some extent and this, give check we color I there. and the lot do we're presenting and say, but confident sites I There's some gone, with that the Bill, color? color to to also are I them can extent. to some have add And support aggressively we where days question, long

Kevin Muir

It's Gerard, And far we will Yes. we process from reimbursed. check get code you. they're -- will get It's the facility. procedure, thank for basically looking paid, each we a box. this if within formal

And to decision hospital of limited a its so then provide are on amount and a makes we itself. asked information

in Gerard for to feel been them. we've and the call it's feedback the in that's earlier And the if We mentioned see good. them forecast for of assisting to has beneficial the confident had coding this time with they're are -- up very point services, and coding that -- with to our kind hub facilities then the

the of out that by we'll of that will X January. mentioned, have perform confident procedures end we're that sites of the that XX them Gerard So

Gerard Michel

Is think but not of a this any, usually number We've meetings just have isn't haven't I meetings there already, yet these it's have meeting, fair to have correct? a geez, type to to -- reactions. happen we that Kevin, it's number these of And been going X say and started. that

Kevin Muir

been We've by point had communications each overwhelmed we've in hospital correct. with response had to the and that that time. the entirely It's this X-way we've

Value Analysis to we've As favor. if anticipate Gerard hospitals, and mentioned, we've made with most, back of and we Committee these that all, in coming presentations not our these the the had calls several of

Gerard Michel

some who will tebentafusp, be maybe, post And progressed. Now question, be. I your far too may Bill, in far are terms some are patients not the of think second answer gone, they too is

are want use I we believe liver-directed really to first a are in that sense. cases, some step you go the question many who certainly first. back, systemic should take out think oncologists There that first There others makes there is liver-directed if first. to

to not it's going be tebe going first. automatically everyone So to

benefit us, I whether because after with going treating with think the one getting tebentafusp. oncologists immuno-oncology from through we're to you to or pseudoprogression of agents. is you're points They make a progression treatments not can X that the tell recommend

it's of really going not. run know the with you tebe before or you whether too long risk So working

it So sense may us that with start from to rationale. make

say patients I'll seen we have The third thing is post teve.

seen patients patients for with and post that tebe So us we've tebe. coming first, applicable you've are seen

we you get with when go clearly, you're first. to liver patients of eventually us and we'll we So whether unfortunately going tebe number good efficacy have we a but quicker mix, think that us sound site life-limiting is of first. usually have fair it's the I still the to a But with those We argument not, go you get can if a a think think argument progressed. getting be metastases because organ on read a

Operator

question next Capital. Henry Scott ROTH comes The from with

Scott Henry

Just had questions. a couple of

as of out, thinking -- launch high do X that month, sense X I trying think you to moving think When about get know, I'm an How volume, to to are X Gerard. some because metrics average? trying less. per or more, per location sort of laid you about reference. as will X do about to you as Or you that far just will month, do First, as some a put that people do the think we a in obviously, just

Gerard Michel

Yes.

here's have. what think I we

really most get hope that sites get X we networks, there's knows. confident definitely moving, as X But X -- peak come think down, the be I doing maybe what out referral time we're do new recently get that to I some they months. have there And building every building thinking kind some it's week and the at are averaging, and might Before networks. we of do onboard, who that week. my least the X and is And really to doing I'm a there And sites share. X doing there'll average. those know, or the an to horizon. Eventually, a that's sites they over X get others started do need they're are referral be ones of it's out

Scott Henry

time expect Okay. Great. a how you number patient, cycle the And would utilization? per -- And average when much we between have? patient cycles would about think cycles of we how in about cycles think should

Gerard Michel

we the Well, saw in Trial. FOCUS

I you as know, was think, it X.X.

patients the the between cycles, of we're our -- Trial, up we kind to X So assuming go In for FOCUS own to purposes, modeling weeks allow was recommended. X. X

we've I U.S. some that think more setting other docs, seen capacity is in use settings, in Europe in what earlier the

waiting. weeks Some docs choose and to do do too quickly together at let's protocol then say X, watchful apart, perfectly. X the follow Others we

we're So I straight to do to wait. through. X subset guess going Others think are and a -- weeks go apart then X, my have is going to

a those to just wait risen blood we One level lose because that doctor withdrew thing I am will few won't not trial the is likely in certain lost in patients the their because of the setting extra that counts have to is the commercial them, appropriate we weeks. or retreat

I average, think -- it will go ahead. be on So

Scott Henry

launch, we about quarter day cycles quarter. expectations everyone of out So as quarter, for model depending they... it to the the think per think the X in we should come when cycles doesn't first obviously, when about as sounds It we like X per

