IOVA - Earnings call transcript Q3 2024 | Iovance Biotherapeutics, Inc.

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Operator

Thank you for standby. My name is Mandeep, and I'll be your operator today. I'd like to welcome everyone to the Iovance Third Quarter 2024 Financial results call.

I would now like turn the call over to Sara.

Sara Pellegrino

Thank you, operator. corporate you our this XXXX third as as thank webcast call financial and updates. well discuss program to quarter recent afternoon, for conference joining and results Good development and and year-to-date

of on Affairs recent submissions Dr. Regulatory Officer and key Medical our cancer. our [indiscernible] Fred Officer call our will key of our President, commercial lung Igor will in Vice available our the a progress and an and cX Dr. at centers will Chief will cover Officer and adoption provide status guidance, Chief frontline Dr. revenue launch Financial latest cell financial and Q&A at of pipeline. access, to session. Chief Bellemin, Chief review to global Finckenstein, pipeline our Senior U.S. Operating capacity of and Dr. our and manufacturing our updates Officer, update gross Amtagvi the our Commercial highlights review our of as revenue Executive sheet; Bilinsky, results, launch including our growth balance related our experience expansion. treatment non-small outreach community the market and patient guidance, Brian program and Graf in margin of our Medical and including and summarize revenue for Vice Jean-Marc President, Perry, summary the also introduction our are clinical Dr. Friedrich EVP the with Gastman, revenue President, additional commercial strength ongoing advanced our Raj Vogt, or Interim authorized well regulatory the drive Executive highlight U.S. melanoma. Affairs, on Amtagvi an as initiatives ATC high-level will for demand including demand commercial

website our this release we can afternoon, corporate be found a issued iovance.com. at that Earlier on press

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

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

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

Frederick Vogt

Thank you, and Sara. a recent commercial advanced corporate launch I'm year-to-date of melanoma. quarter our with start approval following successful host results this strong the highlights. Iovance for the to for the to afternoon's pleased our financial Amtagvi end as well call as XXXX third FDA and year nearing first to patients of a of our is conference discuss U.S.

development current commercial are advancing pipeline opportunities. We our of future expand therapies T-cell rapidly our stages across all generation to robust

highlighting would continued demand I the begin Amtagvi. to exceptional by like for

third and revenue product $XX product the third in $XX.X the of Proleukin. revenue total our to product million, quarter included million total for Our Total was million guidance million. surpassing end $XX third million quarter $XX of for Amtagvi quarter top revenue $XX.X

upon for $XX.X infusion and product September a total Year-to-date, As million to Amtagvi the few revenue XX delivery typically is distributors prior to patient. upon was $XX.X months recognized a hospitals million Proleukin Amtagvi for Amtagvi Proleukin. recognized including $XX.X or reminder, million to revenue revenue is to infusion.

on adoption been XXXX and and million Proleukin April infused today, at third to of an representing in well second over infusion $XX patients adoption us rate Amtagvi. quarter as XXX in increasing to the fourth time track Third also reflects through uptake guidance of initial more of as and sales keeping first alone Since XX reflects towards robust and year-to-date XX in with come. have demand quarter used revenue the increasing date. with the Amtagvi Infusions Amtagvi XX revenue our quarter in Amtagvi from with XXXX with about the quarter, strong

successful ATCs and XX and the drive on treatment our team's by ATCs, execution year-end. Our a goal broad continue we melanoma, current to or of total remain XX of as onboarding and medical as need authorized strong advanced and access well uptake in centers Proleukin. unmet network awareness With ATCs, patient Amtagvi motivated focused of approximately high adoption expanding

additional driving also to treat are continue scale ATCs initiatives up referral to community demand as our patients. Our more

favorable clinical demand, are patients or Amtagvi. policies covered lives coverage have XXX and payers. plans. Amtagvi reimbursement lives private the or than Approximately of positive robust benefit more are U.S. to by pharmacy covered for currently through XX% broad to addition to trials of of Comprehensive than policies Network XX% medical facilitating reimbursement National with In NCCN and More medical access payer access coverage Cancer label has coverage been consistent positive guidelines. And million

manufacturing to summarize, demand can further patients increasing and capacity month while we an to increasing Amtagvi current will are and meet count head match Igor delivering growth. We at ongoing As each pace.

