CASI - Earnings call transcript Q3 2021 | CASI Pharmaceuticals, Inc.

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Operator

Hello and welcome to the CASI Pharmaceuticals, announced Third Quarter 2021 Financial Results. [Operator Instructions]. Today's event is being recorded. I now would like to turn the conference over to Jacob Moshel. Mr. ahead. go please Moshel,

Jacob Moshel

the Zukiwski, Good Relations Earlier welcome CEO; press our today, of Today's led Business available results the operator. This XX, quarter release Dr. call available of press Medical Vice President; Wei-Wu along and with release call. the CASI's the during by Chairman conference details our is Senior Mr. answer for financial portion be company's to Dr. will call. CASI Dr. Development. and the the of ended morning, our Alex Chief Officer; you, our September be to Jim XXXX. this Zhang, Investor and in Larry third providing quarter He, questions Q&A section Thank All issued Goldschmidt, website. a will of President company's

will a not statements. and These are forward-looking forward-looking subject risks include uncertainties statements, remarks implied including differ a These to cause results materially or statements and that not forward-looking you to our guarantee in performance, As those business milestones. from upon actual statements numerous them. objectives undue future reliance projected therefore, reminder, our and today are plans, could our put of should

turn He. could Dr. call For in CEO, you to to to now over description our is and cause our to He? Chairman Wei-Wu SEC important a the factors differ, of pleasure that my statements results our actual we refer Dr. filings. It

Wei-Wu He

our covered highlights. we and to near-term any the the Jacob. our programs focusing with followed questions update, you remarks. not happy joining in by a on session you, for us. I Thank morning, call are third will That begin everyone, Q&A Good answer thank financial our and lead during said, quarter catalysts, general

of which continued progress in and dedication We of functions focus. third all I'm been the made all very pleased team the our for quarter. with And has proud are their

executing strong are innovation address globe. likely around course pharmaceutical The a is to in in innovations medical the and meet needs building bring interesting medical China company. specifically, innovative our to unmet initially on a of financially global aging solutions the mission to More we lifetime. leading medical needs well strategy, population. are our We strategy CASI's most unmet is opportunities one China's leveraging of the the

First of all, world's population. largest China has the

Secondly, China's strategy innovations. one product the developed time global with at in economies, progressively patient global clinical with an provides unprecedented market. development pharmaceutical life-changing such deploying an process is to hence, a patients hematology/oncology is to the advanced population trial a initial resources focus products bring harmonizing for CASI the

to We will strategy ongoing use our product execution. and our pipeline illustrate

to were is The first EVOMELA successfully we product in to able market China. bring EVOMELA.

commercially EVOMALA available exceed report Based a increase the myeloma. approved remain year patients revenue China revenues prior growth, of the injectable stem to growth XXXX It to in XX% treatment as conditioning ago. in pleased in we confident a for China. over continued is on third year of use the quarter, melphalan from XX% $X.X XXXX. guidance is transplantation are We million cell a our on high-dose hematopoietic full with in for to form multiple EVOMELA for

and completed prior XXXX, it treated protection with report market not formulation least KOLs of we were adoption versus a proprietary just in China is with being the patients study for until to X and the melphalan, drive has The a accrual, post-marketing is is closely finalized launch study clinical for X,XXX EVOMELA at Following our submission. EVOMELA XXXX. EVOMELA. patent than awareness market. Chinese EVOMELA's the more worked launch, in expedite year, In EVOMELA to XXX first

sales prepared and team commercial and successful [indiscernible] are expected, have commercial built have are of EVOMELA. of XXX launch specialists studies first marketing the China. EVOMELA, Through consistent seeing as is a product medical data hematology/oncology far our in to published with strong assets. So our the established we commercial launch we more They with themselves than future