Gerard Michel

some I treatment. cycles. to say Yes, we on right therapy. right surface then ending a mean TAM. point, of counting X. patients start treatment, average, we'll these It -- now, in of starting first or be were at site, number really the quarter, X. kind talking just scratching X patients out per a now just early when -- treatments we're the to we're on treatment cycle But focused in have month Yes on levels X And or terms the about because of I not a one At could

Scott Henry

that hospital, Okay. you should And this could procedure how how Gerard, hospital typical product? maybe just maybe with is What gets if about think for the the that? walk paid through and we

Gerard Michel

Yes.

of They're for doctor's will codes the CPT to we're for there They're CPT time. about set outpatient. patients the So a because of in set the put codes put payments, fee. X going for these in a components be to will going majority procedure outpatient of typical of hospital, a right? And to all facility talk for going be the

most component they that direct not to but Now it's be so J-code. itself, third But get doctors That salaries, in and a that's will KIT. eventually HEPZATO a incentive will be these reimbursement of reimbursement we C-code for do payment. with pass-through the on them, a are a care. And initially putting drug the for will

So plus the whatever them, we paid hospital charge would X%. be

that to or and particular pause there if of process detail there's any any like about. see that Let me part just you'd hear more

Scott Henry

that's into hospitals to of them utilize so these will X place, -- I sequence as there this? want that the necessary are start process? come good No, all is a codes think they that Or all

Gerard Michel

Yes.

-- they'll So the the codes use? a CPT J-code. Kevin, and board, let in the of work being do when initially going what -- to availability me then And of the codes on explain terms why when then you're portfolio you then comes a don't of C-code how

Kevin Muir

Yes.

So thanks, Gerard.

codes codes the procedure. are more that during than the nothing are describe CPT So what doing physicians

will the X go So procedure, for presented thing. hospital be they through do. when for to will Their -- hospital, code place time. then exercises will or CPT what or codes hospital these gone step Those doing. Physicians, they both codes to they the their the correctly They're ensure and adequately for ourselves are be our procedure, -- reimbursed do be they codes fully We've for there coding what do. the will going X they are be will match the same pay they go what in will the of the are them payment they if through this number The there's physicians. when them payments, comes to there and -- CMS X record a through back. and they partners that

that main sure there really Committee, when Analysis on it. lot Value of are come for down you And the soon go it's to usually the should the that transitional we So concerns C-code what's which but make actually CMS -- January. January earlier hearing called TPT, drag a X, part those are called in is shortly. is anticipate anticipate question of hearing pass-through We application, then hospital our a very codes on a And they or X the CPT on sometimes into in on C-code. done from Those the results This product. final from into effect the the back position.

So on as fee they mentioned, be Gerard a for that pass-through and top the get should, a payment that. of administration X% hospital

So in them at seems the move more time, point that than be to customers to the from again, hospitals -- to this reimbursement from talked adequate forward. we've for there

Operator

Next question Thibault with comes from BTIG. Marie

Sam Eiber

through This Maybe of Marie. some the on for is I on the the treatment Sam Eiber my can getting first question here CMOs. those progress use Congrats on with sites. work

I think it's call bit a longer earlier taking that caught I than the expected. your on comments

to going that's bottlenecks the additional on behind of or some work Just there? color wanted on maybe any get the scenes

Gerard Michel

Sure.

who So we to given labelers in for uses up for melphalan, go [indiscernible] all and won't CMOs series labels the set they situation details, while CMO more or acquisitions quite where and on we ended melphalan. various -- such. of we're with [indiscernible] in holds -- make to What like the CMO ANDA Italy. through directly we'd with Mylan a known work a we've the use the a for contract initially I up a of signed based that a

to prior labels tried work we'll post-approval it, it the naked saying, that up and we'll can we label Italy, to ship ourselves vials, to to anything on some approval accelerate us of and this. take ship have We make

very having these times. And contracted we're for small what your and -- them player unfortunately, difficulty this manufacturers, of moving is say are a lead getting we move nested basically, off generic since product here's they really to

I'm but which in end the a won't an the our a second write got run little this. Could is. really have got get into way time been of term. the to an calling full probably This generic where work that's to will Again, a unusual Now small shortly CMOs. situation. already we're using line the This carve-out label longer what or getting of bottom a We've of was be a Perhaps, the no product, to what in with and position smoother? after is order for at be day, even these batch, way And guess be large a batch. for we've we're there delivered it net problem us. first really ahead would check what

so We will forward. be supplied that And have wouldn't bottlenecks going anymore. well these

a But for we're it's where position never really a again, thing. fund our own in to ANDA type situation kind of of this

as lot situation. go of So kind we And a is slowdown And have making the we situation don't a at as live focus situation. going just have never any stock to supply sure or this with forward, to on robust out we a we're we're chain possible. --

