IOVA - Earnings call transcript Q4 2024 | Iovance Biotherapeutics, Inc.

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Operator

Good day, and thank you for standing by. Welcome to the Iovance Biotherapeutics Fourth Quarter and Full Year 2024 Financial Results Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Sara Pellegrino, SVP of Investor Relations and Corporate Communications. Please go ahead.

Sara Pellegrino

operator. you, Thank program welcome to and XXXX Iovance call and conference results Good our to fourth webcast development corporate recent discuss well year quarter and as afternoon, as the updates. and financial full Dr. Fred U.S. provide the introduction will and an Interim Vogt, with and our Chief our progress Officer President, Executive latest summarize summary key pipeline programs. commercial launch and revenue our including revenue guidance of of Amtagvi, and a high-level outreach centers, initiatives market Dan drive Kirby, access adoption, or Chief ATCs, authorized at highlight for community Commercial growth and treatment to additional the Officer, demand will U.S. U.S. commercial launch our as as well ex launch expansion plans for melanoma. Amtagvi in advanced Dr. our cover available of experience, Operating Bilinsky, Igor the ongoing our Chief Officer, our commercial status and capacity will manufacturing expansion. capacity staff burn CFO, financial of review our strength our and our results, balance Bellemin, sheet. revenue will and margin, guidance the revenue Jean-Marc cash including guidance, gross And Dr. Graf cancer. Chief our including non-small X registrational key Officer, and in summarize cell our will advanced Finckenstein, Friedrich melanoma frontline programs lung pipeline programs, Medical

including members Executive team, Additional this Gastman, of our release question-and-answer issued the available afternoon, our iovance.com. President that Affairs, session. Earlier we our at found a Vice of will corporate on be for press be leadership Dr. can Brian website Medical

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

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

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

Frederick Vogt

Amtagvi, Amtagvi our corporate $XXX.X Earlier future financial anniversary pipeline to results U.S. this year all pleased Meanwhile, marked in as gained the to generation recent reinvigorated X-year quarter we in Thank and and anti-PD-X development launch In cell full thousands full therapy month significant markets. afternoon's launch, for following growth and of our to a appropriate XXXX in of for FDA-approved of and tumors. Today, targeted cell solid in Proleukin. to quarter treatment revenue Total and million of highlights. progressed new tens I'm conference current patients TIL for therapies growth fourth approval executed product this in robust host address the patients our Iovance treatment and the advanced $XX.X Proleukin our efforts year Amtagvi global of across the continued highlight fourth pleased I'm advanced you, XXXX. the both to discuss of commercial call sales and the traction product with the Sara. fully as was total transformed melanoma we well with a revenue therapy. the stages of million historic start first We XXXX, company. strong into to TIL first

the $XX.X achieved revenue finished we full consensus. $XX.X fourth for Importantly, our above Street of million million $XXX.X of and year million the Amtagvi $XXX year the our with for full in revenue $XXX million million, of Proleukin million year and quarter guidance upper period. Total Proleukin to and XXXX Amtagvi for $XX.X for full range the end consisted in

XXX with than already patients year revenue treated year in partial reflects more the Amtagvi launch. product first of Our full

Amtagvi sales. well momentum as We in strong are pleased and uptake Proleukin continuing with global initial increasing robust for the as demand

ATCs continue network well high broad expanding of and and awareness, centers increasing melanoma, drive for a Our advanced patient in as access to team's or unmet demand motivated successful as the Proleukin. execution authorized Amtagvi need treatment

back in Our manufacturing for capacity scale These focused investment additional treat than Today, staffed supply anticipated and we last ATCs growth. demand of referral year, network global patients. up the and scale we driving X,XXX for more half Amtagvi. current in additional are is augmented U.S. to the have efforts in to at they the In and as to our initiatives. more targeted up our continue field community demand to launch supply patients prepared well per year