Our market a for advantage competitive and hematology/oncology China is specialty team CASI. in in major sales high-quality marketing

number access We unmet of on KOLs who established patient the to of have a can us substantial our needs advise population. medical

our its trials. also for Juventas, to the becoming With China. are our partner partner CDXX progress few We biotech companies have words regard continues in make choice A excellent no our current of who innovative ongoing CAR-T, presence with XX. about to CAR-T

as will for is express may be Comparable Juventas making product of and which been CDXX, CNCTXX you autologous important and in an and hematological particularly manufactured which and CDXX and global other components has manufactured B-ALL are higher is B-NHL. profit-sharing very that developed developed potential developed from a be patients is we China goods, CNCTXX CASI greatly subject ex and the issue China, recall, part to distinguishes it being CNCTXX are therapy with where pricing cost outside and outside CDXX treatment manufactured priced. price China point CAR-T can products. significantly high to locally, including for premium patients China. XX Drug investigated As CAR-T therapies and rights. of cell in of certain which a by has commercial therapies CNCTXX malignancies, believe developed innovative for CMC than

it the believe is raised completed therapy which to through in continue million, adaptation which financing CAR-T RMB will XX China. partner Juventas USD financing more our Juventas this for recently approximately allow XXX million. than a Additionally, of bond Series C We

to continue encouraging NDA is very find and in to XXXX. activity see NMPA We on Juventas track with

treated relapsed cells patient assets. preclinical is monoclonal recognizing favorable has is selected encouraging and a safety epitope. or previously efficacy, a activities our It with cytotoxicity unique I dose with anti-CDXX key cellular anti-CDXX refractory Phase malignant CID-XXX address cytotoxic CID-XXX than in activities, treatments. shown the a preclinical antibody, with greater ADCC to activity escalation This other a anti-CDXX multiple infringing in will June, first profile study have myeloma. against reactions existing CDXX and In expansion strong a was IgX patients CDC of antibody-dependent positive anti-CDXX. study. CID-XXX, potential I a antibodies. human Next, observed reduction other reduced fully -- and our with enrolled previously is

in receptor, with BioInvent monoclonal BI-XXXX. XXXX, antibody patients further long-lasted partial single market. the hopeful an for rituximab in-licensed the action, responses all X the and trial with blocking a antibody responses data In a with responses obtain clinical BioInvent to without centers completing monoclonal antibodies tumors checkpoints I/II can October for X multiple a is the for KOLs, a XX beyond will in of be appeared targets BioInvent, checkpoint XX benefit. trial will enrolling We on complete translate has mode are CASI modulate accelerate liquid additional to patients. in BI-XXXX with patient and gamma in be China cell combination pharmacies also efficacy. and lymphoma. patients leverage Phase and tumors lead commercialization BI-XXXX, anticancer that is ongoing unlock existing of X trial with commercialization therapeutic used hematology the for RIIb The to in This KEYTRUDA combination the receptors therapeutic being RIIb XX provide treatment disease X anti-PD-X BioInvent expected of ADCC/CDC of to for evaluated immunotherapy. Previous the seen months trial rate investigated targeting and stabilized gamma dose China. in responsible X first-in-class evidence novel liquid had medical non-Hodgkin with Fc potential including potentially and that plan inhibitory both gamma has disease hospitals, and clinical Greater study. a Phase development Together Cohort into both of myeloma. development in in announced we great expertise, valuable teams directly continue positive the with Fc with these BI-XXXX treatment currently fully-human greater cancer with and control by China. a that is response and candidate develop in of treatment to I/II rely antibodies receptor is I tumors. drug with Recently, tumor benefit. rate in in XX% We solid we treatment July and of solid BI-XXXX BI-XXXX used immune BI-XXXX XX%. to the BI-XXXX in established plan solid that Phase immunity objective demonstrated medical escalation and XX this checkpoint of in Fc given BI-XXXX generate combination patients failed from Phase sustaining antibodies in relationships cutoff and rituximab efficacy targeting are early our activity in information and in patient antibody to to in complete rituximab The

in submitted BI-XXXX Our with lead in be with has relapsed for XXXX. with the an combination R&D NMPA patients BI-XXXX rituximab refractory indication in NHL. will CASI

