IOVA - Earnings call transcript Q2 2024 | Iovance Biotherapeutics, Inc.

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Operator

Welcome to the Iovance Biotherapeutics conference call to discuss second quarter 2024 results and recent corporate updates. My name is Daniel, and I will be your operator for today's call. [Operator Instructions] Please note that this conference is being recorded. I will now turn the call over to Sara Pellegrino, Senior Vice President, Investor Relations and Corporate Communications at Iovance. Sara, you may begin.

Sara Pellegrino

operator. you, Thank welcome discuss and results conference and call corporate Good Second to Quarter to our XXXX and webcast update. Dr. afternoon, Iovance's First and Half an Chief Fred U.S. our Officer, President our summarize and Vogt, will updates Interim provide introduction for and key Executive including commercial launch pipeline guidance revenue Amtagvi, our and program. additional Commercial, U.S. of Ziegler, EVP details Jim will highlight the launch Amtagvi in of advanced commercial melanoma. Dr. Igor and capacity experience our commercial Bilinsky, manufacturing Chief Operating Officer, will plan. comment on expansion outlook; review our financial including and Jean-Marc Dr. financial Bellemin, will CFO, revenue results, and will Officer, Medical Friedrich key clinical Chief Finckenstein, update. review pipeline Dr. Brian Medical and Dr. Gastman, Affairs; EVP Puri, also at Raj website session. Earlier on call and be a EVP, we press could corporate afternoon, our iovance.com. Q&A the the found Regulatory Affairs, on that release are available this issued for

this plans business will Iovance's activity, conference statements regarding Before guidance, business and potential focus, forward-looking feedback call everyone our research start, we and like during approvals strategies, and to include future goals, I'd and regulatory and trials expense and commercial remind guidance, revenue guidance payer activities, and transactions, manufacturing and plans technologies, clinical collaboration interactions, revenue made licenses and preclinical that cash statements results, and of position interactions, capabilities, applications updates. future regulatory

which risks time and subject are are many our the time Forward-looking statements beyond SEC including and in uncertainties uncertainties, control, to to numerous our from of risks described filings.

will undertake Our results I may call Fred. to the obligation no We update during from publicly forward-looking those call. differ that, turn materially over today's any statements. With projected to

Frederick Vogt

year patients at following commercial host approval XXXX Second melanoma. Quarter successful of results. the Thank FDA a We've Half advanced this and conference our so Amtagvi Iovance launch start I'm discuss and you, afternoon's far Sara. for U.S. first a pleased with productive call our to First to had

First, we the with pleased demand exceptional are Amtagvi. for very

is our months to delivery, was is awareness, indicator providing inclusive demonstrates Amtagvi well and a million, broad initial success of high few a ATCs. strong our or while upon revenue. The Proleukin. from from launch Amtagvi for and U.S. centers future revenue as revenue product recognized of prior Amtagvi early typically quarter treatment demand execution revenue unmet recognized second of Amtagvi upon revenue patient access leading recognized as the product authorized motivated revenue infusion, Our $XX.X need, Proleukin quarter infusion, of team's

With for already expect the we treated which the continued I'll setting, Amtagvi meaningful return launch momentum, showing a in a benefit patients to commercial moment. in

very to training, than As Jim proving These ATCs treat will capabilities have have current they more with infrastructure XX a and Amtagvi. patients the engaged discuss, ATCs. of we are network that

strong track initial of We started our to network XX ATCs also the remain on community by have ATC largest representing year, ever therapy cell launch. We've end a at for least also referral the reimbursement the a activities faster logistics patients. additional success ATCs. scheduling these and demand between treatment to drive ATCs, with the Through and Iovance early also time for becoming to and collaboration for is

demand. our staffed that successfully The capabilities manufacturing Ziegler slots expected current meet to addition, pace. Amtagvi increasing to but provide an at In summarize, will manufacturing takeaways, delivering we commercial and key are are

scaling according up manufacturing our growth are We to projections.

and month We capacity launch each have and continue growth. to headcount increased demand ongoing up match since ramping

afternoon's to back release. momentum. press launch Turning This

infused the guidance growth third XXXX. XXXX for demand in upon for introduced and the and guidance is in experience Amtagvi been uptake and including the April more than quarter-over-quarter quarter strong confidence infusion patients to the XX in million of the also in full XX ongoing patients We Amtagvi been the XXXX, of product infused revenue with This our scheduled distributors within revenue prepare launch commercial dynamics $XX guidance. in already total the year support based visibility More range since foreseeable infused since adoption used third to and Notably, have anticipated end infusions future. third $XX or the more the for first infusions, our network, restocking the expect manufacturing second XX are quarter rate start capacity guidance. In patients to and Proleukin our We sales quarter. quarter, before Proleukin of additional of our corresponding quarter. are this we have of ATC million. and Many across growth the significant than

For full to Proleukin anticipate for total Amtagvi $XXX we year and XXXX, million of million. revenue product $XXX

will the sales Amtagvi XXXX corresponding demand and Proleukin. full continued for expect year for growth We reflect