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

a in Amtagvi networks through as and contribute as expect referral ATCs in utilization, demand are Proleukin new community expected ATCs significant to year. We both growth well while increasing increase as year-over-year broaden the

our gross quarter cash towards And XX% improved years. also over onetime decrease term, and surpass expect sheet the our margin and target excluding XXXX well fourth continued is and margin halfway and balance burn, XXXX future significant several launch and breakeven annual burn to Longer towards to we were in quarter-over-quarter the profitability. increases already indications managing in revenue correspond gross remain and our beyond. significant confident again next continue a in pipeline in Our items, We in growth cash maintaining execute products. drive decrease and we of will to our as in with judicious over revenue while

more sales billion alone globally. and advanced is For in peak more billion melanoma opportunity $X indication, $X the the than approved U.S. the market than currently

gain expansion types markets. advantages pipeline. cancer and frontline and into the melanoma, Amtagvi manufacturing non-small Future first competitive plans Our therapy launch to expansions new access are distinct other provide launch cell on and solid ex advanced cell lung of Iovance approval track in several early in growth such next-generation therapies. include with TIL drivers intellectual with the U.S. positions X approvals has as new tumor large-scale potential combined deep strong with property label global to a

month us and commercial I the the call Dan of welcome his this Kirby update, Dan role of today's to transition earlier quarterly like in would we on team. created a first Commercial newly As to member as Officer. Chief Iovance introduce joined

launch since sales. in leader updates. organizations hand Chief our for the and as expand in pleased commercial instrumental the the to a I'm field, him fit an the discuss commercial earliest we developments therapy to to our Proleukin Amtagvi cell is call Officer Dan perfect grow Commercial As

Dan Kirby

to I'm Amtagvi be I impressed Like and excited part the the been and potential details on thousands others of progress Amtagvi I the mission progress today of and critical coverage and that policies following summarized. To Fred. solid Amtagvi. other the team by patients have begin, improve into incredibly made the team. in the to tumors in melanoma Amtagvi advance you, cell launch, Thank favorable for I'm believe and to advanced broad year. I very Cancer lives with by many lives with at reimbursement the private is to lives of Network, highlight XX% has the to DRG under first Medicare guidelines, gene, or their patient-focused among XXX Iovance Fred our access additional or patients Amtagvi as scaled we ATCs with commercial therapy has for came significant Overall, to patient My objectives the Approximately Iovance are offer the network Throughout of in is in target currently success our are ATCs covered for health because Early the well. XXXX, Amtagvi medical to providers to reimbursement After day than and Iovance. growing XX patient an demand patients. of to and the meet ATC approximately the end reached care patient unprecedented XXXX. up we of on supported launching access. interest also fulfill XX X, at the greater payers more million also have than cell data Comprehensive and combined XXX. U.S. have covered Amtagvi National inclusion clinical strong access Amtagvi. NCCN of covered XX%

live drive across closest center. positioned XXX Our of XX scale accommodate XXXX launch, Amtagvi patients metrics We network ATC than to network and within in commercial of first demand. nearly within the X-hour XX a XX% treated X more states ATCs our XX% up more more patient the now for and patients current significant growth and treated is with Amtagvi, potential infused melanoma These our Amtagvi ATC and resections, ATCs, spans quarters patients. infused the completed XX as XX% all patients growing tumor growth X significant or demonstrate than XX% infused beyond. Amongst

treat New to initial ATCs patients. preparing are

or Our actively utilization new eligible increase additional and we we engaging markets. volume our ATCs be of will top similar steadily a for patients, growing volume practices. To are trends ATCs and oncologists ATCs patient drive Iovance focus adoption, XXXX. earlier including plan further more large expect will as high-volume throughout to selected referral XXXX, quality and identification follow community community practices teams are ATC high on field add These experienced steadily with community large network, higher and into throughout

leadership on with aligned their ATCs organizations preferred for referrals. key we Additionally, community patient are at

weeks review the annually for Kingdom in Union advanced therapy patients of clearance treated And patients U.S. scheduling Three testing in potential clearance the and ATCs saving and therapy. are of release United XX,XXX we dossiers journey, with be Amtagvi to time the markets, targeted for treatment in their future European X XXXX. Globally, approved to first the the the averages in decrease currently may on up treatment targeted in weeks approximately the In intact and are to product the expect and the the steady embark with by patients Financial under PD-X the preconditioning XXXX, midyear address approvals improve. all half, to more parallel previously in arrival. are to the currently regimen with manufacturing speed more additional first we has As second then half Canada making and X initiating our with time only and/or than and turnaround potential with in markets. progress regulatory conjunction for financial year. to the international beginning infusion. up in adult continues melanoma Amtagvi melanoma

provide for XX initial Amtagvi Australia. we We Germany, early launch, and access plan onboard In Switzerland to the treatment France, centers preparation year-end. U.S. also by for ex Canada, international plan U.K., in to our