Next, assets. CB-XXXX Together X a with quickly with I an initial Thiotepa. in in [indiscernible] KOL cancer target we the to Cleave's is by our in have potential key Cleave, with supported CB-XXXX as and an development prior small to patients continuing develop the AML in approach inhibitor high-quality, for for CB-XXXX as for and words conditioning stem pXX was look complementary assets. licensed not in [indiscernible]. focus XXXX, Thiotepa indication including responsible indications through plan Thiotepa CASI oral leading acquired trials is XXX In CASI We commercialization Greater second-generation trial cell high starting a a from extensive CASI This jointly for chemotherapy market. progress. [indiscernible]. first-in-class a dose authorization. possible by submitted still China. our has CB-XXXX use completes AML research Thiotepa for after to helping pipeline Cleave regulatory CB-XXXX. and pXX to update has note, regulatory is new pipeline current in a hematopoietic introduced by hematology/oncology early currently with pre-IND in with clinical inhibiting development joint for Thiotepa novel a selectively agent to China. Thiotepa, the preclinical program a product treatment our CASI potential injectable currently few Thiotepa indications indications, of CB-XXXX is MDS. The are a pXX addition and our China assets we from evaluated on China. new as data. and as a is the Phase a form accelerate Greater forward study multiple being registration on CB-XXXX, to the targeted on in of development March Since hematological clinical China does transplant. molecule, promising inhibitor. Therapeutics to submission initiating represents of progress malignancy in our

few a highlights that, on With highlights. third quarter. financial our our few financial a words give will I Now for

$X.X for details EVOMELA consists which XXXX key September growth same read Our X product percentage million Rather in decrease by Revenues excluding ended million X ended includes $X.X for $X considerable million the revenue alternative ended XX% for revenues a compared of the third XX, X was months XXXX, the our release royalty, of results. months and and XX, inventories and to place, XXXX, $X.X comments was Cost $X.X Cost in of my XXXX million contains compared significantly cost for EVOMELA. in the highlights. And XX, was the press unit $X.X of quarter million the X quarter continued in these of address period. that XXXX resulting months cell. of revenue, in of more the September compared as XX, million due September X of of September sales today XXXX compared royalty to manufacture million XX, ended to of September ended months of the to Revenue XXXX. in financial XX, in results, than revenue, the X $X.X royalty the EVOMELA of as XXXX, cost months for through XX, increased million September XXXX. to months due in XXXX, the decreased payment $X.X launched X the ended ended months XXXX. same Revenue for the will all excluding September with the a

XXXX. has As company the the December as had XX, and CASI the equivalents rate, million its XX, of run of million to compared fund operations resources $XX.X cash cash XXXX, to of sufficient September At beyond XXXX. current $XX.X

thoughtful extremely our on value. position be on cash continue a We we deploy focus shareholder to building how with

Now to and I will operator question turn answers. the for

Operator

[Operator Instructions]. with question comes Leland And the from Gershell Oppenheimer. first

Leland Gershell

the on about in China I wanted to ask commercial ground. organization the

or had with be expanded CNCTXX been that also If as you the as on may how growing we may want could think kind pace question you've business date way third-party of to a of a to sales? of that expect deals to the to into further to get makes ask to and development should be organization deals. respect we Obviously, series additional continuing these we CASI? How to how should continuing it EVOMELA us you've about about the of same? comment grow for XXXX, think types I expand have nice those been have BD market. And should should

Wei-Wu He

revenue of which in we is, the X, we Thank you us growth. this niche our in commercial team to the moving EVOMELA our commercial XX our aggressively very team, commercial believe of the unique for pretty We a million actually, so $XX revenue, a product. drug, strategy believe launch. commercial the expanding huge put EVOMELA of year very beauty of will first year preparing do CAR-T being beyond much. product, -- a we forward cost actually Well, in team The as team position. the so cover are China, all, X, not first EVOMELA, And maintain

the growth to prepared next potentially team additional and launch product hematology/oncology is in really after. our So year commercial year

with profitability. So one launch commercial truly achieve we building product to product in potential And engine the after we hopefully, another. are China second probably launch, a will

that don't question. I So if know your answers

product for our and expanding regard is in our still that So future is really to team prepare launch.