U.S. year and XXXX, by we robust calendar driven For over calendar launch, additional and full new contributing launch in referral networks demand. first year ATCs year-over-year community growth U.S. to our year first the expect scale-up of significant full existing

previously revenue As melanoma Amtagvi more U.S. highlights a line Amtagvi represent as more XXXX. In billion beyond, to we'll and to treated revenue continue for total address the cell and are margins strong the in million additional long-term to also footprint. call. Gross This represents Proleukin front Future treated later These wider other revenue for our previously lung in expected Proleukin annually as growth. melanoma commercial million indication expected alone. to discuss also full the next the significant several the a Globally, in years. $XXX future we advanced XX,XXX the Amtagvi reflects a to initial drive than than growth anticipate the and of strength a melanoma, $XXX advanced over to in to U.S. non-small U.S. patients multibillion-dollar and expansions products currently XX% geographic increase $X are planned cancer approved in XXXX label across product result, in indications for opportunity greater and than geographic will footprint to increase peak well opportunity advanced market the include global Amtagvi drivers year as Iovance. and

on globally. and growing is in our existing and launches and to for recent in to European we follow. XXXX, submissions the track Switzerland the commercial year positioned regulatory submission Iovance our Union, remain success with Following this U.K. build Australia and well additional in commercial Canada continue upon

may even pipeline help curative pain exciting and more patients robust medicines. tumors solid our Amtagvi, to addition with In potentially

we trials cell and next-generation indications, this registrational pipeline Our are other in programs on with innovating detail Friedrich continuously include further therapies. discuss our will call. X and

intellectual with pipeline competitive cell provide together therapy, property manufacturing approval advantages. distinct our deep with TIL first launch with us and in The position large-scale

fully a therapies positioned delivering maintain for to in company, As developing hand is Executive over with leader integrated global Jim? U.S. and of Commercial, patients will Jim, our now cancer. I'll summarize activities. TIL commercial Vice the innovating, cell President well Iovance to our who

James Ziegler

you, Thank Fred.

lives for with U.S. about excited of patients Amtagvi improve of are melanoma. potential to advanced the We our the launch

are positive in are streamlining priorities the launch our As patients including their months and with progress, increasing from An and posting and more expediting commercial are have more benefited today early and Amtagvi about number patients patient ATCs our objectives Amtagvi, sharing feedback journey. stories to highlight community treated of access approval. My and expanding adoption network, U.S. our reimbursement the patient and since ATC referrals, and within utilization who

driver network and centers we continue. Today, a which U.S. planned, are more ATCs. than at demand complete key of is scaling many robust ATC as expect and who scaling demand were to active The multiple patients. XX is treated approval expanding our First, and onboarding is at have up

preparing major onboarding, have are Newer U.S. or beginning completed centers recently treat to cancer including patients. ATCs that

approximately have year-end. bring to is to As patients, ATCs to treatment we XX total in closer goal our look by

nearly awareness are XXX An in ATCs among expressed proactively community testament the and closest awareness X-hour will located center's community with our additional referrals outreach Community building in growth networks. Iovance of miles about centers XX network. Currently, out need an of ATCs, ATCs. melanoma to unmet XX% melanoma, a number, across a and be treated by offer all further Amtagvi community are increasing referrals ATC, patients to deploying than direct these each more and joining rolling scope Amtagvi also patient networks the volume resources are center. number dedication The of the is of into to advanced within and demand interest referral and their have to ATCs and oncologists. drive this support patients community. many within Beyond referral are our initiatives interest driving the in within significant size

and ATC access critical to addition adoption patient In for demand, uptake. is

Amtagvi Amtagvi. covered Our private are are patients XX% coverage access reimbursement that payers and by as launch indicates policies facilitating broad Favorable expected. to data of medical approximately

reinforced Amtagvi's support and NCCN the First, Network data in Cancer guidelines inclusion payer National coverage. or broad Comprehensive clinical

achieved accomplishments months positive since with coverage payer only significant X in We approval. have also

up which financial at in including is clearance are efficiencies also to weeks, the parallel X of from more a today, million medical time lives launch. approximately X average have implemented treatment. already weeks X and policies significant scheduling The clearance payers more ATCs, speeding at the is lives time covered than U.S. for XXX are responsible to positive of As consistent NCCN reimbursement or also that clinical than to Improved faster reduction is coverage trials XX% to treatment. driving financial guidelines. Successful initial with label, current with time

pleased to timely towards revenue performance. for shorter to who Operating the broad and very We as dynamics payer is the gain These summary, becoming continue more the are demand in treatment the ATCs expect time extremely strong faster. place are early experience. In coverage There and with ATCs, is at our trends and favorable policies to launch to like to Bilinsky works access team talented Chief treatment Amtagvi to would Officer, now strong growth progress. tirelessly time cross-functional guidance we our and projections in highlight pass Amtagvi. I call our I also ensure to manufacturing Igor product our Proleukin. to will our acknowledge support

Igor Bilinsky

clinical and as capabilities, Today, of efforts. Manufacturing Thank progress a like launch manufacturing competency commercial core as of highlight commercial is the ongoing our well you, I'd our our capacity expansion Jim. to Iovance.