XXXX. on remain submissions and half track, Switzerland regulatory first Australia second the half in of Additional including in the

include commercial across the in dedicated regimen where trial for business, Amtagvi to supporting use In use addition key treatment Amtagvi, use to organization for clinical in is clinical X of trials manufacturing lines Proleukin our and which for appropriate.

restocking. wholesalers quarter, and distributor. are including Orders fulfilled now the we Proleukin U.S. healthy and final X ordering major third provided a stock being planned all at During patterns, for fourth activated with initial

each momentum expect to across our highlight U.S. U.S. I Proleukin building pleased thousands and to demand now the will increase world. I the Bilinsky, Proleukin am and pass key year. In progress. Amtagvi the to the impact for $X-plus lines the to within business and while Igor date performance and beyond. these X expand launch manufacturing of toward are throughout growing to adoption with We call we summary, around extremely fully of the continue our opportunity Officer, to drive patients' to the sales lives billion Chief Operating sales I'm to committed peak over catalyze

Igor Bilinsky

update introductory Dan. I Thank build expansion. an and on network like you, manufacturing would comments Fred's on as well clinical commercial as our our Today, to capacity with

a internal which helps support Therapy quality ramping manufacturing, hiring ICTC, To maintenance, volume completed resumed production. entails support Our manufacturing manufacturing our clinical annual the of network schedule X,XXX we up manufacturing required that are utilization. Each growing with to and our maintenance actively short ensure flexibility both our demand continue promptly capacity Within currently our a high steadily of Iovance patients growing we manufacturer, more than operating capacity and demand successfully at a report for no capacity network, is for production at staff. brief ICTC commercial pleased Center, full control commercial in and in staff with issues. consists or contract the alignment to Throughout Amtagvi, I'm production. at staff ample is pause and facilities Cell XXXX, while capacity manufacturing month-over-month annual capacity will currently the while which annually. facility, and

positive outcome our manufacturer. scheduled following at maintenance same upcoming the the expect We contract

receiving to practices medical experience experience. Our ATCs with commercial improvements continues contributing affairs effectively to sharing from commercial over facility shipments rates clinical and time positive manufacturing to for gross and return prior the at among are cells consistently best in XX and and consistent is ATC. success The margin be manufacturing turnaround manufacturing The teams to ready Amtagvi being days time. the

XXXX. in Our team time is turnaround planning to shorten the

Our in patients clinical Philadelphia in manufacturing Europe, currently other and our trials network geographies. serves Australia

and provide in U.K. commercial of potential and We markets establishing the approvals distribution new logistics to anticipation this EU, to access now in product Canada in year. are

X,XXX vision. patients the have longer-term ICTC for expanding has also built over expect to for fulfill are X,XXX as more years. We capacity the our than today annually to few total capacity existing patients ongoing Once of shelf The annually. we ICTC within build-out we space, capacity complete a

for our expected to manufacturing capacity process and over patients Additional expansion is ICTC automation provide of along with XX,XXX campus, annually. optimization

as on cost network, by of are as as of leader our the and therapy. grow economies leveraging scale TIL unique goods cell improving focused the manufacturing through advantage we competitive in we As well efficiencies operational the our

to least cell therapy rights Jean-Marc, intellectual Officer. other more granted available own robust patents and TIL-related a U.S. through call protected by We expected patent and the at answer Q&A, Financial are for now Chief and TIL our are Amtagvi additional or exclusivity provide and the Our will currently I expertise manufacturing that property capabilities technologies international allowed to hand than questions and XXXX. I'm to portfolio. XXX during

Jean-Marc Bellemin

also I well revenue, guidance our will Igor. results position you, fourth for our as financial Thank will including margin. outlook, cash XXXX. current and Today, and I as the gross expense quarter review year highlight full our

