GMDA - Earnings call 3 2023

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Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Gamida Cell's Conference Call for Third Quarter 2023 Financial Results. My name is Chris, and I'll be the operator for today's call. Please be advised that this call is being recorded at the Gamida Cell's request.

I would now like to introduce your host for today's conference, Mike Kuczkowski of Gamida Cell Corporate Communications. ahead. go please Mike,

Mike Kuczkowski

quarter and results we everyone. at on will our which release on the and Chris, we available this call a is providing issued the to a during www.gamidacell.com. review press third for results which provide our financial website XXXX. good you, Earlier Welcome morning, financial morning, summarizing today's company of and Thank our an update, update business

Chief are with Ronit Michele Executive Financial on and and call and Jenkins, Here Chief and Simantov, Officer; Coelho, Officer; Terry Officer Officer; today Chief Commercial Abbey Officer me Medical Operating Chief Korfin, Scientific Officer. our President our Chief Chief

remind the Omisirge, Omidubicel we curative launch and future and cell of this Omisirge that of expectations during market may potentially therapeutic generate potential GDA-XXX, including potential ] capture about commercial OLV Before therapy to regarding call, respect share with life-saving candidate, our I expectations to plans, begin, or revenue. to everyone company the make want [ we forward-looking and statements the

support Cell to or and Israel facilities ability may impact the keep Israel for launch of financial commercial Gamida operations. strategic Gamida to its partnerships Gamida future Cell's its of developments plans workforce state open, runway, Omisirge, that Gamida Cell's Cell's adversely the

those effective factors, considerations in of as our and may make with endeavor business the are well safe those developments Risk related the may that from from actual as due scientific, for to recent a and we SEC other in as what report our important that and in commercializing Form materially quarterly most around time use human and section on product XX-Q filings number and of therapeutics, the differ developing technical building Factors product time. candidate of including described and those of candidates Our to to results we the and project a product today regulatory process clinical, inherent

views whether only update and events, we our future, you may new represent statements that a by as except as information law. future today, applicable as of caution forward-looking These the not we result in required of them or

me to President Jenkins. our call Abbey turn let Now and the over CEO,

Abigail Jenkins

today. by brief be you, update. begin Omisirge ensure first living joining as commitment to team didn't acknowledging We've remiss go us dedication I made and corporate zone. to courage have deliver everyone in and providing members this patients the call shown quarter, a I'll a want we in Israeli strong to reliably patients need by if our I but into to war moment, in on Thank operations continue would resilience incredible I progress and working Mike, while start of this which who a they detail and

their towards Omisirge to continue serve represent patients circumstances. For challenging cell of an last under in malignancies here, these hematologic with transplant, are allogeneic to we to our or proud may best and hope stem need be able patients

Our remains employee are able and key relieved everyone be is say to we to safe. safety concern, a

in the flight As airlines cells of been Israel. could to delivering many centers U.S. and back getting you Israel might suspended Omisirge process transplant have in imagine, when impacted into the service

strength in members team demonstrate their To witness. been environment when impacted, maintain resilience has not first in were inspiring put working dedicated did unfolded. challenging lives and diligently operations our team to Our to see a of hesitate own patients adapting to as employees such real-time and events

corporate to gears and Shifting moving on update. our

for enter access key has launch expectations launch, lean we the across market defined and our metrics for Our patients. onboarding exceed transplant to continued X

goal commercial our for top of more lives payers to with the goal XX% Omisirge year projected top XX XX U.S. This than commercial U.S. of of centers, morning, includes have covering all the As payers. centers XX transplant transplant confirmed full coverage coverage has XX%. with this we exceeding onboarded year. of of the XX confirmed exceeding of our end

and Medicare confirmed centers have Omisirge for majority Omisirge. reimbursement Medicare coverage for with vast coverage patients for in has This and the place of now also means Medicaid the services.

marks to a Gamida transitioned moment commercial revenue our Cell with The third stage quarter truly the first company reported.