the laser product through focused We on of of tumor incoming shipments and manufacturing product. receipt quality from final samples release outbound to are

and committed therapy Amtagvi the or one largest patients since manufacturing in the This supplying a trials. facility, is manufacturing. The by approved been Located our core integrated Center, has Amtagvi for network. patients manufacturing FDA Cell internal cell facilities cell is of to and while established deep TIL of designed continuing in only for serve world's has iCTC iCTC manufacturing one the facility our Our to therapy and manufacturing the Iovance specifically Therapy team approval Philadelphia, the iCTC, with fully is clinical experience. global commercial

in commercial at experience the our ramp continued iCTC manufacturing colleges demand with match closely pipeline. also network, supply access well Philadelphia clinical are partnerships as We groups. Within an the our demand. actively to of contract workforce provides provides as iCTC cell and Amtagvi gene hiring FDA commercial additional by a The local support and for and in U.S. innovative therapy site with the location experienced to trade flexibility manufacturer to and is and to capacity approved manufacturing and

Turning commercial updates. manufacturing to

date with to experience. our experience with and Our clinical prior has expectations been consistent

up with month-over-month February, commercial demand. growing to scaling we closely as and the have planned. FDA manufacturing it Since continuously staff been increasing executing the are our approval We capacity in align

available have the meet and in capacity increasing to We Amtagvi sufficient network manufacturing demand. staffing our

capacity high utilization ensuring at We slot network for running while are now ATCs. availability our manufacturing our

In to return manufacturing of receipt of turnaround on for target with at time Amtagvi launch facility addition, our of has the shipment days the patient to product from been the XX our plans ATC. approximately cells

As unique competitive advantage cell we time over and we're focused scale therapy. improving leveraging operational up, TIL by efficiencies our leader as on cost economies and in scale of of the also goods through and the position

Turning the with has today to provide growth our closely our for built therapies demand aligned are projections. facility efforts. per than year. TIL expansion capacity X,XXX They patients to more iCTC is

X,XXX submission iCTC and TIL Following supply our patients the patients can for geographies. campus. years. Longer facility therapies commercial to building those for cell iCTC upon we this process beyond the filings, of Amtagvi out so Europe in in annually supply the therapies than TIL in is few EU more shelf term, annually the in and provide XX,XXX over regulatory iCTC, from vision approvals at next space additional to ex-U.S. recent potential We're the planned patients existing expect

option efficiencies manufacturing another have and We drive adjacent an by to incorporating automation the to process. in on additional lot increased building construct plan our

Iovance our expected robust at therapies portfolio. in answer the our Amtagvi additional committed Ivan's our the through excited available will XXXX. In TIL manufacturing allowed owns firmly granted Officer. hand to to XXX than and or more Q&A, and currently questions summary, exclusivity other by call and Chief over cell rights U.S. technologies are and and Amtagvi a for patent that Jean-Marc, investigational provide the now I'm capabilities Importantly, Financial patients protected patents team manufacturing during with intellectual are for and cancer. I least to international to TIL-related delivering property is

Jean-Marc Bellemin

first will revenue will review I the Today, well XX, position cash quarter our also as our Igor. including guidance. and results I you, on as highlight our June and for Thank ended expense current financial second half outlook, XXXX.

a million in $X.XX the or which to for anticipated during per XXXX first loss million, and million loss or approximately July XXXX. XX, cash sufficient net quarter compared the XXXX. June cash be $XXX.X was June period investments the was December million expected financial to per from end the planned quarter The as XXXX. I product of to revenue infusion. approximately initial the or fund well transition Iovance for XXXX XXXX. cash, had $X.XX of per are was Amtagvi XX, months $XXX.X at our of from ended raised an quarter Net or financing of into cash share $XX.X loss Proleukin. cash of net for revenue million proceeds equivalents, As current facility loss compared $X.XX operation $XXX for second second as revenue Iovance XXXX, a product of $XXX.X share recognized and $XX.X of XX, quarter of million from X position half the We an year-to-date will revenue million unaudited results. quarter $XXX.X current of the to Amtagvi $XXX.X and million million of to for quarter includes equity of the per share position and recurring third XX, completed second sales had from XXXX. Revenue share consisted net and of XXXX at-the-market second of now $X.XX restricted $XX.X and ended second Net

the product million first global both and during of quarter the XXXX. Revenue June revenue Amtagvi of the XXXX the growth and to in second supplying XXXX from we $XX.X of was Proleukin initial in Revenue our significant half began $XX.X as in to periods half revenue U.S. recognized of of from as revenue for for year also XXXX We ended Proleukin XX, and period attributable Amtagvi treatment for for million the global distributors. Revenue quarter X Proleukin, Proleukin recognize regimen. for launch which during in $X.X primarily consisted were prior was Amtagvi. million the months specialty the first over U.S. increases U.S. well first use half in sales