As cash million. of our position XXXX, XX, was $XXX.X December

cash As $XXX approximately our was million. of February XX, unaudited position XXXX,

position infusion expansion $XX.X second quarter operations, the $XXX.X of transition of December quarter our will current to share for fund year XXXX. I or loss XX, planned million was per for Net of financial including different to the fourth and as per to full for was year loss of million the loss or Dan $XXX.X of a now ended into sufficient XXXX. $X.XX or per per the full XXXX cash share million compared was of XXXX $XXX current is the business, quarter Our XXXX, net lines $X.XX fourth results. the $XX.X compared half Net manufacturing million the $X.XX including Total X Amtagvi a and or for product of for Proleukin. $XX.X U.S. described. of fourth for net share within million revenue revenue million global Proleukin loss consists $X.XX Amtagvi product XXXX. Total million sales $XX.X share to for and in

for including for Proleukin. commercial associated and including directly of percentage Proleukin end decreased the $XX.X XXXX royalties initiation the the the cost for sales the drop-off and million, million product and from $XX.X were full cost for sales. certain payable sales success related our year and the million product now sales growth full and success demand assets. by product For million, which primarily manufacturing Amtagvi million. $XXX.X were sales related $X.X attributable year with was $XXX.X asset year costs cost higher includes global to in $XX.X overhead patient following of noncash noncash increase increases guidance revenue the we intangible in was strong the intangible with sales million the fourth inventory, range commercial million related as Revenue as XXXX intangible prior commercialization noncash was step-up sales. In the noncash are fourth sales royalty $XXX costs million Amtagvi and of $X.X tied year achieved million for value quarter full million primarily was intangible year, expenses in manufacturing Total the $X.X period full noncash as Cost in assets. XXXX $XX.X of of to Amtagvi $XXX revenue in to year patient In and of the XXXX, year's value a the expenses, million product payable XXXX asset $XX.X quarter the amortization primarily drop-off with million to including $XX.X market well Amtagvi. amortization was of million, well consisted X-month which U.S. including of product and sales, period, fair expenses sales sales prior U.S., that of periods primarily cash $X full launch year periods as prior associated will and full Proleukin and and fair and of revenue, the cash noncash as highlight Cost of Proleukin step-up cost our and of associated driven to over in cost in costs fourth and of for on amortization prior of quarter sales expenses, quarter-over-quarter rates, The for and over for year and and and market million, related U.S. in of for sales. I Amtagvi in rates, of total manufacturing Amtagvi $XXX Proleukin. amortization million on manufacturing

improved the Our standard $XX.X time of capacity the fourth utilization Cost million XX% margin total has product the of compared for we quarter sales was to volume increased revenue gross XXXX or as $XX target over million. and ramp-up. profitability to over The over margin on XX% our years. halfway the coming and our gross well gross surpass focus launch is throughout ongoing previous margin the reflects in quarters higher for towards

the gross expansion, now testing to efficiencies our expenses. shift further a manufacturing our will ongoing with release cost to of margin. optimize and manufacturing coordination sales ATCs expected Our strong with are and in operating higher I correspondingly

the increase our million and full This general year the full the year headcount million decrease the development $XXX.X $XX.X in of For to administrative $XXX.X general The same prior compensation to $XX.X for year year expenses growth transition and as million for quarter million to the in period stock-based the administrative of compared including decrease million $XXX million from our increase $XXX and compared were to primarily Research million to in commercial selling fourth manufacturing. XXXX of XXXX, an to guidance and full million. million an over the increase legal total year development decrease was the to Amtagvi partially full clinical were expenses a $XXX in the and trial cash full were prior of the expenses expenses $XX.X for expenses Research year in $XX.X development periods period $XX.X year to for XXXX, $XX.X burn, decrease for compared fourth expenses within period. million million offset quarter period. of the of the year Selling, the XXXX. year our in commercial-related quarter year prior was headcount year $XX.X research and attributable $XXX.X and onetime range stock-based million for costs. Selling, related was and attributable full well expenses excluding quarter fourth prior fourth XXXX, support of and a compared The million million and as including for increase to the costs, compared XXXX. was increase and XXXX, by for were general administrative costs. of related and compensation full XXXX, clinical costs, and primarily to XXXX overall $XX.X

we prior reiterate ahead, of the Looking continue million guidance our range the revenue year full to to product for million within XXXX. $XXX total $XXX

anticipate our grow time, to as decrease burn than our we XXXX be addition, $XXX improves. facility for the expect in million, expansion. ICTC continue burn including we revenue margin In gross cash as cash year and full investment less to Over we to

additional this plan to further leveraging to opportunities spending keep also year. We optimize