weeks, the speeding initial X As weeks days averages X initiating from currently prior journey Financial a in for with saving the approximately product arrival. and/or by of to in [indiscernible] financial additional reduction preconditioning the patients. are up launch regimen also several ATCs continues, representing clearance conjunction parallel treatment with time X significant scheduling launch. to is clearance

consistently and continues. turnaround are days decrease launch our to and on We the as turnaround testing this time XX of time delivering for manufacturing expect release

guidance year $XXX are million. total of full to $XXX revenue we our reaffirming product million XXXX ahead, Looking

$XXX our million year guidance XXXX reiterate product to in of We million $XXX full also total revenue.

as contribute ATC's utilization expect as demand. year-over-year significant additional We community referral ATCs in increase networks well a growth as and to new broaden

is $X billion revenue address to market. represents XX,XXX advanced more peak than multibillion-dollar additional more significant melanoma advanced opportunity beyond. U.S. melanoma and Amtagvi In a previously education the target. in currently in over highlight a our And in Proleukin years. anticipate XXXX markets. than next and the U.S. few gross the our Jean-Marc Amtagvi opportunity in to the initial represent several XX% treated which third than will ex more We to patients towards halfway margin, margin minutes, also that than alone, annually growth increase quarter Globally, and approved expected greater in is U.S. Gross

and to a integrated [indiscernible] positioned in U.S., the Iovance well infrastructure With scaling fully Amtagvi outside interest continue globally. is

Medicines built Agency the plans a all marketing in MAA, markets separate second review, United of with XXXX. the a XXXX. with states first application, being our is U.S. submission validated authorization accepted and ex reviewing the ex for approval Healthcare regulatory U.S. dossiers potential EU Kingdom our multiple in European half of half for or half review are of Our submitted international across first first teams are and under and for our for potential Agency approval the member in potential Medicines MAA Products Regulatory in The approval XXXX.

is near-term Our new include potential for will process also submission and a for review in Canada drug approval prioritized submission mid-XXXX. underway in

in additional in [indiscernible] and of Additional highly regulatory submission the on concentrated melanoma remain we'll Australia Switzerland future. target in patients and with populations markets advanced XXXX, track for

in TIL therapies leader Iovance innovating, is of the patients cell global for cancer. and future to with remain generations delivering developing poised current and

drivers label with our The property intellectual in types together global distinct pipeline melanoma, today. first manufacturing with discuss we'll Future advanced us the growth more advantages. programs large-scale position in approval, and TIL provide and competitive include frontline launch other in next-generation cell with tumor expansions deep detail therapy that

who Medical our now to Vice Brian, hand field Affairs, U.S. in network of Executive I'll will Brian? President our ATC over summarize activities.

Brian Gastman

the potential about patients lives Amtagvi Fred. of Thank melanoma. for improve the excited you, with thousands advanced We're of to

Our benefited are Amtagvi ATCs targeted and approval. to feedback our ATCs support adoption highlight: one, objectives utilization our two, today ATC continue My and patients network; stories about who community to oncologists. as field as well share have for and across since positive and expanding from their demand

to goal States in to ATCs, and our reach our access. scaling with end the growth NCCN early market combined ATCs network and First, XX is expanding more continue. is at and by approximately Today, robust broad data, Amtagvi's XX has inclusion to with available planned, come total the guidelines, clinical we strong of as in XXXX successful and demand ATC expect Amtagvi XXXX. supported United is

team highly providers, and Our of and and peer-to-peer each and ATC science provide former surgical oncologists successful Amtagvi health and They selection conversations medical composed medical including treatment care liaisons experienced proactively unique training maximize resection needs outcomes field support, the regimen. is the of surgeons. with patient to around understand

than by treatment closer within will an bring all to patients, located more a the of are center network to miles closest of ATC within treat our be to melanoma patients XXX year-end. Nearly ATC patients XX% today. drive expand X-hour we As

community-focused networks early by Iovance our be are demand community also patient treatment professional teams primary top of and and is who may eligible practices receiving objective referrals patients driving across targeting disease progression. are melanoma organizations. referrals Amtagvi drive to growth volume for large are and advanced The frontline upon currently with field Community currently identifying ATCs.