demand in As Amtagvi. for is use leading of ATCs Revenue recognition when and with advance specialty near-term Proleukin Fred XXXX, than second quarter a few Proleukin strong months for strong Proleukin Amtagvi annual Amtagvi mentioned, infusions. Proleukin a Amtagvi reflecting Proleukin for earlier revenue indicator surpassed global for distributors growth. is purchased Notably, in revenue

payable signal and million, X the have of manufacturing our in XXXX, for purchased attributable million, primarily first with for already already the In costs first launch costs and during XXXX, months of to costs assets. success increase amortization in we was is half X the Proleukin related the and addition, increasing sales utilization, the sales. Cost volume expense capacity quarter was cost of were ended available specialty distributors Amtagvi who XXXX in prior half $X.X The is drop of and intangible commercial the and sales the periods off XXXX. X a the started U.S. and Cost Amtagvi as of related capacity. $XX.X to million associated with function of related over XX, up is year strong sales of Proleukin second non-cash amortization for Proleukin, restocking second which positive launch initiation and of another scale associated XX, of ended improving intangible both sales June primarily and for and to X and quarter June for of and months of $XX.X demand non-cash used Amtagvi. Cost for Amtagvi manufacturing with assets product patient rates, certain royalties on respectively, primarily sales the

X-month were the XXXX. The compared the of expenses development samples prior the selection as and million over of well focus half of $XX.X million tumor million XX, X the XX, a of as support to first Proleukin. compared $XXX.X and continued attributable million general and first increase administrative in in XX, and education Amtagvi costs, margin for of and as In selling, gross to pre-commercial general second ended XXXX same an in qualification compared decreased of as and ended and Selling, ended June resections, periods the overall to for expected to of in of the offset increase an several the quarter next growth second period were $XX.X efficiencies June June $XX.X sales were and in to training increase were 'XX and partially our of million $XXX.X $XX in activities XX% and completion growth of to of operational the period and stock-based stock-based commercialization -- costs primarily increase $XX.X the costs and the and primarily June the year development half on administrative compensation, our to infrastructure in attributable million related the general compared of expenses were the Amtagvi the research ended to to $XX.X clinical first cost with decreases by half same more the cost expenses second for first of period the the optimize June reach the $XX business the years. Research expenses year June to compensation XXXX. were aim associated decrease same development optimize quarter corporate transition resulting XXXX. activities $XX.X XXXX. The and XXXX, we well are $XX This expenses than commercial decrease decrease prior in same over in for and manufacturing, compared for headcount increase the the quarter million to half million XX, of from research development million period and over related to Research ended including for $XX.X months million million in XXXX, as period legal of to certain and was XXXX. support expenses period headcount. Selling, the for a in XXXX, incurred 'XX million second quarter patient for target addition, time XXXX administrative

Next, and Amtagvi outlook our future like the expenses. financial cover launch I to for would

product curve reminder. and growth $XX to highlighted third add the to the In the quarter also year-over-year highlight we around expect for within guidance, introduction will In his new $XXX the of product for million for total $XXX trajectory to well the as continue annual to approvals, we quarter-over-quarter XXXX, Amtagvi. of as the million. XXXX significant beyond. I range years revenue U.S. Fred within Geographic to $XXX our million. and total $XXX million. full again year in As product the year earlier range and growth several with next guidance expect as we in annual XXXX, expect We of revenue million adoption product anticipate of numbers million revenue XXXX to $XX product in label revenue increase a in expansion a revenue steepening our full we

to mentioned, expected Fred to margins next greater as addition, gross increase In several over years. are than XX% the

reiterate $XXX to the cash one-time Regarding in burn range XXXX million of our $XXX million, expense to outlook, excluding year we full continue guidance expenses.

the continue also opportunities will spending. leverage to to optimize We

Chief be information, later our Form selected to our this and now will company's please Friedrich, release clinical discuss to pipeline. hand see afternoon's today. I Officer, Medical to of press the the combined in filed balance consolidated sheet and XX-Q For statement our operations additional call

Friedrich Graf Finckenstein

Thank you so much.

frequent only all which of have colleagues therapy tip in my conveyed our acknowledge to rewarding as setting. solid benefiting As about setting. additional the clinical pipeline potential teams to clinical clinical cancers patients cell news tumor settings and types. Today, patients we represents deliver TIL to for key including The with This commercial X from in address and feedback additional press motivates than teams iceberg the of for U.S. I TIL release. of more XX% with diagnosed excitement my the this thousands cell and hear I'll ATC own of like the afternoon's development potential tumors in the great Iovance Amtagvi our develop frontline patients. key ongoing would Amtagvi focus therapeutic is personal the in advanced the is that also priority registrational to for with highlights, cancer additional lifileucel melanoma from the I on will trials begin experience therapy

each across full in currently Our Australia, review with remains support ethics global TILVANCE-XXX commit the feasibility selected across XX approval active includes and careful including enrolled pembrolizumab at in enthusiasm as its advanced track time high to U.S., which regular XX sites with More and countries melanoma. Enrollment are fit local in III the arm the of board trial Site TILVANCE selection with of melanoma sites Europe site pembrolizumab for additional XX sites approvals than care XX registrational across does Amtagvi monotherapy on post as of patient population. site with including strong institutional geographies Amtagvi design, Iovance Phase countries, approvals the for the and combination trial for control assessment participate. Canada, globally. also activation frontline participation. anti-PD-X to of scientific well accelerated and is standards