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

Friedrich Graf Finckenstein

Jean-Marc. you, Thank

well top U.S. about frontline I diagnosed cancers to clinical for pipeline. Expanding be all key at summarize more continue a programs is of the next-generation the commercial updates the cell will our as exciting excited XX% for therapy in into advanced solid Today, potential than tumors, which priority in of melanoma Iovance. TIL Amtagvi as opportunity represent We our

regular and frontline approvals indication remains melanoma. Strong in initial in combination Amtagvi well and TILVANCE-XXX, trial, among III enthusiasm full track participating our to accelerated planned Phase momentum sites. in support on melanoma enrollment registrational global of anti-PD-X approval continue with in high advanced as in post Amtagvi clinical as of pembrolizumab with Our

for in IOV-COM-XXX checkpoint another a IOV-COM-XXX best-in-class is supported melanoma Cohort results to inhibitors. advanced XB investigate with patients positive lifileucel plus explore alternative by and relatlimab. As melanoma U.S. reminder, combination potential will TILVANCE-XXX in nivolumab immune To pembrolizumab patients, from XA for frontline physicians lifileucel with naive in advanced and Cohort in

provides monotherapy anti-PD-X care Single-agent lifileucel advanced in medical investigating cancer is registrational the of Phase II IOV-LUN-XXX need progressed trial after current non-small clinical among single-arm standard who address program therapy. chemotherapy, in of unmet duration registrational the second rate limited responses. this with setting cell Our and patients to lung

in high We lifileucel at with sites non-small expect countries XXXX. to cancer in lung accelerated additional approval anticipated to clinical IOV-LUN-XXX anti-PD-X second the support in half Enrollment a XXXX. of continues with of share the data demand an multiple potential decision in regulatory post cell U.S. from in

We in following regimen a treatment non-small non-small cell setting. non-small is lung wild-type to with represent pembrolizumab In lung EGFR pembrolizumab of majority earlier of patients medical cancer new pursue who cell patients with in of establish this an cancer. continue plus care our settings frontline strategy frontline lifileucel advanced also cell unmet to lung cancer, the chemo for need standard

We trial investigate a will frontline confirmatory XD this cell cancer. and in the IOV-COM-XXX regimen registrational non-small in inform to trial advanced design clinical lung Cohort in

the strong Cohort who in previously to is combination goal pembrolizumab augment with therapy. checkpoint inhibitor further with immune treated XA in lifileucel not with efficacy seen patients Our were in

anti-PD-X trial are an setting. opportunity in post along clinical a TIL pipeline, significant cell additional new the endometrial first our Moving in advanced excited about cancer, therapy for we

of no approved therapies have repair patients of with IOV-END-XXX an patients unmet chemotherapy trial MMR to progress. created year. look or standard data of frontline frontline lifileucel of half with status. Our END-XXX endometrial are cancer, after checkpoint We the therapy in is in currently second of for clinical inhibitors regardless initial care immune in who cancer and Recent investigating sharing approvals this forward anti-PD-X chemotherapy There mismatch need. from for endometrial combination

also Iovance in therapy, optimize cell TIL of briefly regimens. at forefront leader next-generation is area. X to this main I'll treatment the TIL As and programs our approaches the TIL in summarize

Phase cancer. with cell melanoma trial IOV-XXXX, in are TIL our on of stage clinical may with enrolling patients we previously therapy a an cell IOV-XXXX treated inactivated pace advanced investigated to frequent a franchise, the of use non-small Phase Proleukin. II TIL IOV-XXXX support and X of cohorts IL-X or modified is cell therapy efficacy our lung I/II across trial. analog safety IOV-GMX-XXX Proleukin recently Phase less Our result better at dosing the Multiple second-generation next-generation compared successful a for increasing II initiated regimen. profile PD-X Building centers treatment in clinical

partners with make additional these about plan to with Cancer therapy. you Q&A improved trials Lastly, low cancer cell updates IND to and the Thank doses tumor settings market tumor TIL without this cell additional to I'm efficacy possible. I deliver the use and to IOV-XXXX, talented year I enhance of to IOV-XXXX of tethered look multidisciplinary to IL-X work and of submit Operator? year to prior IL-XX turn questions safety. begin call and programs forward generation will Institute the who the into TIL trial IOV-XXXX wide inducible provides could to to facilitate the solid significant the FDA genetically this therapy rationale common opportunity. question-and-answer TIL session. we IL-XX an beyond types. National TIL showed happy therapeutic sharing the expansion we engineered for for over operator to address additional the continue The a therapy clinical modifications cell at research the in a a additional in during this optimizing while team with our range patients cancers session. current pipeline to as and now efficacy