Operating with and our extremely highlight I manufacturing utilization the successfully performance launch to ATCs of now as Chief progress. In broadened to early pleased Bilinsky, are call Officer, pass our Igor summary, will we adopt Amtagvi. our the

Igor Bilinsky

commercial status you, of progress to ongoing capacity Today, of manufacturing commercial the Brian. Thank and launch our highlight clinical expansion. our and facility I'd like the our capabilities and

commercial up the ramp demand. steady Amtagvi support its continues capacity manufacturing Our month-over-month to growing

well as staff supporting We ICTC manufacturing and launch hire our as February. increased in at have quality staff since functions Therapy control capacity continue to [indiscernible] significantly Center, or actively and

internal the by Philadelphia. facilities Navy cell many too FDA one One of have largest manufacturing the our the is located therapy Iovance is the Yard facility, We Center manufacturing sectoring world. in Therapy facilities commercial Cell for in from of It approved Amtagvi. manufacturing

scheduling us Amtagvi In serve capacity with facility flexibility further manufacturers our contract and addition, to patients. provides

tremendous contributed best prior among selection We commercial remains The rates. is team and for procurement which as such optimal sharing sample tumor manufacturing to which ATCs with to consistent date, are medical improving doing experience. clinical job experience a manufacturing, our pleased affairs success with manufacturing practices

receiving XX turnaround consistent cells to The from being the facility ready to has at Amtagvi at for the shipment ATC. manufacturing time been days return

working time. processes mentioned, the optimizing our turnaround on Fred As to shorten further we are

scale we competitive through our as we by advantage expect of therapy as to up, goods leveraging also and TIL over scale position time cost the As the well cell as of the unique operational space. in and improve leader efficiencies economies

availability running currently capacity at ensuring is ATCs. network manufacturing small utilization our high while for Our

of global to In in and well. commercial are a outside markets new in product clinical sites launch anticipation of geographies, Philadelphia potential trials and successful the our U.K. serves Europe, Australia EU, as our the and Canada. as distribution we intend ICTC in to and already manufacture approvals such establishing support we patients U.S., other Amtagvi commercial from regulatory logistics The

network. ICTC longer-term is we and In built the other is ICTC expected melanoma the patients bring demand we to expected for our growth products patients process over than patients expanding to over capacity existing today automation manufacturing of shelf manufacturing capacity has a in is TIL commercial provide space anticipation more optimization out the within that along of of expect couple Further our upon completion, annually. Philadelphia, to at indications, X,XXX and Building are capacity expansion X,XXX which annually. of annually in to years. XX,XXX with campus to the bring global

time supply and to manufacturing their Amtagvi right serving I'd XX/X, doing is paradigm-changing chain like dedication, continued to out patients providing first operational for team therapy. them Iovance thank in meet in excellence every the and life-saving patients spirit to The committed this of potential who XXX in quality everything time.

our TIL-related Importantly, are U.S. currently protected and property XXXX. expected owns for in patent technologies as portfolio. TIL through granted exclusivity than more by provide as at Iovance international XXX are other manufacturing cell robust rights allowed expertise a and patents that intellectual Amtagvi and therapy well or to capabilities least

questions will Officer. Q&A, hand to available Financial Jean-Marc, call answer I'm I additional our during now to the Chief and the

Jean-Marc Bellemin

our Thank including as well current guidance cash our results review revenue gross quarter as as you, our September Igor. I expense well financial will XX, as XXXX. our third Today, for position and outlook, I months the ended and X margin. will highlight also

$XXX market approximately facility was $XXX.X the quarters equity XX, [indiscernible] million of including of unaudited XXXX. and early proceeds third financing approximately the XXXX, September million, second our position in As during net cash

be expect current sufficient We to the position product current to into and planned cash operation and fund revenue XXXX. anticipated

share compared transition of for share net was loss ended million or will I Net quarter per million third $X.XX $XXX.X $XX.X now quarter per the loss financial results. our XXXX or a of ended third per for to September to the the September X-month $X.XX XX, of loss share first $XXX.X months compared X XX, a the period for for million or net XXXX. $X.XX was per XXXX Net million or loss XXXX. share of to $XXX.X $X.XX

Amtagvi and revenue, primarily infusion in and total clinical used U.S. Fred revenue settings. global commercial of Transitioning our Amtagvi regimen and includes in the which the to previously sales summarized, Proleukin product treatment other

is distributors anticipated recognized advance infusions delivery As generally previously in and revenue of months and recognition. to upon revenue several Amtagvi discussed, Proleukin and purchased hospitals