Sam Eiber

quicker just you could check-the-box use [ Okay. VAC process that kind Maybe hear color sense. ] products do recognize the usually how I take? expect could I not How but Yes, we -- take approval there. the I a on just those to some it's here item, XX approvals X probably long to of it's mean I wondering bit other of that that take? long appreciate follow-up assume for makes VAC ] thoughts on my these here. added months? I questions. a [ all your

Gerard Michel

Yes.

oncologists else what's [ very this stent. ] this the infection think are is regular nothing this it forward to is a hospital-acquired This this patient And antibiotic our -- for meetings. champion well, push this and outside I is another radiologists and where like another product about happy unique for is scheduled individual medical not set. or there

color? repeating Kevin terms but is left is in out me, doing any further has anything there I'm I what what Kevin, told Now of or the here process

Kevin Muir

Committees. about you Value X throughout again, ultra-rare of lack care also add did is to little of to encouraging been it's a budgeted what too these question, color right mean, career, of we're right. And it's been has and for standard that of we X Analysis hospitals. But have I entire -- patients, the disease, of you're these my this kind it's the at months for No. some

kind the need moved recognize they X product that we're maybe in to we're so outside and for of we're and probably months, that and than of scenarios, the And X bringing that. shorter some months closer even

So it's been very committees. that from response encouraging the received we've from these

Sam Eiber

Okay. How just Really many the of proctor that could helpful. a that clarification U.S. do sites you expect question. Maybe essentially to you proctor have the cases in the do have?

Gerard Michel

Kevin?

Kevin Muir

Yes.

have right sites EAP my to requirements. at sites trial abbreviated list the of go. that Looking The now, X we training have the are ready focus rest

X, X. X, So that another be would X,

So we'll have some.

Gerard Michel

in of teams go, right? proctor [indiscernible], terms to ready it's Kevin,

Kevin Muir

Oh I the question. proctor sorry, Yes. misunderstood I'm team, yes.

Gerard Michel

we to happy And the slow, of It's going [indiscernible]. months, Europe than more of a fly we'll Yes. within another number it's teams have be a a have in proctor. but and teams one up going and X that's reasons to who and few or bit team, are X over

So that's to as up going probably -- well. teams we're European some relying on end

Operator

with The from Yale Laidlaw comes next Jen & question Company.

Yale Jen

the progress. couple just of quick ones. quick couple Congrats -- of a on A

-- the potentially you preparation year, of the end -- use that how of And over level of is -- how supply your terms next adequate your might launch next the for or do anticipated what the the year of subsequent beginning inventory beginning would -- by be? quarters? that be anticipated one in inventory the First -- think this

Gerard Michel

year's The to trying Okay. [indiscernible], I'll inventory the of I a question. got answer, is first worth least maintain at level, we're inventory.

looking think a once -- be I rolling and forecast that demand so will forward.

more million balance get on be basis. cash then milestone the breakeven once that revenue an being short sheet, think we'll past the just of I will $XX to bring we EBITDA

of stock careful I components on always probably just certain think to components, year be it's because we'll suppliers change. the easy to switch not beyond increase safety out

So that's answer What second, your question. the Yale? was to first

Yale Jen

see at When product, time? how that have you do launch you adequate? start the you preparation Or that to

Gerard Michel

we do adequate. So have

I stock. we'll probably, every orders think will least will -- worth we year, have coming up, the shows in of we melphalan based once and year's at this on have a component

Yale Jen

given of the patient Okay. Great. there's will guess, all ultimately of sites here That's the your estimate the that I XX next half size the total in the, helpful. is And indicated be you combined? or of year. queue question procedure for potential second What roughly is first my number XX

Gerard Michel

what year? you are asking will full volume be think the the I So for

Yale Jen

full the other the guess, For year, I from XX, [indiscernible]. hospitals

Gerard Michel

Yes.

year. XX sites month of and a of the stick before year, least me then a And sites -- the least up I do month. here, little what up quarter, you is at definitely have up the end we'll X range, least is X running, end can with at to of I doing Let quarter, -- with that bit is and and the running, and X the is XX and that trying said and and running. math, X I think and -- ensure a the at I is least year that probably the should -- think ending mean they'll of which end sites be the year, by at doing they Middle I'm exiting

to of get volume terms minus on fairly range, depending can assume the quarter. wide XX% a or in You they when plus within get you there

In patients have you by how whatever divide [indiscernible] number terms many X. that it represents, of

Yale Jen

Okay.