also believe to option to is to arm TIL the cross over from control attractive patients. therapy the We

in potential in supported non-small Enrollment naive relatlimab melanoma II in oral inhibitor over accelerate of new also to frontline continues physicians investigate a XA novel rate response patients our immune XD lifileucel TIL IOV-LUN-XXX cancer. demand with updated and for As melanoma. XX% proof-of-concept to registrational nivolumab advanced data strong with our by safety to advanced with in lung our single-arm a alternative XX% importantly, Cohort and cancer. who profile. The in differentiated complete demonstrated another more in patients cell the frontline beginning combination best-in-class patients. Shifting trial is in Cohort lung represents Cohort pre-immune minute, responses cell a from anti-PD-X presentation after in durability reminder, rate post checkpoint an were checkpoint Phase non-small trial and trial era is including IOV-COM-XXX previously tumors. In a in This the depth published and combination data monotherapy lifileucel and to data and TILVANCE-XXX unprecedented inhibitors in IOV-COM-XXX than comes XA solid on of

in complete expect IOV-LUN-XXX for XXXX. in XXXX and to application the to supplemental submit potential cohort the and a enrollment We registrational biologics report license data topline FDA

the proposed well trial potency small the trial preliminary as data. We the support are post lung IOV-LUN-XXX on feedback FDA of based positive confident anti-PD-X as matrix provided positive the cancer. regulatory design cell single-arm our in accelerated on approval lifileucel on Also, to

We post regardless of unmet and endometrial have also approved Phase lifileucel initiated of for to patients the MMR IOV-END-XXX currently need vast multicenter trial cancer II endometrial majority repair treatment the or mismatch investigate post-anti-PD-X options cancer an status. the patients There medical is with no in in anti-PD-X enroll become setting expect to with we we checkpoint the to as with Combined IOV-END-XXX move from the This more will inhibitors quickly, treatment forward and setting. presenting enthusiasm into chemotherapy. frontline initial look data soon. immune gynecological unmet relevant combination need oncologists,

TIL approaches leader Iovance TIL optimize regimens. and forefront at the next-generation in As TIL the of is to treatment cell therapy,

in analog has treated PD-X for inactivated the studies trial or We next-generation are term. the clinical IOV-XXXX Interleukin-X with additional lung IL-X previously by of safety tethering TIL approaching augmented preclinical IND-enabling T IOV-XXXX effects the expansion therapy cell a to activity IL-X Preclinical cell melanoma cell cancer and TIL are or in the support therapy, improved and is antitumor the programs is safety driven the may data treatment next-generation use near via are in TIL TIL regimen. robust next-generation the IOV-XXXX or IL-XX. patients. Two cell engineered advanced a IOV-XXXX investigating in genetically for TIL. clinical improve trials in non-small with studies with inducible Interleukin-XX IOV-XXXX. or potential

to NCI, on National reactive or enhanced or products. we Agreement, press Research and Development preclinical development As Cooperative our noted in afternoon's this Institute of U.S. with renewed collaborate tumor the and CRADA, Cancer release, clinical TIL

turn happy are corporate these to Additional I'm press scientific our the well release and the now details over on as operator Q&A question-and-answer today's the deck slide call to about to address in presentations during programs as about our trials session. I'll and included additional questions the development the programs session. begin website.

Operator

[Operator Instructions] Jefferies. from Michael first with Our Yee question comes

Michael Yee

the Congrats on amount of you ask accurate. And make it just guidance. talk revenues a leading launch amount, huge buying of it's it certain of amount number imply not but good back questions of distributors Does good queue maybe into try include guidance. patients just time? the to a as know a built or We $XX the Proleukin to a into I can on guidance X I execution wanted then up? demand. Or certain to it a want is does just million that? We the square and that as indicator, that a Proleukin and to of

just And you differently, to so I patient the about I enrollment and if ask may to perhaps related on about Proleukin numbers want have that, to think your on numbers forms just any do think the queue?

Frederick Vogt

Yes, guidance Proleukin. include does Mike, the

Amtagvi we revenues. Proleukin as revenues include that numbers put guidance the all well as out So

on that the think the leading sort for we for this what quarter, be will couple Amtagvi indicator represents revenue next of quarters. over number the Proleukin Now of demand

a so is and Proleukin Amtagvi. that upswing you of We've can estimate the fit. now, it we're and demand given you than you our whole It's infusions It's internal large of to can You infusions. that guidance the way -- it's on XX number giving very use -- like where especially of the here. kind to what infusions through a understanding can see was is any model and uptake number see more going can of you recently, point positive and going. But look rely you of Proleukin both

Michael Yee

Yes.

an distributors, of a buying -- certain like a a or a just one-for-one from It's indicator. not it's clarify, certain amount to So up time. but it's amount of