kind picky first of a in literally the the our It we're licensing licensing, startup what in of is very was are to on to we we fit because product terms want really CASI Regarding company. market. product

for to we with be extremely at can look commercial want strategy. when look So synergistic asset, the really global we asset our

commercial KOLs doctor and day very our be commercial doctors using in XX fit Thiotepa. will well using over same because likely talked These day. to CAR-T the all XX Basically, team So launch our our the will of the -- the EVOMELA X products same team CAR-T commercial pipeline is EVOMELA be and most people Thiotepa. with using the the

really So products commercial lot of we can into looking are this engine. for fit a

it, will down. bit while lot be after optimistic. might product slow sense, a we little we don't we we in a -- pipeline, be will good a When fix be probably of will a aggressive. we So our if see see we But

ideally, answered call tremendous defined in the potential. So pace we don't really hope do to have like look question. product a license diamond. we XX for How upside But a carat what sense. I the your we'd we has that I

Leland Gershell

helpful. Yes, was on congratulations the progress. very And

Operator

question And the next Lee comes H.C. Wainwright. with from Sean

Sean Lee

great Congrats on on My question first quarter. EVOMELA. is the the

were XXX that to mentioned to last you compared X,XXX prior year So patients EVOMELA launch. treated

for you X us you months is And So year? -- many limit were on this update indication? in patients this could how of many treated the first do much how the how upper think

Wei-Wu He

year. for we this treat Actually, whole year, about planning patients X,XXX are to the

exact the number the X first exact Larry, months? the for on quizzing do you're me so number. know And you

Wong Hu

treated that a already. X,XXX It's patients we almost

Wei-Wu He

Yes.

So X,XXX.

XX,XXX goal the current to our is per patients So year. exceed

of there's lot for there's a orphan some other this indication drug. -- for So utility

people. autologous at current million now. So with transplant actually potential in more are we at China is least does China XXX XX,XXX the in over patients billion than least year. more XX,XXX But bit obviously, for X.X for U.S., people, indication, the much than little a has bigger the U.S. because targeting per

believe lot drugs. And EVOMELA to is that priced kind be a so probably a we premium will be a of considered number But still higher. the ultimate

are we over much penetration reason right EVOMELA. probably in As be will goes living Chinese patients higher. exciting the standard the But targeting China, this people's XX,XXX for now, is up, it's think as we very one market

Sean Lee

good My to next is Juventas question the collaboration. That's on hear. Great.

that this year So think of they this by nutrition previously, I studies the to you year. next mentioned some expect complete of enrollment and end

year? they I still submit And So before we track? the whether next data see was to on releases enrollment any wondering expect whether can

Wei-Wu He

Yes.

has Juventas, for we year. more market. because -- are required on we XX be to necessarily the We enrollment we the CDE for complete all it's know X since by to the still this track moving China updates, lymphoma may B-ALL market, approved enroll lymphoma know CAR-T far And don't the for as as patients

think be B-ALL trial of we by So the will Juventas. lymphoma ahead

so looks of least to end next So by complete B-ALL, it's like the still at for and far, track it NDA submit on year year.

Sean Lee

Great.

those In have that learnings terms to those had in of are launch any there help products? do you prepare in special And special commercialization, anything anticipation of smoothly. you

Wei-Wu He

is market. the this the detailing XXX -- the have the So by for drug already CASI than salespeople, same approved, KOLs time is field more probably

lot preparation, of drug. the before there's of for launch we but one preparation the a that's So --

we because team our So in preparation we than think is our team. kind space experience in of lot our kind in hematology/oncology space. a better We the will really in advantage. competitor an -- EVOMELA much position will China we of be doing we launch already nitty-gritty think a And have we this have of are so this a in launching is the And of specialized this market. by

Sean Lee

more on final makes BI-XXXX. question My it is clear. That

updated with for updated are steps? So plans -- the what the the your I with positive results, next Phase

Wei-Wu He

I didn't last catch part. the

Sean Lee

Yes.