proud Omisirge therapy We a cell potentially need are in life-saving for so donor of source. to a transplant provide those

for We of in from year a XXXX. are the quarter, Omisirge X delivery of estimating of units to of third are revenue reporting X revenue total delivery X from the the the units and Omisirge full

its with on the received transplant very as and consistent Assist Cell on transplant the to value ramps importantly, first volume and a the transplanters on are on gene fill process and aligned is need. ability from pharmaceutical strong patient and see resource the basis a onboarded unmet onboarding an Omisirge's potential. launches Phase number our Omisirge III lean most true tool based centers option and trial randomized on of [indiscernible] in and feedback Gamida Omisirge transplant cell expectations and with the of The other and and model We've launch approved global only space. centers

enter due need the as market and we that additional funding. pursue there XXXX, maintain resource continue our The early to our market Omisirge research can in end insights, to is Omisirge we an lean phase confirmed constraints interested prioritizing to with in prepare to will we center has our expand patients will forward centers resources launch As XXXX be unmet for of Omisirge. virtually are that to launch of an to based Considering moving position, we malignancies. invest making cash Rapid thoughtfully our transplant hematologic access on option the Omisirge onboarding patient fulfill. all efforts transplant has proven need

Assuming to more coverage we in XX to and second, support by with To expect at of half access commercialization onboarded a year, strategy strategic of end transaction have least market than cash the our reimbursement. transplant to the our we XXXX, X-pronged by this announced pursuing centers launching fully extend transplant the in of centers focus Omisirge first to top -- and patient including remain involves runway, U.S. on resourced access ability U.S. fully And a committed earlier corporate XX ensuring centers which our to Omisirge. the reiterate, partnership or transplant onboarding expanding

business In terms a are development of partner strategic identify our activities, to efforts ongoing. our

We Moelis have investment which potential independent from received Company the process and has proposals. by & bank, partners during leading in the and global been has multiple considerable interest written supported resulted oral

address development However, for we be not to we to continue business have will identified adequately in have us will to It capital partnership at present, a critical that ensure X-pronged and the strategic XXXX. plan strategy. sufficient needs process this execute our

to increase capital. authorized and continue potential this Gamida in achieved an in with including transaction X to General one be should voted Annual the a in share was us our Meeting finance October. recent enable of will provide shareholders approve available meeting, relating majority to operations us. step our business, At at a the the key process proposals to Cell's A Shareholders to flexibility of held company's This

lean expand So in centers Omisirge maintain number patients is to summary, the approach of into our we launch ahead onboarded proceeding of our transplant launch to our lean and expectations, expect and XXXX. receiving

for company, stage being to total official X commercial a We transition our into a report are XXXX. Omisirge X deliveries to of the expecting deliver units reporting to first revenue and year full proud

to a to now on support call and I launch. to Michele the to you. funding will seeking update Omisirge, access to patient Michele, Omisirge. the necessary more the enable expanded are for over turn in-depth over partnership commercialization fully strategic We a Omisirge of resource

Michele Korfin

Thank and you, morning, everyone. Abbey, good

to how is have As a efforts patients access process Abbey of as launch lean donor advance Cell will in transplant. allogeneic patient sharing to ensure center need the in Gamida need the mentioned, transplant to organization progressing resources across of an Omisirge stem on continues a be bit a I launch for cell the updates and prioritize and as for of context to regarding well Omisirge delivering few execute source a of a use therapy. the

centers, strong not including interest from transplant III trial grow that to in were since The update. last the Phase centers has of our continued part Omisirge

this centers. already onboarding target we of our morning, having considering is with XX our onboarded full we're to the pleased how with we exceeding centers, XXXX have exceeded and As resources for which XX proceeding, Overall, limited transplant year expectations range XX launched. of

commercialization half to anticipate With onboarding, last transplant our onboard additional could we expanded to securing robust XX of subject managers to ongoing since than U.S. more have the by continuing onboard least this support in the of place resources our team expanded centers our provided anticipate To we call. XXXX, and top Omisirge. we a transplant pace. in the the at financial the including we XXXX, transplant obtained end We In necessary of at account centers XX support of centers capital, team

key stem allogeneic to XX about transplant Transplant this search. is annual of center targeted to top the is the an cell on XX% a with As centers enable a step transplants patients reminder, onboarding a of basis. performing the on market access

closely personnel be quickly determined participate works has policies team approach, flexible factors be availability onboarding and how each onboarding can currently evaluation candidates of status center the with Gamida centric administrative ability as clinical training source. team and to required with of the a Omisirge begin to Our donor using procedures timing and our on transplant The the staff may onboarding good individual onboarded like is the include Omisirge. transplant a is for patients in to transplant center the under by the and of who needs