XXXX, of Total million $XX.X first the of product respectively, million revenue Proleukin. first quarter Proleukin. XXXX of third was the million $X.X revenue and $XX.X Total of for million for $XX.X for including was Proleukin. and $XX.X $X.X for $XX.X consisted Amtagvi for X months X and of XXXX was sales and for global X million the for Amtagvi million and Revenue million, months product million $XX.X for

demand related were Amtagvi in attributable Revenue XXXX to increases in commercial the XXXX. Proleukin primarily for both strong with quarter use periods the the of year the prior period U.S. second beginning launch of of and for Amtagvi over

highlight September overhead and and with of sales manufacturing million period includes cash million payable well value $X.X patient noncash Proleukin will in X sales asset directly amortization including to for $XX.X cost Cost million as for that million noncash sales, royalties I of and success drop-off rates, on of the are inventory, primarily $X.X $X.X expenses months now product Amtagvi. cost of of and with manufacturing ended attributed associated as related market intangible and sales. expenses our XX, XXXX, fair which associated Amtagvi cost and step-up in was costs

drop-off of cost ] intangible million over has sales greatly X-month to success noncash Cost with was of even year X noncash and fair increased. in months amortization In volume associated our $X.X rate sales. decreased success though in $XX.X report primarily the royalty assets associated Notably, sales and manufacturing [ to primarily third period, assets. and rates, patient quarters million activity patient previous prior the million, step-up and cost quarter $X.X with million of certain was XX, manufacturing amortization related expenses for costs product related payable on drop-off September million million intangible for market ended value $XX.X XXXX, in and including $XX.X $X.X

cost noncash prior quarter the sales of increase cost third primarily were was year related the In in over X-month in of assets. year-to-date for The prior and million, amortization intangible $X.X period, primarily sales year to period XXXX the attributable well and of the sales, to noncash Amtagvi to first the of the and as XXXX cash initiation sales including related manufacturing U.S. in increased expenses quarter of product commercial as Proleukin. commercialization Amtagvi tied beginning Proleukin, of related and

volume of Since increase of as up. sales Amtagvi, the initial cost due launch is improving to capacity utilization demand ramp and strong continued launch we and

as as translate with addition, education on operational optimize of and over release focus and as the ongoing our sales and time. margin support, cost mentioned, Igor higher Brian manufacturing ATCs can testing in continued and well to gross training a In further efficiencies

I gross will margin. third on briefly quarter comment our

to million. in [indiscernible] $XX.X the the third reflects focus third the related and amortization against gross market gross in us coming of XX% fair and sales such on over acquisition, $XX.X million includes of gross quarter of more our Proleukin margin years. a of cost quarter a quarter target noncash positions profitability our as margin $X.X million value towards improvement expenses in Our above of in margin ongoing second than revenue the the resulting The

in of offset year related lower expenses activities research of third manufacturing the XXXX. third compensation. to and decrease $XX.X transition development same for the decrease in development the commercial and including resulting XXXX. September stock-based million ended a The to our were over the $XX.X XX, period X of period million of qualification XXXX. and to $XXX ended the quarter the million costs shift now pre-commercial count completion X will for and by expenses. and to September decrease ended were the in months clinical XX, first XXXX, partially the were costs in $XXX.X XX, XXXX attributable increase development and and Research million from in and expense compared prior months September development This million for compared decrease quarter period were for $XX.X primarily lower expenses $XX.X of a XXXX, same operating research to Research costs, Amtagvi I of million head

to and period an $XX.X $XX.X to compared million increase an increase million of the of XXXX, general same compared expenses $XX.X were expenses Selling, for X-month XXXX. $XX same of ended for administrative general first September Selling, quarter million million administrative for XXXX, for months $XX third the compared the administrative as months million quarter costs. infrastructure $XXX.X were million year period XX, of X increase the primarily stock-based in period X our to XX, September related cost first and selling, to of related the ended support and well the growth attributable count to third in in expenses XXXX head business overall legal The and including as compensation general and prior was commercial-related and increase XXXX. costs, and

to summarize I ahead, Looking outlook. like our would financial briefly

mentioned, Fred $XXX our within the year $XXX million XXXX year to for XXXX. to the million of for the million $XXX of we total As for $XXX full revenue range product guidance reiterate million full and

Regarding expenses, $XXX burn the $XXX we of full excluding XXXX in onetime million our range operating year reiterate guidance to million, expense. cash

opportunities optimize coming leveraging will in also We spending quarters. the keep to

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

Friedrich Graf Finckenstein

Thank you, Jean-Marc.

cancer is endometrial cell XX% Houston. Meeting for next-generation which Today, Immunotherapy Conference, and our the melanoma are attending as diagnosed frontline Cancer lung, in solid iceberg programs than SITC clinical Amtagvi cancers and all have of tip we week, our the U.S. in in Society TIL therapy As or pipeline. This of in Annual well the tumors, on exciting I my the of more potential focus only represent as will colleagues conveyed for the

