Earnings call transcript Q1 2023

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Operator

Good day and welcome to the Delcath Systems Reports First Quarter Fiscal 2023 Financial Results Call.

All participants will be in listen-only mode, and should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today’s presentation, there will be an opportunity to ask questions. Please note this event is being recorded.

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

David Hoffman

Vice once Interventional quarter and of are to Systems’ Officer, General Dias, John, Delcath Michel, Clinical Anthony Affairs Thank Kevin and John Development, call. again Purpura, With Finance. first Muir, Senior Johnny Dr. earnings Executive of call President of me XXXX Medical Chief and U.S. you, Manager Officer, welcome President Oncology, on Vice Gerard Operating the Chief

reading like begin statement. call Safe I’d by the to Harbor the

the to in facts, pursuant with Securities and XXXX Harbor the for Litigation made Act within described is of statement of XX(e) All may Section call, Safe forward-looking statements forward-looking of statements Securities XXXX. on the the Reform Act historical Act This considered the Exchange the of exception this Securities meaning of Private be XX(a) statements of of XXXX. made Section

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

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

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

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

Gerard Michel

today. joining for everyone you Thank

on the NDA has determined the would response, that working PDUFA routine information during on approaches. with expected entails XX complete that notice filing the as review. NDA March constituted receiving Since review a resubmissions been X process requests the the and August February an FDA company agency on date XX resubmission primarily a the XX be This Class

question be we have indication agency an time know will advisory received asked, will at meeting. committee schedule I the whether Since the about no this

until we assume will be will otherwise, we course, Of hear to one continue scheduled.

Given financing Hepzato, the of if the date, and our for PDUFA are the recent accelerating launch approaching approved. preparation commercial we

either patients is treating potential preparation Our of that of prior referring centers, in and a trained identification are is few months commercial or comprised oncologists sites, expanded treating commercial therefore core access after launch a the treating within part trained the and to that are protocol which approval. model sites becoming of committed to

in activities. have enrolled As currently mentioned more expanded sites access four before, we with has program undergoing the Delcath start-up sites three

sites sites have we five treating total sites becoming approximately are In launch. their other the addition, intention there with believe frame post sites Hepzato approved, potential short treating expressed to if kit the is time become relatively a in XX in in so over

will sites sites, continue additional build have number referrals bottlenecks identified treatment do believe oncologists as to While medical we treating launch. that ensure this will of seek post we we not from

the A to that our second were outreach Recall the to is Focus a majority investigators oncologists. launch oncologists. key medical U.S. component of surgical in successful trial

education set by the ocular month. affairs on to MSLs data, medical the we field started with to very thus need out focus of our melanoma oncologists have KOLs, supportive will metastatic and we we While a with launch, number have the next MSLs broader in Post familiar we will continue medical of team oncologists. a medical have build

the sites. on The the to to of supporting be working focused potential focused treatment centers, opening the team existing on centers for treatment facilitate management on oncologists on force to sales referral with sales patients recruiting treatment will medical team. begun and calling team one force bifurcated appropriate second new also have treatment We with

with because conducting that this that Turning independent I won’t note work, yet on The publish study the planned by have about include XX and interim those seen the patients, interim will the us Chemosat pending know Based study these of randomized to Chemosat investigators results we hepatic the again; extensively analysis metastatic ongoing they past medical have review the of of anticipation percutaneous on in conversations ocular on pre-planned are results melanoma with immune will end informed in the interest clinical I nivolumab. track small prevalence percutaneous plus comparing spoken to treatment and results with with analysis of a alone and Phase ipilimumab year. oncologists, that XX for there the CHOPIN perfusion signals we given however, the perfusion calls, patients. I hepatic therapy treating preliminary strong oncology is

public in focused As with to as financing gross Stonepine investors on a Capital as healthcare will by Capital, closed XX Serrado well company as proceeds, million investors, million equity and $XX previously that provide reported, up from funding. with led Capital, upfront well March institutional $XX existing as participation Advisors. including including private Logos [indiscernible] deal investment in was approximately Rosalind The investors Vivo Partners, BVF the

and these be commercial we launch ongoing million to backing to have profile from the adequate care-focused will the believe the support initial $XX We delighted funds, preparations. are high financial

previously quarterly $XX achieving $XX and financing gross another in upon in proceeds The proceeds approval then in mentioned million million million another will $XX revenue. trigger upon gross

financial we price these perception that launch from eliminate fund of $X.X the often XXXX, of enhance deferring we resume and XX, approximately transactions financing Together, hinders XXXX agreement XX, In to two to reached preparations September appropriately period our to should any which Capital million loan on payments. had addition, appreciation greatly approvals. ability interest-only March product principal announced overhang upon with an a Avenue Avenue share the

to Tony the review to financials. over to I Tony? look call but in we’ll moment, questions first taking forward a the turn

Anthony Dias

Thank you Gerard.