Once quickly to is are begin have who cells patient able received as Omisirge source identified ready the to a very manufacturing. We search. selected are by and Cell, have patient's been a onboard Gamida donor drama by centers allogeneic the transplanter we already

within from the and an Omisirge manufacturing. experienced in we reliably to have place, days team start XX are We deliver of ready

time, expected the transplant transplant from to In Omisirge to to and identified as having this terms as a on at number deliveries of tracking onboarded we a the takes transplant anticipated candidate we for the for we patient go the time centers of are being number place. taking date, typically of it based

for take to initial Omisirge to evaluation Published receiving number preferred is is are to getting familiar first center is in consistent to for on The transplant and centers that shown XX and of clinical so exceeding centers, to have XX position Omisirge. transplant depending months critical therefore, approach of very with accelerating months, we our X patients may to the resources a profile. X considered This focus onboarding. of transplant other is, patient why range target a transplant launch diagnosis center the the patient's us increase process personnel. sources, and a in donor it By data our on

Cell an donor transplant in as indicates now are patient's the seeing Gamida to are number more onboarded, enrolled patients centers Assist. in Enrolling of Omisirge a Assist use source. As Cell we patient a increasing intends transplanter Gamida

additional in source could we units of Omisirge as patients. delivering full progress of a our of donor for of share third result to for a year I is the that the total a manufacturing XXXX. X a milestone X we and X reached delivering Omisirge, As Omisirge units underway project quarter, for of

fully transplant variability making capture up expectations, Cell commercialization. Gamida are the our XX% the gone truly Given support secure for Kerko the line continue its war. Israel-Hamas numbers excited beyond efforts patient the able [ possibility for share that and of Omisirge with peak have lines during funding I are operations resource in our to ], necessary also we Omisirge a center facility will time and ensure preparing are Israel, continues and above team manufacturing to at of provided pace we has that heroic the to our transplant, at about to note in onboarding these to market to and

We With it the could most facility of continuity Omisirge concerns our additional of and manufacturing for and Assist, we'll overcome quickly to our logistical needed. and ensuring the situation enrolled and X remain adjust one Omisirge was the were plans as thanks of in business we the employees. Cell challenges transport With said, patients patients. out and our that operational, monitor we Gamida as our adapt to able resilience to to ongoing launch that and facilities dedication continue evolves,

have have all access incredibly to ensure are of launch they Omisirge. global patients to a proud in of our passionately employees need within lean as effort worked team of We the

is member patients Omisirge role to to Every need. in bringing honored play team in a

like Now I'd the Ronit to call Officer. Chief Medical and Chief to Simantov, turn over Scientific our Ronit?

Ronit Simantov

cell be I'll Omisirge you, from Today, Omisirge candidate our centers transplant NK on some therapy data and early recent on Thank Michele, GDA-XXX. morning, feedback and good everyone. and sharing

know have with physicians interest Michele transplant My I engaged at we the growing institutions. an centers for see teams multiple Omisirge centers. our country, transplant option identified and eager team from stated in continue number Omisirge. are as that in for engaged we are these value Omisirge hear their see and the we onboarded As conversations at staff transplant feedback clear are their to reinforces for the need Omisirge. with additional donor discussions note, The across and our from patients a of a transplant make source patients of in confidence candidates earlier, Of available to and centers we

So whom Omisirge Cell have Gamida enrolled go were would who is option and the some Assist only far, in that the patients for transplanted. seeing on otherwise

patients rapid to are patients in including and NAM considering were new populations The advance the Omisirge. of [ and in surges that and application action. Taplow Omisirge mechanism Immunotherapy makeup data who a the other potential SITC cells, for engraftment ]. or cellular a Cancer the of myeloid potential technology dendritic recently our We at reconstitution where providing meeting with leads transplanters immune unique And enriched options, showed observed some cellular data composition, Society that on further transplanted over the for mechanism of annual our understanding presented

from how Omisirge donor-sourced emphasizes This is other differentiated options.