Operator

Andrea Goldman from comes Newkirk question first Sachs. Our with Instructions] [Operator

Andrea Newkirk

number quarter. infused calls patients the prior in update on of thus far provided you've on Fred, an the

confidence then when to understand still willing where today? which into was help you share set be for the only you'd the or as full X the us if remind wondering is us 'XX, just that year quarter you launch Just you're intact. what gives And stand of range

Frederick Vogt

only some and In release this useful it's We long at Andrea. investors. time that for you than the that at we're and part as have answer more to acceleration providing as the heard including the was gives second to the the And commentary, the now, ATCs And metric we're to overinterpretation. prone right of which release good XX in if through. actually in a second our look your going question, on XX to of expecting half second is different the press of provide around, not we know, patients, you and growth infusions we're go you upside be metrics of a within expecting, the Dan's quarter call, of We're XXXX the how infused that the idea sure ATCs. sure, now. we press Yes, not that right very potential here XX% some

So and we happening the those in accelerate network we can still of bit, for the have see see potential the our now. a numbers confidence that because type for growth across this product quite that curve ATC right ATCs. We in

Operator

Lawson question comes Barclays. Our next with from Peter

Peter Lawson

kind could of for distributors? stock kind this we XXXX demand? is of revenues future that think IL-X Or a revenues, forward? had nice signal As about we component of should the about going What from in IL-X a that think they the be? a how spike And quarter. we Should view kind TIL of as sales that

Frederick Vogt

Yes.

been what the seeing to sales, seeing saying as uptake continue So you're for for And some being we've now. talk the all in we [ continue to time SDs think you're is I believe IL-X and like States. leading Amtagvi United indicator quite ] a about by there the now revenue

million out a think We million out, right $XXX as restocking X That's it have sold significant and that $XX restocked And block see I more. be of and will to now. there. It a fantastic performing well or to we could you'll very guidance a $XXX think business. why it's it. to million the of in $XXX pointed Dan It's million portion we'll represent XXXX, we acquired As third. again, them we be

happy very that we're with number. So

Operator

Burnett Our with Stifel. next Ben question comes from

Benjamin Burnett

new this a guess are landscape physicians later and entrant I is the year? just potential evolving the for sort of for a us about what saying question

Frederick Vogt

what written I very this about of basically differentiation the this. entrant currently similar a colleagues of known think potential sure T-VEC. to lately, notes We're being marketed and a as been have lot not your product as about between that. there's the many really view is discussion We

We being view to their earlier. as on the Their also of patients X prior had adjuvant we're They comparable clinical is data patient lines, more of more launched. lot much product information a have XX% with XX% have We metastatic the that to much, real-world much in not or lines. prior ours. about looking X how a patients population our X/X at And of in X PD-X melanoma. with study. patients of only population

product, to with outside we're looking don't of can. launch. being this there grow launching our any other kind our we premier market, on impact indications soon we So as the and what out see We're and really we significant as the U.S. get is think

Operator

Our comes next Kusy from with Colleen Baird. question

Colleen Hanley

not going did understand slowdown any back forward, there in you quarter? half in the intra-quarter And infusions seasonality since see was speak, XQ, a I you the did can of giving you're but XQ? updates you in in provide

Frederick Vogt

Colleen, no, seasonality. we don't see any

a did mentioned, period we Igor As maintenance manufacturing there. have

So those of we cell have in therapy. kind things

the holiday those that in If for what little terms and launch happen. YESCARTA seasonality. you But like nothing and curves ABECMA, so. you'll valleys dips at That's CARVYKTI, of in asking. peaks things look a and as see there's you're

Operator

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

Unknown Analyst

potential the a on for ] And guidance? how price included about is having on that U.S. think [ should Tyler. increase also, guidance, in guidance, XXXX ex is the guidance? Nick currently we Thinking This impact expansion global potential about

Frederick Vogt

now, been Amtagvi. from the both Proleukin that price guidance doesn't The into for right increase factored ex include And April in contribution that's U.S. any guidance coming has and Yes.