announced our release, procedures, review Delcath’s close and of valuation private earnings preferred including that the previously our year-end work and customary in of placement the certain XXXX, issuance with stated XX, on no the As closed stock we’re associated financial quarterly completing than process filed quarter in the in first in the quarter XXXX. XX, end March report reflected which Delcath’s full Form on warrants results will XX, XXXX. and of be are May XXXX later March XX-Q, as

the The Revenue the transition months $XXX,XXX is in due which XX, expected three XXXX, in volume. $XXX,XXX increase to ended revenue unit compared in was XXXX as estimated XX% March increase in as to three to for occurred Europe the March March to be approximately the ended XXXX. sales for product direct XX, approximately months well

to three months research expected development months compared XXXX, to March three XX, XX, for March periods expense the as relatively the For flat ended both million is and to compared XXXX. ended be $X.X

cash million As towards cash $X.X March in principal the compared restricted equivalents was company placement and $X.X which cash by $XX.X as million on XXXX from existing due operating million as and XX, $XX.X of XX, $XX.X had million Avenue. in of cash private totaling offset to of of cash, payments XX, of increase closed December loan the XXXX. with March company’s cash activities the cash, proceeds XXXX, million the to use of equivalents cash and totaling restricted The

Operator please check financial remarks. phone for That you the the open Can I’ll concludes questions? lines ask Q&A. my to for

Operator

Thank you.

session. answer begin question We [Operator and the instructions] now will

Our Laidlaw Company. go first from Jen & from Yale Please question ahead. comes

Yale Jen

plans and any is the morning got all have for pipeline and in thoughts more thanks One already questions, any questions. Good taking I’ve on the given you or two congrats cash, guys the progress. and here. I have development, then that have--will follow-up

Gerard Michel

our activities committee being. restrict we’re to for meetings advisory pipeline Yale, going to the probably time Yes

I but in I actual going With said, there clinical don’t think to patients until prepare, next is successful a our that year. see focus any primary be on dosing probably will activity sometime parallel launch. significant

trials they trials Now investigator-initiated this with indications, in prepared with by whether put front and tumor a oncologists, agents we support will indications it’s immuno-oncology have later other in of other without we But that us probably both number hopeful indications. likely or of be agents. additional immuno-oncology as those we’re with we’ll are trials starting doubt interested to running next combination year, combined and year other other types in are that said, a trials

Yale Jen

Okay, more here. question helpful. very very, one That’s Then maybe great.

there as Any competition in well competitors the recently in studies comments think thoughts, of broad the as may of One happen? that the possible on reported are lines. any or type ocular I not would--thanks. color line Any melanoma first in what happen

Gerard Michel

good data, I in which referring I quite of looked duration Their of thought more with think our like response Yes, product. ORR seeing myself. what we’re looks the and IDEAS realm to [ph] you’re

through go things. line I patients, one think to is patients what’s two of One, important more than therapy. note most

local well are, I course, with treat this that systemic is second latter, should therapy. direct regional most both of coming The a as being so see believe The us. oncologists therapies a a we what therapy competitor get medical systemic out thing as disease additional patients as don’t is

liver think question what’s I most to disease, failure most really the more these patient. for due I us a usually they therapy, to best that data think needs generated of I I goes the and is a local systemic the first, what or would determine regional be for for mets, be know succumb to there at will patients, of do these from is some it liver patients. point when to place so note

Yale Jen

Congrats on the and helpful, very That’s great. that. progress. Okay, appreciate

Gerard Michel

Yale. you Thank

Operator

HC Wainwright. ahead. Our Please next Swayampakula question from go comes Ramakanth from

Swayampakula Ramakanth

Good me is HC Good quick morning. morning too. This from RK Wainwright. Gerard. of A from questions couple

treated run, under EAP commentary of both treated the of have experience been so how and from us far are program the an physicians so many program, and being the could patients? terms far or also patients that’s any idea being give on this In you

Gerard Michel

to year, don’t the right Yes, XX - well a at patients XX XX think I probably have so then out they from had estimate of this so they’re point I pace, I start XX the had need the as this range the on it’s precise past the at number. now guess an to in of If somewhere be patients of treated. that probably based me,

on should will the hopeful the data, is response seven seen and with patients ORR sharing is that is course those that report I continue we’re they’re but end point--well, to as primary - patients, results All randomized is not is not wait. we’ll that interim the It on, of early number the as say data, us. trial. have of rate very we small the time hold, in us what to share objective a goes signal can of they main was appropriate with

control, the patients, to important that so issue treatments didn’t XX% and I any that data to and X.X to and were handle later disease that XXX% duration the can interim physicians about If PFS turn fingers the of rates, toxicities at we before, roughly I think of when get there would talking patients, response larger response held be of was undue sequential that think start don’t very response as I they so the with. response crossed a high that very or this think year. seven data tolerated quite could was be arm with rate, they the years well. Again, very, last duration the level we cut,