can chat Director Gary you with transplant a Dr. Omisirge, virtual will and at transplantation holding of experience and Professor to via that Monday, Hematology will that take I'm Schiller, Reagan share recorded. fireside p.m. UCLA opportunity Ronald a be hear webcast Time cell be directly the So about hematological will stem X we with of to physician have from also event Medical pleased his X:XX Center. Oncology Eastern and December malignancies place at This on

onboarded one where Omidubicel, an can transplant patients the III Schiller of Omisirge. is access in Health Dr. centers Phase UCLA XX was of investigator the study and

talk to killer time candidate, transplant to In to like diagnosis news natural sharing Dr. the to experience therapy the patient's around about about journey take cell his decision-making share with will addition donor source Schiller the from our I'd Omisirge, recent GDA-XXX. and some now selection.

XX of to therapy, from patients. safety with our non-Hodgkin with in cells or a had Enrolled treated therapy study the of determine preliminary in showed enrolled multicenter patients doses and kilogram heavily I Phase toxicities CAR-T patients refractory lymphoma We evaluate tolerated first in preliminary with and prior cohorts, cell from cell and median in the recently patients I data designed dose. CDXX Phase X X pretreated hematopoietic to of million in of The relapsed prior positive cryopreserved were of XXX maximum including study per reported X ongoing GDA-XXX, data dose-limiting GDA-XXX. no lymphoma stem up transplant lines patients

in study patients full data cohort showed of the patients with investigator-initiated These response of shrinkage target the on The patients to from on in in report marked of with the of I complete fresh and study lesions consistent reported which using X lymphoma. the X GDA-XXX, with of in X data responding. disease. formulation track Phase response, Lugano and XX partial complete appeared patients, responses be are the saw results dependent first evaluation final We X with efficacy the current criteria with and dose XXXX. fourth Activity and stable with is demonstrated X we previously Cohort X non-Hodgkin X quarter to enrolling, are of

Chief availability Financial institutions to further will We're transplant scientific work pleased and about turn body over NAM to of add our Terry innovative the Officer. Omisirge evidence to centers continue academic of with Coelho, the to I to technology. call mechanism and our potential the Terry? and now to of the

Mary Coelho

share Thank revenue that first for good Gamida I'm in Cell its history. you, and morning, time pleased the reporting Ronit, everyone. to is

XXXX, company, royalty and our cost of some those beginning to sales, incorporated With X The patients. product were XXXX, scale through insurance in we quarter third $XXX,XXX, Cost the volumes and given margins into point production net and third quarter resulting we those the of the number including manufacturing was in deductions the the will improve reporting quality particularly of financial I gross have reporting the expect a transition with third September of quarter are changes allowances $XXX,XXX Omisirge. capacity. ended transplant to quarter. and delivery XX, as for to revenue of the therefore time, of a addition direct to out changes revenue-generating expenses key and in cost the of the from confirmed as units net of Over the financial status coverage measurably to sales we results. In of walk gross been low

July research or expenses Beginning and of X, or and company's XXXX, administrative expenses been reporting has reflect either transition general operating selling, operating stage, reported as modified to the commercial to being all SG&A expenses expenses. development with

and For XXXX X were SG&A XXXX, costs and combined and the administrative previously first expenses. commercial of reported quarters into general

now in periods. being XXXX no quarter research beginning reported development in reclassification the and in previously with expenses reported third prior are of certain of Additionally, SG&A

in Research aforementioned quality with of XXXX. of The expenses were the reduced and due clinical development along an million was the of in relating million supply $X.X to Phase clinical same XXXX Omidubicel in reporting the and the third $X.X third were the $X.X resulted the compared Selling, XXXX. $X.X and expenses million of million aforementioned third of medical trial. to increase indirect certain general quarter affairs III compared decrease quarter to The quarter. contributed million quarter in inclusion the of quarter reporting million financial primarily $XX.X spend administrative the $X.X transition, increase reporting to expenses and in the million assurance in transition, SG&A chain XXXX, to in $X.X which

costs, labor costs marketing $X.X staffed year overhead facility demand period, capacity manufacturing income facility to period were cost in these costs the expenses compared commercial to XXXX produce same third the Additionally, in sold million in $XXX,XXX in in anticipated To launch prior the million associated $X.X Selling the incurred coming compared costs third the of the the of course quarter. quarter year. over to capacity goods manufacturing expenses upon activities. the in further our and and but expenses due by the were and given that million quarter excess recorded of SG&A of with excess is Financial income reflect not expand of to XXXX. net $XX.X absorbed our of the increased in