Frederick Vogt

already lot because indicator, already they've that started They've an and reloading can't more. of It's restocking. sold already. that started I just product stress a they've

Operator

comes Lawson question Peter next from Barclays. with Our

Peter Lawson

well. Same Fred, this the The the used for therapy? for that of was as year versus for of revenues on Thanks for proportion was TIL? And congrats question then the that QX IL-X what's IL-X the and guidance, TIL progress. what breakout guidance, the IL-X full quarter, the

Frederick Vogt

provide to individual going -- have don't We aggregate on going the not guidance just the to Yes. provide products. we're guidance. We're

Amtagvi that You the of can exactly by because patient years, the use for vast can for you amount gets Proleukin Amtagvi. industry our Proleukin for We to time the your hear much in used comments probably going regimen. from it Proleukin in used second experience the how be majority Amtagvi of of understanding it it's to But getting question I'm know don't at model the of answer earlier from many Jean-Marc's you here. the got and

by perspective, massive that no way have it's obviously, upswing accounting the but of We being, tracking of Amtagvi. is an sales driven from Proleukin

Operator

from with comes Goldman Andrea question Tan next Sachs. Our

Andrea Tan

Fred, year where around in are confidence you the as providing launch as quarters? metrics plan enrollment I'm X-months just such given the have on curious curious guidance, 'XX your here, and patient past your you you then or just you screening in demand, And driving where what is stand full for now? if and given

Frederick Vogt

provide won't relevant may event. now we -- not we're you All guidance not Andrea, that revenue-generating us about anymore. hear the some is additional It's really talking enrollments -- anymore. on infusions, which matters is

We next talk guidance as over we're seeing fiscal is figure of we're of do the manufacturing X think, whatever you they're to all giving trying around capacity cases. going to worry see model Street all would know that quarters here. enrollments we're some go that to We ATCs 'XX give to for difficult, that can guidance, launch. our a the board. on have be on think dynamics. what we us out the how year I many and very we numbers, big are infusions. What's So you But know and X, We about in We the coming what stuff may know doing. that really, what 'XX see don't the that terms the we thing in the about bit how guidance? do. full confidence know We sort you can year with exactly details the We

So we're it you. going to provide for

part So initial right guidance now. such got on very we're we've the good seeing. what clarity picture we're what that on the because in seeing And in of very, of based far you dynamics so launch a we're have launch confident

Operator

question Wells Our from comes Zhu next Yanan Securities. Fargo with

Yanan Zhu

Great. the Congrats here. on progress

on couple questions a have patient I guess I of numbers. So

-- is for infusion of since quarter, infused patients. XX of -- the patient the You -- number the gave start which this infusions

can increase -- that patient the you X quarter, about current months, the Given also patient that the wanted to understand, that can just increase, within have has and rate, who will there? And to give next will you did that numbers issues and not have progression? get have assume due been around number, would number same ongoing on super of some patients the we a -- been patients reflected exceed talked will color product, time If receive trying there, the quarter-over-quarter be helpful. manufacturing there to as month-to-month i.e., XX there patient over whether attrition the XX be that you or patient sense that's the

Frederick Vogt

first, your saw second what clinical the we answer question consistent and patient in rate success the dropout trial with experience. remained To Yes. manufacturing rate

I fully for. currently but the data did answer your those to we second clearly that more set fact we a we're numbers. the more that And obviously seeing than in guidance larger feel pretty that. good then and So numbers. And now, that have XX that sit the today. of you so Part the go, we quarter quarter we're couldn't can further and quarter, we're once quarter already we quarter, that that third in, on this getting as can you're optimize out meaning we details in, that. -- in giving about patient We've we patients to with all here, [ working that, reason understand necessarily we question, done may We have ] reporting what right we're MMR provide see very on don't understand is that

quarter, sure to that higher. to again. such want by be if are I'm that much your or the to question numbers accelerate end considerably it the expect third if not We can answers of phrase going that I it the differently, try obviously you

Yanan Zhu

Right.

current this hard quarter, lot rate, given because for So there's this of Proleukin. the at given us this going gave the this understand only on. but Proleukin guidance, still a stocking And quarter, more So the have little quarter to a XX patients, it's revenue a assumption of just go, revenue I -- patient trying think for what's number that which you than for to couple this to that quarter, contribution you your infused is right? includes understand months I'm

the see us for number. to So it's patient hard

If you be this understand patient can that would the us quarter, help helpful. number for

Frederick Vogt

with quarter estimated that for restocking to that give this can't most Proleukin. will being of good number right tell number will way portion and have to you you today. Proleukin, the million higher That's you in I we XX. it a an that's especially $XX it lot the a can color that than now. give higher, I you it think $XX Estimated, significantly of I be can track we will out give out revenue track million

Operator

from question Tyler with next comes Cowen. Our Buren Van TD

Tyler Van Buren

Just a couple.