Here, are lifileucel results is we patients patients cell inhibitor who XA updated therapy. I'll trial, review late-breaking ORR, are presentations we have disease from preliminary with of and non-small focused checkpoint who the non-small including these disease, and in In rate, naive our frontline Amtagvi in Cohort and longer-term in among on presenting confirmed investigating negative PD-LX is Cohort regardless setting. therapy. wild-type the a ORR have and analysis follow-up. XX.X% of cancer number the XA these invited IOV-COM-XXX than responses to who of or Cohort cell pembrolizumab poster, additional pipeline. PD-LX majority plus patients of XA represent approved advanced with patients reported including objective patients, patients to the difficult-to-treat in cancer which XX.X% currently status, was lung response higher The EGFR lung patients

Remarkably, X XX more last wild-type from with for of as visit, TIL X months the ongoing in ongoing X were tumors follow-up EGFR than responses of the infusion.

XX.X In lysines duration the demonstrate XA median and response Cohort at reached to The treatment. median months. well cancer poster for was addition, of are for study available potential regimen benefit standard non-small not robust drive response deck lung of late-breaking the follow-up frontline our as rates when in meaningful a durability care corporate as The in meaningful cell added of iovance.com. to results the at

will will cancer. lung the that lung a patients IOV-COM-XXX planned Based cancer. lifileucel Cohort design Cohort a non-small we confirmatory plan non-small XA clinical of adds the results new Cohort regimen on EGFR cell to pembrolizumab wild-type data, XD XD XD of in of care frontline open trial Cohort inform the cell chemotherapy with in standard to investigate and frontline a for trial.

of cell a efficacy chemo in that lifileucel augment current XA the lung regimen expect has potential the frontline in new into strong and further with and to regimen non-small the will integration frontline pembrolizumab cancer. of the establish seen Cohort standard care We

to need single-arm with the about chemotherapy, cell duration with non-small [indiscernible] for cancer we're To enrollment accelerate. address medical opportunity standard current lifileucel to in registrational IOV-LUN-XXX advance patients in clinical and continue monotherapy Investigators the investigating of lung the are Phase patients responses. the advanced II setting, unmet Single-agent among excited limited and and care IOV-LUN-XXX cell lung the of this post anti-PD-X setting first provides non-small rate trial. cancer the therapy trial. in

our preliminary We data IOV-LUN-XXX. based are in feedback prior the confident also for positive strategy approval on FDA and

data and additional potential cohorts cell lung the expect achieve lifileucel to U.S. registrational non-small XXXX, cancer We accelerated for XXXX. in report approval in in for a

for priority a opportunity top commercial at the melanoma into Iovance. also Expanding Amtagvi advanced frontline is

regular TILVANCE-XXX to melanoma support Our on global and Amtagvi Phase Amtagvi pembrolizumab full in as accelerated advanced of anti-PD-X remains post in approvals III of frontline registrational approval trial combination and melanoma. track with as well

continue additional strong XX sites across sites. XX momentum enrollment America, currently countries to and to active XX clinical new -- are among with XX are XX sites more We and across lined enthusiasm in Nearly Europe North across sites high And than Australia. see join up countries TILVANCE-XXX.

by from supported results Cohort is with TILVANCE-XXX inhibitors. patients naive reminder, a melanoma immune advanced IOV-COM-XXX XA As checkpoint to in

checkpoint presentation an the as including Cohort recent combination well demonstrated response In most data rate, is responses, from inhibitor unprecedented complete depth and at ASCO, rate as lifileucel a Xa a safety plus differentiated that confirmed therapies. XX% profile pembrolizumab durability of

In relatlimab for we alternative in and nivolumab best-in-class XD will the in advanced Cohort in frontline exploring a with the melanoma. combination in are frontline patients patients lifileucel trial IOV-COM-XXX and addition, investigate with U.S. physicians potential

Moving along the pipeline.

of manufacturing combination patients mismatch data have in therapy. is oncology of about after progress. with cell which gynecological positive by new from feedback standard well in commenced investigate experts. chemotherapy unmet created success with both as trial or Recent IOV-END-XXX our anti-PD-X chemotherapy and for frontline excited anti-PD-X, first proficient in as currently This trial lifileucel advanced MMR-deficient need has Patient immune enrollment approvals and published TIL preclinical in care repair trial endometrial cancer. for II therapy approved Phase after inhibitors a our opportunity supported and are to for tumors. of patients an are endometrial therapies There checkpoint significant cancer who We no clinical frontline represents