of plans drug your the are clinical terms the what next of development? in So steps for

Wei-Wu He

to are Alex, you call? our leave CMO. Alex, on the I'll Yes. it

Alexander Zukiwski

on I'm call. the Yes,

good So near meeting question II future. of as forward collaboration the program for we to in address a equivalent been is IND in relationship BI-XXXX, very the always with have the that BioInvent, completed And has established Once the we moving planned with Phase we'll China. end potential FDA proceeding with outlined that's they're BioInvent. a for be along filed

PK/PD required with join somewhat the programs forward be have will will we registration move truncated after in a global which And will BioInvent. so that conjunction we to anticipate study, we that Chinese-specific

Operator

BTIG. Zelin comes from question with Justin next the And

Justin Zelin

robust EVOMELA, especially sales the Congrats quite on guys, impressive.

you're over -- to that mentioned sales grow continue to let's You X,XXX XX,XXX. patients from, planning to grow say,

So the more Will of some additional that? sites additional it it geographies outreach? be maybe just if there. that system trends the And more you KOL to for kind in that you Or EVOMELA. the speak also could targeting Or are EVOMELA mentioned, can indications and care expecting China. appreciation you is of as you're of health use

Wei-Wu He

the in in autologous Well, is a for is launched all before China transplant think of XX% intervention therapy. can XX we People better kind unit use It's a to People Because a current of is patients myeloma. transplant is of China, commonly transplant. life-changing think autologous test available treat the EVOMELA, a lot Because really hospital. patients. right agent the the I previously, that -- the been -- and of bottleneck not multiple actually developed the of preconditioning we doctor a But used biggest the of intervention other transplant patients so transplant we kind educate actually is kind around for have because to now, was in using new live has has of the others. much -- without [indiscernible] kind drugs used years. lot by for to doctors not

really path kind frontline to is is treatment. the transplant our patients lot So doctors for of of reeducate a the that

physical So that's the have this hospitals the that's a And of don't treatment. transplant type really China, of units, probably hurdle. lot the -- to do units sufficient

So direction. are are the trend this but in hospitals seeing -- that we new expanding encouraging all

protocol the we in the to communication Does a with seeing for using slow sense. this going answer are doctors, your that question, graduate it's encouraging very So and trend Justin? be

Justin Zelin

noticed there makes have CAR-T in price on trends the of there currently? the my any is Has much very that's that available just product maybe lot Or with cell of And currently uptake? of helpful, been Yes, any kind pushback a and to for you last sense China? question, therapies me. it

Wei-Wu He

Yes.

XX. is priced the So side all from is which China expense X.X which population. from the above X CAR-T XXX,XXX, has RMB it's Chinese believe And other for million, about approved One on USD [indiscernible]. Kite, we the are they is

And to know, these the think the probably high after it's been largely as I end, price be far now. time approved. be believe But the the China. will China, of less -- due treated is is patients this treatment significantly therapy to going at it's take come eventually, current drugs price as XX probably pretty -- our We some out this X hurdle. So a in being price in in less to than down. will I I we we believe the for the $XXX,XXX adaptation the going And X than think have drugs type high that of should that pocket

Operator

next mute. [Operator from the And with comes phone Instructions]. right. the Apparently, on All must be question

So does question the actually session. conclude that

to comments. would this to return for at like I any management So time, closing

Wei-Wu He

for again you call. joining Thank today's

portfolio. We far as have had across a progress with remarkable hematology/oncology our CASI year as

infrastructure will We continue what we existing would be to initiatives. forward We forward business development on we leveraging by move expect as encouraged key to be look forecasting. commercial our

we and of forward product this Operator, period. for in passing thank you thank each this near conclude to looking during you. future. -- So in additional to would launches We are exciting call. support We the may like continued now your

Operator

Thank Yes. you.

concluded. Thank today's conference the mentioned, now has presentation. you for As attending

You now disconnect your lines. may

CASI Pharmaceuticals (CASI) 13 Nov 212021 Q3 Earnings call transcript