you would ] of consistent on time you infusion beginning what's to average you're then And XX% But much how ] second target gross gave of years. the the kind guide XX the over basically one X of X -- XX from I suppose few manufacturing, is from on infusion? So [ is gross to and in margins. assume time the margin opt-in list. which reimbursement. some around netting if That per next the to roughly [ metrics

has lower quarter. sales it the revenue be cost product for inbounds as being getting with we're of So and this some same to currently,

and over helpful. is variable that how So color super evolve more on and it would how fixed time versus much might be

Frederick Vogt

of calls line today, our whole process. to That's is term. right talked currently, it quite earnings case Tyler, X right wanted long the right? we and on where X-weeks now, getting well We to scheduling and about as Sure. approval, that entire we that's in see financial -- answers hope there. the all to resection. be for your endlessly about where question now, first single close the getting takes thing enrollment So part The agreement, reimbursement stuff The I that as

On you net about talking I'm the a obviously exactly are from you're is not about very of product Amtagvi? we've number on what netting, you and financial -- discounting, I low. the margin, product with you to gross on net mentioned asking to sure Because think to the gross the respect given perspective. Gross

Tyler Van Buren

you're much you netting quarters? how and currently, the coming how that infusion to in expect each Yes, evolve with

Frederick Vogt

All right.

and to expect X.X%. we net X.X%, there. less right less stay is to So than gross around it than now

Tyler Van Buren

of guess the cost But same as the sales are product is question I revenue.

mean a a lot XX% currently, gross is it's of fixed. half I margin, not I -- and right mean, it's there's So a obviously, -- lot if that X.X% currently.

Frederick Vogt

help comment? cost I need you have. Jean-Marc, sales maybe that want some lost of -- think -- the of I'm in do going Jean-Marc's probably so definition here, we is of to this this but is to

Jean-Marc Bellemin

trying Yes, to in and Tyler's just answer chiming question.

you the all in cost our what see will the in $XX So is is sales XX-Q and total obviously which detail of million.

other margin have If cost We don't sales, to that a note product total, or you will the course, specific of you but than of take you sold you cost cost goods to have account. account, to into royalty itself because things into have any year-to-date on at gross because for XXXX. look product-by-product just you have, only take intangible need assets it's of product, give of June that

XX% the we of to this So because sales us you in on gross of for the in cannot the for reaching XX% few terms again, we the next product, make we reach several exactly stand margin. But confident years. in conclusion years that the where committed, believe today next cost our what's do are

Operator

with question next Stifel. Burnett from Our Ben comes

Benjamin Burnett

To appreciate I product question do extent calculating congrats the the when Jean-Marc you just all -- that on progress runway? revenue cash great you were quarter. consider A again, cash guidance on And a on what the talking about.

Jean-Marc Bellemin

Yes. you, the with very revenue, are conservative. product Ben, into be We but take to we account honest do

all that's operational recent terms and capability million that into the our manufacturing go spend. increasing the spending in we saying why able wait just just confident be all includes terms to -- investment of So $XXX to And into XXXX. with we we're of in capacity and

conservative about confident very are and we very that. So

Benjamin Burnett

Okay.

of forward, we clarify, just kind product product guide? guidance so just that revenue to shouldn't exactly going spending about is guidance the that, assuming when the so assume thinking And -- cash

Jean-Marc Bellemin

We are look the around you, million for one-time But cash to at to into this may what XXXX After that. in for topline. we obviously, again, situation iCTC, next year. have baseline telling very our a do into as XXXX, take you into account overall $XXX expenses and cash that's the burn take capacity have some account, the is our in for million to But into giving capability confident into example. increasing guidance the also cash into $XXX we

Benjamin Burnett

Excellent.

the is just follow-up. X,XXX? And to expanding maybe for Okay. timeframe kind the What capacity of one manufacturing

Frederick Vogt

one? that handle to want you do Igor,

Igor Bilinsky

Happy to.

And iCTC thousand the So the network existing built couple within right a capacity. is to now, facility. year of patients per

capacity. build-out building a that have build-out you And in we're now completed As of and out couple recall, iCTC should will we bring X,XXX to patients that years. year over that per shelf space be

Operator

question Baird. next Our comes from with Kusy Colleen

Colleen Hanley

just be the guidance, on progress. is happens the rate and comment contribution manufacturing COGS? is you expected what the how Europe? on get then And the an Congrats filtered just into much of from Does to unsuccessful -- Can kind XXXX manufacturing for when there fiscal success year run? that of

Frederick Vogt

into a works that cost? you the with talk about want goes to Yes. how Jean-Marc, out-of-spec how and little an like manufacturing bit it do

Jean-Marc Bellemin

Yes.

So scrap of situations being infused that product our and other into see the of of out by Colleen, or queue because account you as patient the stage it take all spec in course, The part of spec, will cost like thanks health that for of when the question. the patient sales go production I appreciate not of have because what will and that. out we to is of it and was. the

is will we of situation, OpEx. into taken will part then some it of potentially clinical sales. of use, be into as and So it account its going If kind switch into -- cost case-by-case

switch as case. in our it OpEx to clinical spend part will back that of We

Frederick Vogt

will factored right I anything can that revenue now, online. not Colleen, in answer. And the European No, come is

my in and more expect give remarks tailwinds in little us will bit I even As beyond. later, a XXXX we said and

Operator

Our next Goonewardene Truist. question Asthika with comes from

Asthika Goonewardene

case going all proportion patience attributable XX with XQ? in color the shifted then the with then more the already that fixed these little of is Proleukin? of it a guidance right the ask each has give sought our that contribution I were basis? you to what appreciate assume that each all one the each this. And period can guidance -- the Or into Maybe on patients that on a period? of how on I'm and patients proportion to patients XX And today XQ, progressing Is that reimbursement is provided, the if product was period? component to in single and the color today slides revenue a treated down treated questions here.