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

in AEs. IOV-GMX-XXX Phase associated short- adverse clinical using trial. PD-X modification in TIL long-term which inactivate enhance inactivated talent cancer I or The is IOV-GMX-XXX melanoma trial. PD-X next-generation a advanced reason with has interest enrolling of patients Phase anti-PD-X by technology investigating efficacy of XXXX. this increasing, the to II events and previously cell and high this continue the the contribute therapy, is or to pace enrollment IOV-XXXX trend are the may cell is to of to systemic with of non-small place through Genetic treated cleared with X is IOV-XXXX safety therapy, currently cohorts and We systemic lung investigators expected

I/II Building on our successful support Proleukin characteristics may proliferation. profile pharmacokinetic franchise, IOV-XXXX as compared a TIL trial enrollment in second-generation new better regimen to modified pharmacodynamic clinical was treatment to IND for IL-X application and and may survival drug the use Proleukin. for An Phase is to and expected and frequent investigation result allowed in analog favorable IOV-XXXX a or a TIL designed to proceed soon. of cellular begin enhance on clinical dosing safety therapy less IOV-XXXX

prior IL-XX tethered IOV-XXXX, studies cell ORR and TIL therapy. demonstrated melanoma inducible IND-enabling engineered The of ] doses impressive genetically TIL lower IL-XX a XX% are at advanced products. XX patients proceeding for TIL XXX-fold generation conventional to an than [ in Lastly, product

tumor beyond cancers with product ensuring market generation current tethering doses into pipeline the the in and our expansion common to IOV-XXXX efficacy solid while a IL-XX TIL tumor allowing includes inducible the safety, prevents for to IOV-XXXX However, expression IL-XX, product cell IL-XX [indiscernible] resulted secretion. potentially opportunity. of secreted cell the prior events. wide adverse allow range surface, which restricted improve over design to IL-XX which significant and of higher

be in year will submit IOV-XXXX featured with will IOV-XXXX in Saturday, SITC clinical be solid supporting We on of a unmet X. SITC Saturday, results development to need on common November poster post-trade to support results in for a Preclinical populations tumor cancers at request featured a to pre-IND in many large plan FDA Preclinical IOV-XXXX and meeting XXXX. this November X.

scientific and these details on press and I as Q&A view publications during session. about additional happy I'm as programs our in the to page data available currently and on release deck, to well are website. questions presentations trials mentioned address the Additional included the slide corporate the about development are today's our programs presentations

we to acknowledge and what's partners. would I'm year next the talented continue to therapy multidisciplinary with our to the significant our pipelines have the progress turn see I'll advancing preclinical I to call research over team this as in the clinical like begin and patients question-and-answer excited made and in and cancer deliver we develop and operator tumor additional cell TIL session. to additional settings to types. now thank therapeutic

Operator

[Operator Instructions] the Van comes of Cowen. TD Our question Tyler line from first Buren with

Tyler Van Buren

and Congratulations on the quarter progress. the all

So to last the same the date at XX% infusions XX above reported treated the XX point patients are quarter. time

you that sales stable, if so guidance. And obviously just annual should meet apply are and simply Proleukin you sales to QX to QX your

However, holidays up next coming there quarter. are significant

the about So the talk impact have you infusion can potential And of those yet? holidays any holidays? you seen scheduled around

Frederick Vogt

to to advance. can And over about far quarter, We project out we time to reasons see infusion as ahead for the in get put to be entire of their as wanting or either during physicians try -- their course, or actually family the the the to off. bit. talk take yes, going and infusions of can there's that we holidays the get patients Tyler, try that some a to Yes, to holidays infusion after well carryovers holidays, them

So there there law. is any you've period, is bit a during a think of what but of I regardless fair estimate that a lull calculated

think quite still quarter. that well when we'll projections. the for perform accounted I we our do We've in

Operator

Our next from Lawson Peter of the line comes Barclays. with question

Peter Lawson

IL-X of change assume can of like kind does think around for through number question dynamics and then of be level? just how if level. stocking over the but Kind going you IL-X walk a I time? use the I there's the to just what you of less kind guess that will stocking both look stocking quarter, each

Frederick Vogt

currently the Thanks, of on and focused in specialty level stocking distributors, we X in in X represent -- we United distributors Peter. The QX. the States, X another expect QX, in primarily X X large another we're [indiscernible] which be QX, there'll

I or up could steady. be as think, go said numbers the down, XX% so. will They I before,

less after Proleukin the did XXXX the that do quarter. quarter-over-quarter. as advising quarter, we stocked anyone You main said and after And see start we'll be more. distributors that, But I call, more to can We we last see. do quarter, for we then this we we'll growth more and up. up fourth thinking can't the case, on traditionally in expect did would have strongly more that, I've last all earnings go in the may