XXXX. The related income valuation valuation warrants million in company's million was primarily convertible and of of related to change million liability, to of the notes due income $XX.X secured issued in the the income December financial to $XX $X.X senior of

$X.X the of change net Our was quarter driven million just financial the third of in third by net XXXX, primarily $XX.X in quarter loss $XX.X the loss a compared as million income in to million discussed.

public in issuance XXXX and principal note $X.X of As underwritten total in cash as market the Cell X of ordinary million the warrants XXXX facility. in $XX.X company's and Offset proceeds $XX.X convertible April The of to equivalents is activities, used had million p.m. financing of decrease activities. cash via senior million September of million of primarily XXXX, cash offering or of XX, cash payments ordinary million Gamida by from XXXX. and million ] in the December operating and compared proceeds XX, at company's the million net to in net the of $X.X comprised from shares $XX.X net proceeds of [ net $XX.X from shares the $XX.X issuance due in $XX.X from million

activities average of well Gamida in quarter proceeds operating third The to the net its of second as beyond share. an and of raised company ongoing Cell's operational $XX.X facility additional current its excluding plans Omisirge any quarter million per the commercialization the from activities support cash of $X.XX on ATM the funds including XXXX, cash price activities into in based company be expects The launch the current its close undertaken. quarter may that raised financing at equivalents, the and third as to initial subsequent

of September of strategic our convertible with restructuring year, The million. convertible at secured XX, XXXX, Omisirge, Israel its XXXX, senior resources million December reduced and single an including XXXX. $XX.X location. note third now from on Earlier note the company company $X.X for of of in principal the embarked in that had by completed vast principal to the of process, XXXX million million quarter of As the process balance as amount to on the to majority have holds the XXXX prioritize launch a end $XX also a we of a consolidating aggregate mostly we $XX operations XX, the

our General call this the an in approve shares to Cell's As of authorized us recent provide shares. Gamida back I'll We to voted to mentioned for over authorized Meeting remarks. XXX operations. capital Abbey Annual Abbey With that, million believe at flexibility earlier, Abbey? the shareholders increase necessary share concluding ordinary with our finance to in will turn some increased Shareholders increase

Abigail Jenkins

Terry. you, Thank

summarize discussion us the key turn of operator to the for the the to bring the want questions, points I call I today. Before to call over around back beginning from and our

key progress goals We continue launch and of exceeded commercial Omisirge, both make strong access. market the to for having across of launch our metrics onboarding the on of center transplant

for for deliveries we in of have on transplant lean which XXXX, the unit to Omisirge and revenue based line X our the launch of X patients. in deliveries Omisirge initial with year launch for is assumptions our and third process full Additionally, model X the reported project quarter

Operations than war. the to onboard continue the Israel-Hamas the least our XX top during as launch With additional XX end securing our total by the place and Omisirge of adapting more XXXX, transplant we capital, in access could U.S. the necessary anticipate and of transplant patient of centers continues team ensure half Israel of a including we at expanded team is ongoing processes in centers to in

business strategic not development, will identified in and needs a to our plans partnership we have that business continue the XXXX. address development of adequately process terms In

for GDA-XXX readout are full XXXX. track trial share preliminary early the I promising and in from data shared to Phase We the data on clinical

our virtually resources our prioritizing continuing are manage towards all of carefully to Omisirge. launch the We expenses and of

is increase believe in potential to to cell increasing unmet We access our ensure have of are promising and address a long-term success access are Omisirge and need demand stem needs launch critical NAM see working to cell our transplantation. to for We all that Omisirge's therapy. sign in early thrilled modified patients

call let's Now Chris? open the questions. for

Operator

now gentlemen, session. question-and-answer is and from Blum Ladies will Needham Co. begin Gil first & of you. the question Thank we [Operator Instructions] Our

Gil Blum

just patient relatively color right us point. anything types at this some give the number patients or given could the So now, that on know of in the small queue you individual you

Ronit Simantov

happy and I'm thanks, weigh Ronit. for to in question. is Gil, the This

So yes, we on we're them so there transplant the Assist, of that are what patients. from know transplant hearing and enrolled like. we these some we who different patients the are with center Gamida directly depending physicians patients facts kinds when about know Cell what about also information potential are And And with the have conversations is patients.