-- be our in [indiscernible]. number, you product any other is anticipate they become maybe last that launched there or in question presumably color Any when procedures and any that? people And the good. words, the patients patient the on to here is Sounds you

Gerard Michel

Yes.

commercial That varies So plan sites having supply transition with to conversations we sites. or are is we EAP patients -- over -- by we'd the had once It commercial like site. the with conversation available. to patients

of the that patients that, up and or automatic. That set be will an why there switch patient in not not will but whether the a if important course, treating are know wouldn't them. be it We stop there'll from coverage, it's chose don't quarter the be EAP. half force we With it. force the reasons that have way we can't percentage the so doesn't it But set could some of is over X/X protocol up some exception, I to patients who we or we treat first we'll meaningful not

Yale Jen

That's congrats Okay. -- on progress. And helpful. very again, the congrats

Operator

Next with question comes Swayampakula Wainwright. H.C. Ramakanth from

Swayampakula Ramakanth

from This RK is H.C. Wainwright.

so -- ready or the preparing the getting -- -- as and do some getting training KIT see these as taking it's that physician of long and training these to teams think drug -- do is like training. the of feel you January, can centers terms more teams you for in that surgeries? of some your of launch you hospitals, And terms of in surgery teams that, also, for In they you're launching doctor the you a going start evolve their that when how start in you how doing are time start in

Gerard Michel

Yes.

terms of in long, how really varies. it So

site have so or their -- and immediately We on them. a it X having or of month X, that month having a done discussion maybe discussion got a a jumped preceptorship with within

requires We have anesthesiologists multiple et been difficult where the other cetera. get herding or [indiscernible] all used one-on-ones which and sites calls flight, the that, it's case term in at [ and [indiscernible] to ] airplane very same an an time, cats again, on I've radiologists attending

-- sites. is right up the the the of that will of as reasons requirement well, that one those, have because saying, sites that's I the Moffitt about to Moffitt that's XX done then plus. on proctored, checks docs. that planning a within think as that months recent end European a they box think receptor, some getting have why I'm I that to X have we we'll And team well X So need number just sites X XX look, probably of in a certain now, reason have why But hopefully, past off we're -- we at look only experienced having

be We're preceptive expect experience We issues sites. to there'll some experienced with getting site an site.

that be second So item. will the gating

on Again, -- maybe XX we That's really ships, predict. we'll XX to tough saying -- And be can't out we don't have think we're decide going exactly that we to get will which it's X X which the of it prececeptor be. know board. it's where will

I -- multiple they sites sites beyond to and will proctor. think be XX more next the that's when get cases it's Once XX the do a think And more lot cases, really sites running. I more to be the as up a they of it beyond Thereafter, have cases get do can of get end all they we'll And proctor. have and sites a experienced accelerate. towards sudden, can simpler year, that it back before will

will So more will the of more next towards will take of beginning -- longer in be much end year proctors. beginning are end it as to this year towards of year, take and It it varied, predict. next available sites than the then hard to the the

RK, hopefully, that So question, which basically, is the answers it depends.

Swayampakula Ramakanth

KIMMTRAK. the [ got HEPZATO ] No, to I versus of KIT from move do with to conversations, how of And conversations And then will go to you any KIMMTRAK that. having. trying see things be the treating get terms -- to to of even you do sort have some and up these docs And think you treatment hospitals when you you in of on -- what KIT. get in able do end

Gerard Michel

example a Yes, you well, Kevin, from will what an rep perspective, I give the conversation commercial why -- think be? don't

Kevin Muir

Yes. field KIMMTRAK replace I now we right Ultimately, had sequence. in think we've go probably that if conversations have these best on each potential that going don't are in these have use therapies patients not -- revolved to around the other? The HEPZATO treatment, to the How been X can at of lines sequence? complement KIT. X least X. What's they will with

survival. going order is the best to So longest what is provide and patients overall with options the the that ultimately, these

So really the on so focusing HEPZATO either/or or that's KIMMTRAK. the much around, KIT have between not where conversations been

Gerard Michel

XX% call the to this for and overall indicated has it's remember this, KIMMTRAK XX% I remember, I think the important does on but think about everyone also to population. And of

this conversation is pertinent So subset worth the everybody highlighting. knows but a that, this patients is that to -- but I we think of --

Operator

would concludes question-and-answer closing remarks. to like turn any conference session. the This over Michel our for I to Gerard

Gerard Michel

commercial the taking updates afternoon. good uptake. everyone, and forward have to Okay. time look the launch I Thank for that you, Well, I thank to to this providing regarding future and subsequent want a evening. everyone

Operator

conference Thank The attending today's for you has presentation. concluded. now

now disconnect. may You

Delcath Systems (DCTH) 13 Nov 232023 Q3 Earnings call transcript