Operator

comes Andrea Newkirk with next Goldman Our Sachs. ] question from [

Unknown Analyst

sometimes ATC. Fred, more that you at actually if arrives happening comment provide could your I the on is in was wondering preconditioning parallel color before Amtagvi or

how common is. suggest to do such are that sufficiently this out spec Just risk? willing your this rates ATCs this at And manufacturing that improving curious does are of

Frederick Vogt

that's Yes, both a well are lot specs The getting more with and as comfortable if experience out of ATCs process as this. patients that doing and more Andrea. right, of manufacturing are have their our

correct message out patients majority because we don't see what everybody probably really number I tell is more know. either can't a have are you I product yes, you're common that that of is know but reflect how common of kind tell more [indiscernible] think a does as can't the is launch, that sophisticated you So I that I good experience, the many think confidence. in that I the this significant getting can minority that it for exactly we'll quarters we more go are ATCs larger patients. is. that guess, What of at I the it's into better. time

lot generally. do a want the there's confidence to think I of more full this they'll So

Operator

comes question with Yanan next the Zhu Fargo. Wells line from of Our

Yanan Zhu

into quarter, the about that mainly may, on across wondering center is in the -- like month-to-month quarter. and growth And about how trajectory prospects? XX And there elements distributed comfortable demand that quarter. clear How also is and number I month-to-month of feel if logistics are makes the going ATC growth, of the they Congrats wondering infusions Or are you the I you forecasting and increase? -- the how from there manufacturing about do growth? growth are fourth months? a was last they improved any

Frederick Vogt

reported. With ] respect the XX Yes, month-over-month, [indiscernible] ATCs about we of up slots your [indiscernible] there month-over-month QX growth already whether by quarter, expect availability infusions above [ in basically driven drives and that in the that's big driving in that. growth demand factor the adding to to through all, question that, or ATCs, was what that a and with the continue of growth, ATC that's new third meaning we've

the up So that scaling that it capacity. manufacturing manufacturing driving is we're up links growth, what's really fact the with

and and think a And beyond. Now with expect I can continue think happening. our getting quarter-over-quarter, month, add but can't it's I since better month into better asked, you I say rate. yes, that's I over out-of-spec XXXX that to I what's we're

I'm that growth, you some continue. like we yes, driven largely expect stuff out there's an also rate spec see to element So of by it sales. capacity, sure approved adding the to of month-over-month, and but -- of It's and wins element

Operator

Ben line with from comes Burnett question next Our of Stifel. the

Benjamin Burnett

what that? are just Just a goals, And I XX%. question that getting will you sounds the on mentioned guess operational XX% you like halfway to to are of profitability the you It margin How goal? get the realizing kind that gross there. you you're levers and think where

Frederick Vogt

I then a bit. start, jump and and Maybe little help can Jean-Marc can here in Ben,

launch, we on utilization. using So quickly the facility, ICTC especially capacity our COGS just down up as very scale goes the

that work other includes lot So excellence, margins will all have right are where to now, of from XX%. the in right end initiatives, drive that's the of A things margin major that component filed obviously, those manufacturing up a things things to is operational and to big up confidential, closer to which gross cost, up. that scale our of improve to we conduct the we they the of improving do be in major got a of use some quite the FDA process do things some component somewhere to a things but that type This We've takes with all also of progress day now. improve at sales in that's including to through, they're projects are because we mid-XXs go factor margins. cost sorts time that and

then keep of as portfolio. we that as at down our think of add may have able bit those those a I to And We well. the good on too. try expand more accounting to and least we expenses, our even pretty be Jean-Marc, side little bring steady management clinical

Jean-Marc Bellemin

cost you over about the Fred. I Yes. No, think I sales you improve then to said cost expect And the -- sold of think mean, the mean Thank you, all. of if in it I margin, goods do general we time.

in launches. quarter are We second of the only

our the QX is related the optimization, of a from obviously, QX, of there ICTC happening. as cost. future of the of gross the that's -- And with sold our terms some materials, as control in and in being So Fred, currently lot working on of the of mentioned having the jump even that improved of which seen automation, -- optimization, [indiscernible], also we goods to know by is by beauty margin raw you and and charge cost have costs significant own between in

are that's into future gross confident why go and XX% in -- the to So we XX% margin expect the above years. the

Operator

question Our of David Dai the comes next line with from UBS.

Unknown Analyst

rate? [indiscernible] improve our drop

Frederick Vogt

caught please part of got that, that you question? -- only repeat We we David. Could .