Operator

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

Yanan Zhu

does be that same the either that infusions over how over be expectation? were was XQ quarter, different was growth in will growth how compare I think your the XX for the And performed does do or quarter-over-quarter prior you infusions, which XQ? with wondering XQ? many And

Frederick Vogt

with fourth infusions. and Yes, kind XX for that infusions occur that Yanan, of other thing single is sales, we're about generate reporting There's revenue what XX quarter. about it's revenue infusions the still for It's of INDs patient that Proleukin example. revenue

It's the go that down think to need is we growth I see. we seeing growth as the We're quite strong. quarter-over-quarter going go. and up to

they where were CAR-T they flat, products, look there's at XX%, you there's there said, the XX%. grew their where where quarters like Just they was with if grew I quarters back growth, quarters

to we we we the to and is right in as opportunity the drive that tremendous ATCs into as have well intention Our have growth, community. that get do now

Operator

with next question Goonewardene Truist. Asthika from Our comes

Asthika Goonewardene

ask, are new XX have steady have treated of provided, with Fred, what provided, already their ATCs I'm that than state? data wondering, more end-of-quarter online, that that you the that align patients? proportion let of ATCs XX% me XX data reached the the that the you does

Frederick Vogt

the on very majority probably number. So tell of ask far it's point. a of exactly, I or what tremendous it's little a seen know less think that to the can't state those ATCs reach you I'll have to on XX potential upside Dan Maybe we've steady I XX% so We upside. at vast those this bit low comment ATCs. but

Dan Kirby

our have have are and only into community for you you in centers, referrals I think ones look centers. ones don't the towards excellence again, ones Sure, referrals driving that not of developed really if strategy the are with Fred. really that plus, infusion at they're things doing of leading those to but for with the one look inching think activities that Amtagvi, it to the They're we also it. in And increase the XX-plus centers expertise our because that other saturated ATCs, Those those. are are at number the is, I XX the other our way with that

Operator

Benjamin next with from JMP. Our comes question Reni Citizens

Reni Benjamin

Frederick. on me for Congratulations just pipeline quarter. the Maybe on one the for

talk bit little data, set before another non-small of I be with worth and Do endometrial? expectations to second to and patients accelerated or cell have we data? do year. this this is patients in becomes endometrial? more approval out many color in for for registrational data of need a both And We non-small great. the filing we coming half you guess about registrational both cell this Or start cohort Any the Can set? data even enroll would set? need ultimately that How the

Friedrich Graf Finckenstein

Yes.

would There's going About think is because the registrational X additional reporting which data that from on depend at that with venue we out that can't this not cohorts update of in I is to we with which with cohorts. said obviously and enrollment regards an be that So I will timing, will time are be be the probably really the on appropriate priority to will Obviously Cohorts X, and be the end on interest, what anything we data time timing or really comment point. plan, expecting and will of disclosure is we're an not timing this This to that. the in we're are that relevant. registrational going the start script, the decision by LUN-XXX, thanks my a we question. registrational Where our cut of for XXXX. our to

to we're and the We're your We answers that still. in with number an data number going commit gives that initial similarly, trial. find seeing I can't on around you meaningful a that set it's We at currently. I track be hope to enough seeing specific share are endometrial, to momentum, enrolling year here, signals really important this we an this Around that. question. good least are patient but early this idea a

Operator

Mizuho. from Our Salim Syed next with comes question

Unknown Analyst

Bennett the is and the [ This ] for Congratulations all quarter on Salim. progress.

post the registrational trial in Phase II cell on cancer. also anti-PD-X So non-small lung

So could we the if XX%, just here a the anti-VEGFRX what little bit I'm comparator if rate best [indiscernible] response believe [indiscernible]? around or not is I the that's you about can you remind talk [indiscernible] us mean here. but sure

Frederick Vogt

can Yes, of can and I maybe rest start the that. Friedrich get

REVEL very the ramucirumab is but that XXs, a First includes with not response we much has study, low FDA available we look which for longer at against short with at monotherapy. rates would What have can durability. plus there, will randomized look the looking therapy, -- durability. of all, submission, running those we patients, at run is you're TIL told FDA us can And docetaxel in we and for here. the that And care trial run We're BLA single-arm docetaxel. docetaxel

we told on Fredrik, come quite approval the if like And of rates about to told before durability terms they've bit us this. product been thinking today, we're So add welcome fine in you're in can the with we that. seeing, to we've a FDA be should -- what on we us and has getting with mid-XXs like this based if you're response you in online, showed