X no Some patients options. or There them, transplant is registry, related potential they what choice. a no graft best is heard for more are we've otherwise don't sources their they transplant, the than are quite from which is choice have really is the any their do only typical would not who and receive really for who an seen other And for options. other other donor Omisirge physicians choices. really other of available donor graft And There physicians unrelated actually them. are have source choose patient who patients

some potential other donor choices, or mismatched either whom So Omisirge [indiscernible] as actually is seen who other have for best the there choice. or are sources patients

are are patients may may up. any kind donor of allogeneic or sources. transplant cell need divided These other how things stem So who not available and that's have

Michele Korfin

to back about going even just before we on spoke add just I'll what Ronit. launch. you, Thank

would ] the patients consistent and promise believe of generally Omisirge we increase access [ meet to that outcomes. with what are improve are We both seeing

at we're are eligible our is donor patients So source that almost approval. unfortunately, on access patients, consistent their source with the to seeing a the that as identified increasing data market we're where surge we Ronit option. able only but year each before transplant, had Omisirge indicated, side, X,XXX And through donor insights for least find that's not

the transplanter choosing And then the outcome a one transplanter Omisirge but has side, as for option. is other was Ronit where the identical match, half heard we've patient. another indicated, on case, the improving And option the in examples

in still encouraged are the of launch, what by stage we're Although hearing. an early we very

Gil Blum

right. All

inquiry out onboarded about of it bit reached guys? to reverse examples you with there a center of where was a maybe centers. So the dynamics a the bit Are where

Michele Korfin

Yes.

We clinical evaluated were the have patient to the part or need. had them. address multiple and appropriate those that option. not part the was some that certainly, out be for who dialogue expedite most centers But the they the in had studies, to transplant felt But able asked us, with who center of were clinical that actively to accommodate Omisirge we clinical reached one some would have transplant could study study, the who in which we we've case the the been of of active onboarding, in was were if particular patient being

Gil Blum

last Very helpful. one. And maybe a

presentation [ ] upcoming So positions? outreach And see ] know a you the I for above but kind presence at specific outreach ASH? to December I didn't have event guys to any physicians. you [ KOL in X. Are of going to have

Michele Korfin

Yes.

and Ronit. I'll So to I'll turn then start,

So a about commercial have at we have talk will ASH. team about Ronit will will our the book. and we speak representatives we'll from have launch at then ASH, the I'll president commercial a But presence medical. our

So as to either by. onboarded that have centers dynamics interact the the stop we onboarded. will or there, Gil, sessions individuals be are to the of the And scientific attend in please you chance with but developments, the opportunity have to transplant queue if from understand the you're alluded also and just to,

I'll discuss So we're forward medical looking San to to the side. Ronit to turn Diego.

Ronit Simantov

Michele. Thanks,

ASH. have presentation physicians as at we academic year. at folks ASH But dialogues this any a don't and we our true, have theater product So as medical individual with engaging well presentations do in group small

Operator

President the have [Operator for like reached to end would remarks. of turn session, closing I We the some Instructions] Korfin question-and-answer CEO, back and Michele the call to

Michele Korfin

transplant. in to Thank in potential increase all Omisirge confident to achieve market access a Omisirge's in across patients of for we We team's cell transplant increasing and you, to ability to U.S. need today. recap, Chris. of remain believe To cell in Thank allogeneic our an deliver its us patient centers joining ability stem stem you volume transplant the

everyone, joining look Thank further us for you, future forward today's and to updates calls. Thank on we providing you. call, on

Operator

that Ladies Thank may lines. your then you very event, much. you concludes and disconnect gentlemen, today's and now

Gamida Cell (GMDAQ) 14 Nov 232023 Q3 Earnings call transcript