Unknown Analyst

apologies. My

are about saw What curious to quarter? some the of compared improve activities that just the dropout dropout the you quarter to you rate this rate. So last did

Frederick Vogt

I think don't really did anything particular. in we

are to better go. teaching get We're patients them we optimizing teaching do to surgical as better. We're the how resections. how launch quality through We ATCs

launch only script we part of It's really Brian's heard benefits You lot launch. of include seeing from But the of only all quarters think, a script. the I the just that of that's in ongoing. the the in X us are,

or that during we'll get at we to expect had I to what up success think that So manufacturing can quarter-over-quarter, we eventually you had see be the improve least manufacturing experience this think studies. we rate clinical and the will

did that I board. optimizing there's no, point So we nothing across to specifically. really the just We're can

Operator

Our Jefferies. from Yee line of next question Michael comes with the

Michael Yee

weeks I if more Fred, case that Can know in how remind wanted work than wondering deals. I'm remind be approval us or month. very it just been you about can you quickly business? a reimbursement. you single could it does you the that's how by of since accelerator of significant a can coverage -- for broad-based rather it's a days get sort where contract commercial, launch, patient that's going if and

maybe question you could just draw second is in lung line, ongoing study pivotal relates just year, the read us Can that something cancer. possibly second to rightsize expectations? The my that out remind next

Frederick Vogt

Yes.

time agreements. reimbursement, for well prior point down as That's reimbursement like the to the think, the probably, sweet ATCs spot can weeks, stuff noted news prepared we includes at good capacity clearance the That's and there even typically time on room the that given the room back forward. operating of their pack weeks. a do. which takes remarks the site high patient did we single time going really they cut to The authorization what weeks, select about schedule So realistically in, operating we manufacturing and bring the X during can as -- the financial that is X like X average That's parallel speed, case that. we have X

drag So think -- don't all. further to needing I don't it really that. optimize it's anticipate at really a We

but going that optimize, I where see we take a already [indiscernible]. one. can really helps not you really other slide a [indiscernible]. If that's you'll look think we that that today, where areas summarizes deck that on I We're think, we're and corporate new there, posted highlight our at this

about we us on today approval getting it's in can us release that's the think out what running study as XXXX, talked right baseline data year and having happen press now. Our XXXX based next data

Operator

the from Truist line of comes question with next Securities. Asthika Our Goonewardene

Unknown Analyst

to you've trends coming to number getting that just particularly wanted and I'm -- are I out-of-spec just of of producing much And and [indiscernible], outperforming new you centers patients, resections any a right out of influence the better improvement that rate. wondering case? quick seeing experience? good double a treat several that had getting there product the now on you are the factors just centers online it [indiscernible]. or centers better is more now having factor the Or that the are

Frederick Vogt

patient Brian's team make would others, here. and surgeons, is momentum think talk I stepping Well, go oversees they early don't the ATCs with select does They Brian come had we good that the from on the got what that that as work as up they that each just the patients. well scorecard to struggle faster patient-by-patient rush going new that the -- they and we're now at out a team plan charge same and how to for -- learning that them so correct they help team, And are on and with selection gaining the oversee been performing, momentum to they're is and and we as I learned resections look beginning, do it's some teaching both. that team We're the better. -- run It's them benefits them and were for and they ATC, ATC now help that that our faster. just mistakes. and make they and out a and of give And -- see did. resection centers them We peer-to-peer trying say sure big the to up all We Fred's out. actual quality. building along and they and come

get any to once do hard skills what But think There's we're I really magical these that It's ATC can really nothing work. the to seeing it's therapy. is get [indiscernible] it. Amtagvi and experience,

Operator

session. Interim today's would Thank you. now I the over does remarks. That for turn CEO, call Vogt, closing to to like conclude Q&A Fred

Frederick Vogt

and motivated continue in for update about already to future. It's again and to the frequent continued melanoma be in Iovance, as commercial and Amtagvi feedback We're the finding to updates ATCs the you financial in Iovance year-to-date from the setting. Amtagvi launch a results launch XXXX corporate of been TIL and update Thank call. forward commercial benefiting hear look advanced Third year pipeline as Biotherapeutics our hope an transformative developments as we we on joining cell near our further and conference therapy well quarter provide providing first with pleased patients for

to health and thankful partners Iovance the would shareholders patients, thank you. team. and for As our care advocacy our also communities, their to exceptional I our always, support. analyst like and Thank covering we're

Operator

conclude today's does This call.

You may now disconnect.

Iovance Biotherapeutics (IOVA) 7 Nov 242024 Q3 Earnings call transcript