Swayampakula Ramakanth

it’s into At becomes approved. confidence getting to don’t Then Hepzato. you what centers using Perfect. getting encouraging know adopters if centers to think adopt which you up their ready more for do dividing of lining tiers, of have Hepzato regularly and early terms you’re the the of and do you’re as therapies this work gain that market to number like in market point, on can others is that be--I start kind and who liver-directed when different

Gerard Michel

the and you it’s a - if therapies. number think least I centers know two in at hundreds terms TACE primary that Y-XX, liver-directed don’t therapy, of In which number the are precise of about do the liver-directed

have be of nor to get this percentage into to indication, For it we any no prudent particular try meaningful would need, that.

much had if say going would people reason centers, but treating to flex and these conservative, on XXX keep or months, running XX centers say patients. is within to might can’t be for see we’re us three every about--well, this we’re see up, tabs three TAM peak. with is hard to XX that close at XX it’s and past--and launch, only or I of but let’s maybe recall fantastic. that we months, past up some The we can’t want I going saying down number is that say, it us think six again our centers, I

of one to so one to see want like to phenomenal months. XX XX, is support speed, the with accomplish think center to don’t support at if happy that. we three very centers I have up I’m pipeline a referrals those up if that, doing doing I’d we a again two peak. I well to least launch of make a they’re trained, these quarters two most the month at the have will every launch sure can That post team the to centers. just mean to

Swayampakula Ramakanth

very questions. Thank good. taking much Very you for my

Operator

if you question, press a have Again, then one. please star

Bill from question Maughan Genuity. go Canaccord comes from next Our ahead. Please

Bill Maughan

Of you how they thanks. or and of question, have so dozen either that do currently morning the Good the at second are you any patients or online of or as that? even payment have you where interest, for on-board timeline many point are sense preliminary Thanks. have represent? Do expressed sense on sites they’ll Then Hepzato a payors? have it with of can initial yet how any discussion launches, you sort

Gerard Michel

the going of reimbursements moment. you through in question I’m Sure, that with let hospitals a to how represent. me many ask handle the they talk of Kevin, dynamics to and in part first terms

the of they maybe equation. from because focused really--you XX, when of hip, But patients of part centers patients. that’s a know, represent, of XX% the shooting maybe on already of number that terms have set we’re only In we those [indiscernible] XX%, the that

these the of equation. equation open to other part to to intending out where medical oncologists treating the part other the of in to and sites, going not we’re That’s get sites. The is refer

about is sites assume to than Now, sites one, equation both that, might is of kind worth we four a do enough is of that than if the average, eight XX, treating probably before, for referred have sites, which month. a the to more want is then of the varies. site getting be again that week able key if able have don’t think reason--you the XX sites, two sure what to about that do a that we the four make said not if we’d so one assume a average per know, we month, I treating generate some But two to But patients site, doing Ideally revenue. those we to we month will every as million sites be several might it others months. one a - be do a to month more parts hundred

Operator

like concludes to This conference-- answer and our question would the session. turn I

Gerard Michel

No, hang on.

Operator

I’m sorry.

Gerard Michel

Kevin, dynamic? the you reimbursement for can the in [indiscernible] chime hospitals on

Kevin Muir

Yes, I can.

think significant is found we’ve and have far research the past Over period some market our payors, of through strategy with prudent. market we that time, done so research, the that we

in place and We are the we have we team to get. a handle market that prepared access questions

them are The payors--or to true outreach standpoint, when our to and we’ll the itself payors We’ve the will but happen from have those shortly a prove we will upon from to we’re EAP some like the from strategy. we take see approval to sound that--we when out. the how payors, strategy talked think confident that converting mean of I will--and taking clinical market market access--I so we commercial a mean patients we patients a said, research clinical from payments, patients I commercial,

Gerard Michel

be what’s correct? think important, majority Kevin, is will of the patients the outpatients, I Yes,

Kevin Muir

Yes.

Gerard Michel

reimbursement C-code, a initially? under will be So correct, the

Kevin Muir

with and start the after. a hopefully traditional to we’ll a shortly of J-code C-code Initially go path

Gerard Michel

expense. it Right, a for be the will so majority patients, of pass-through

Kevin Muir

Yes.

Gerard Michel

through is Given that outpatient these be patients with, to of night, again that the basis, not be and this an hub on that. an to small bulk it end service so will given product, fact able bundled that told minority patients centers of an of they’re they’ll the single is the these academic stay be up need a issue a patients number treated will past an orphan pass-through. has to that are be on payments, what extra But working of for probably--it’s going an they sophisticated us ultra night inpatient here very being our maneuver basis, the may

Bill Maughan

Got very much. thank you it,

Gerard Michel

Okay.

Operator

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

Gerard Michel

Yes, I thank the taking just to want listen this in. to morning for everyone time

we the as down going but of keep for Thank ahead work day. heads great a of lot support. forward. a have Have you and our push for We our launch, us to prep we’re again

Operator

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

disconnect. now may You

Delcath Systems (DCTH) 12 May 232023 Q1 Earnings call transcript