Friedrich Graf Finckenstein

add the standard of the here No, that's really here limitation for is the to care. durability one that it's The thing exactly right. is

X docetaxel response ramu, XX% has never again, response it's For PFS plus been mentioned, although, months and Fred shared. about about data is duration as of rate.

indicating therapy. I with the So that and think limitations the is planning lifileucel on challenges that addressing we are

Just communication in previously XX% around data as had which of saw is responders that the it, we population than very response then DOR confirm meaningful. a shared from LUN-XXX the XX%. of indicated mid-XX%, reminder, a the a in follow-up we had this rate And more months, X that in

Operator

UBS. Our Dai next question comes from David with

Xiaochuan Dai

impact mentioned any you you Fred, kind spillover wondering any break. if holiday seasonality you the know of see or holidays resections? forms on start I'm I didn't But just see for that from

Frederick Vogt

on repeat Could you that, on David, resections? resection, seasonality

Xiaochuan Dai

any No, there's or holidays no. of if any that Yes, on wondering of makes spillover kind start from tumor no, if of forms any kind kind resections, impact sense?

Frederick Vogt

if for patients there of they you. following course, that's not because ATCs just without there. X interruption to the We or really Maybe could generally. are what for be here operations generally asking the of their holidays more of any any I'm holidays, or Christmas running try see you're terms Yes, the cancer through answer I didn't patients. can in X any slowdown Yes, for just

Dan Kirby

see pairing we're on we to to we something seeing look data. we're at. seasonality. first seasonality, there just didn't in trials. year, it just clinical top as Fred, is going it, the the go go from that, forward David, patterns helps Right of But think so looking we're those at you, Hopefully, we're now commercially, trends as is in I not for actually, that understanding, if that we notice but our finishing And my and

Operator

with Tsai Andrew from comes question Jefferies. next Our

Lin Tsai

forward XXXX. Look to updates. the Appreciate

is, the is nor XXXX at this is say in uptake, you seeing not factor the sites, would nor exactly to you for patient what an guided? at of one supply gating sales quick what in bottleneck chain it's a terms launch like demand acceleration beds even If juncture? So the

Frederick Vogt

are that So get more that right feet I working And up way got think starting are above are very, that now got we've now. ATCs lot We've performing and under all, get them up. very running. their well some their the a have ATCs to

I its has each there's think own each individual little in a ATC, ATC it or whatever -- be. might bottlenecks difference

Some have of issues. staffing them

and portion can think all of we pretty ahead. have Some easily resolvable, lot pretty a been we we're out soon. able good to are helping go really we've Dan, fly things financial with. clearance there can our and ATCs get now, that these challenges more of them that But show a right

Dan Kirby

but what Sure. they regarding sure I do really add there's can have go bottleneck, of it And Fred thing think to they Andrew, on to not top process a again. first the in We're make pill said They a one the market. through. operationally

there. a there's So curve learning

to see, you have XX hit That grow. XX% or As continues said we more. number

leadership see level working pull also referrals are they getting the centers and patients. So there. the use clinic we're then where lever to patients they more the understand those not only most to level, that make but with once to the the at wave drive that hit And it, community, that's community sure to and really with is how where the in the product the

Operator

it to I showing time. now further closing Interim no I'm Fred remarks. Vogt, for CEO, like and questions to at would back this President turn

Frederick Vogt

Thank Fourth Full the Results you Biotherapeutics Corporate Year Conference and Quarter again joining Financial XXXX Iovance for and Update Call.

of the on close launch, our our commercial updates providing we first calendar and portfolio. therapy TIL we forward As first to clinical commercial year growing cell look future

generations delivering as and We I'm our is with maintain ATCs poised to Iovance continue patients confident cancer. feedback advanced in future therapies for of current hear that cell we with be to developing leadership setting. finding the from frequent hope global about benefiting in Amtagvi innovating, patients motivated melanoma TIL and and commercial

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

Operator

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

may now disconnect. You

Iovance Biotherapeutics (IOVA) 27 Feb 252024 Q4 Earnings call transcript