Frederick Vogt

Yes.

you way a So you vials Amtagvi is fixed about to you're price going Proleukin has think as the referred price, combination, what to number expect, multiply get I of percentage. to it a think fixed Asthika, you the the is Proleukin to price, by has a which a

Amtagvi can percentage in those pretty total percentage cost patients you, out be Proleukin percentage contribute, calculate what calculate or could that do a but of the It's XX%. We contributes drugs, that get easily. you in the Amtagvi detail to X Proleukin, of what ultimately, between you more math. going So there's the roughly ballpark for about

little a faster. the how every single Jim, the XX patient. patients do case on agreements For and for for that help Maybe case just color is improve could agreement, we go faster those you single They add patients? XX bit

James Ziegler

Fred. Thanks, Yes.

prior the what to payer early days had mirrors currently of in launch, launch. we mix So previously we're seeing the shared that

mix and applied that's of we're private the to the recall will was about seeing of XX%. agreements now. In very prior authorizations months primarily payer so the patients. about you what consistent, right X/X our single-case which That's payers, So launch, early

Operator

next JMP. from Reni comes with Citizens question Benjamin Our

Reni Benjamin

they're great kind especially can bit less of how before it us. they're of Is with about as prioritizing a now starting they Maybe then the how Maybe at a a little slot little the you CAR were what I -- are maybe looking changed just for bit talk backlog? patients cells not a you infusion. and have A forward. And talk little you being enrolled? can talk then it maybe versus looking ATC or this a just couple and and about quarter were get enough process. how kind that's managing of lot as Are also, on guys get of with to there was we has waiting a argument any? heard bit and you quarter. it off, backlog Congratulations guidance. didn't about people as infusions there to a comes you're healthier, was dealing patients guess constraints lines dying -- great And that for how Ts and TIL Can going they other -- arguments that, therapy? working whether the

Frederick Vogt

the Jim, do second take maybe can the to Brian first you want take that, part? part of

James Ziegler

Yes. Sure.

Reni. So thanks,

allocate that As almost Amtagvi, we top but with ATCs, do I doesn't work beds that scheduling I'm sure for the we seem and be between ATCs, concern. work basis, how with not in terms the of, a them especially patients and daily know they a decide of CAR on exactly and Ts TILs to demand

there a at appear around as was of be any Just launch, beds, not of lot prior to type restraint to it of concern the all. does lack hospital

it where before patients dive say are launch would available you to same into CAR-Ts we're a seeing guidance. some our confidence therapy. those trends. fifth what terms demand that looks reiterate really that the not patients progress guess I at now treatments. other infusions, of dying do have or Yes, lack that well may Brian? is sixth better, really, But may high as and is the of similar unmet we I there's before need In into I would and patient just think much getting good, reinforces ATCs, the our readiness and the I and we're operational selection seeing months, the behind

Brian Gastman

it's get second I be is send the -- current all these what's selection, healthcare understanding speaking referring the understand it's so is peer-to-peer, partnership. its and would appropriate try One it to as kind. Iovance, send to can patients best and in even that really -- the rather about the journey earlier think --we their and commercial who which a assessing better that healthcare It's are more in to really patient And centers we've unique, right only former all up Jim. may best were you patient at not process call who think done their the developed everything it not earlier Yes. population speaking it's -- improvement biggest current candidates. We're made a doctors, they learned to as thing I one them to treatment them certainly I authorized the is out providers providers point so said, when patients to we've there. this patients are that people make most now the candidate. There move when we of

And describing. bear have is relationship starting treatment what we that's were centers I think I this and fruit. less all you're why seeing you with of think the less authorized to that

Operator

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

Frederick Vogt

commercial and TIL XXXX you the Quarter Iovance the Second Thank to cell for We're joining Biotherapeutics and disclose Conference Results for Call. Update again the first honored First revenue Half Corporate first Financial monumental forward further the Iovance. as in look on launch pipeline developments progress and future as well our a Amtagvi and therapy outdates. It's been our updates year of continued providing for to already

media, media We providing is metastatic continue with as to Amtagvi to be motivated we patients hear hope and melanoma. social

thank Thank you. support. feel As and exceptional healthcare reach our Please like partners our communities, and follow-up. thankful always, analysts our Investor patients, efficacy we for for to to team Relations to free out our are Iovance their for I'd shareholders covering also and the team.

Operator

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

may You now disconnect.

Iovance Biotherapeutics (IOVA) 8 Aug 242024 Q2 Earnings call transcript