CASI - Earnings call transcript Q2 2022 | CASI Pharmaceuticals, Inc.

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Operator

Good day everyone and welcome to the CASI Pharmaceuticals' Second Quarter 2022 Earnings Conference Call. [Operator Instructions] Please note this event is being recorded. I would like to hand the call over to Wei Zhang, Vice President of CASI Pharmaceuticals. Please go ahead ma’am.

Wei Zhang

Thank you, Welsh. morning. Good second call. CASI's XXXX quarter to conference Welcome Earlier details financial of issued a results providing the press release XXXX. Company’s XX, the ended today, quarter CASI for June business update and the release press section Company’s is in The Investor available of Relations the website. by led be will call Dr. Today's our He, CEO; Chairman with and Mr. Wei-Wu along Larry Zhang, President; Dr. our Zukiwski. Alex

during Medical Our will to available also Chief James the Session. Chief Officer; questions Q&A Executive Vice President Business Goldschmidt, be answer Dr. and Development they the Officer,

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

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

Wei-Wu He

concluding of and in you, I Thank call with begin China, Ray. Thank lead our sales had an And morning near of followed associated catalysts, programs with business on our which hospitals the by quarter will financial several lockdowns update highlights. the the EVOMELA. joining for and cities Wei. large thank In you impact restrictions, COVID-related to XXXX everyone. the second term in limited access you, an us. on Good

track. these our to address to by marketing of rapidly and strategies resilient, priority Revenues challenges, to the EVOMELA sales ensure sales compared is increased to proven that XX%, from be Our commercial to CNCTXX team with remain anticipated medical on EVOMELA Equipped of and launch the I year. adapt marketing in our believe experience ability China. from last a can team execute changing period efficiently environment, to the and adapting same

and soon. commercialization the of to of XXXX X very anticipate strategic the start be Phase the will BI-XXXX in to We continue China focus portfolio. development advance Our in trial

to NMPA during XXXX. trial We CTA continues. a Phase clinical approval CB-XXXX application, expect receive Meanwhile, CID-XXX study X our from the

are will In ten across we continue several in and of broad milestones the on May, reverse key our We ahead. shares. split to common portfolio effectuated our by to quarters the one excited momentum execute a company's

development explored entity on equity wholly CASI its autoimmune treatment for equity XX% completion treatment, make hematology-oncology As of a minimum second the stock equivalent the outstanding The and on be and Market reverse for and Nasdaq our plus the Therapeutics and of plus CASI. of The common of will XX.X Sub-license shares. result the company. satisfy requirement of its to million clinical reverse split, of agreement and future diseases. bid Capital potential diseases. listing two is stock continued will shares payment will to of of financing of approximately not the objective affect for price value CID-XXX diagnosis number the potential and incorporated shareholders’ the Therapeutics, in ownership granted share. Therapeutics percentage Beijing sub-license newly Tianshi autoimmune Autoimmune while of agreement previously with equal Autoimmune known Chinese the In exclusive Therapeutics, Precision Autoimmune upon sales is to prevention, will license worldwide we CASI – own the the Technology. first respectively, an quarter, a to $XX monoclonal market, Chinese million, an completion remain into through milestones, royalties for financing, subsidiary company, the allowing Precision established hold as antibody Precision allow installments of Tongda anti-CDXX upfront payments Upon Pharmaceuticals focused CASI’s second We of Precision will entered malignant be a split

EVOMELA. product commercialized first CASI's to move let's Now

for In sales We hematopoietic stem of second in to dose are pleased prior quarter EVOMELA China agent for the revenue in high as XXXX. to conditioning use report $X.X a is million currently of approved EVOMELA in in the melphalan EVOMELA least cyclodextrin proprietary myeloma at patients. China. only enabled with protection is cell available transplant injectable is patients multiple commercially a formulation formulation and patent XXXX, with until

experienced Our marketing the in hem-oncology and sales specialty major China a competitive teams is market advantage. in

transplantation in access substantial the strategy population. setting, established needs a on have myeloma CASI further multiple of needs We a similar to leaders efforts number cell to persistent treatment population. standard unmet high-unmet address and of our in with of advise the opinion adoption to physician key the marketing will working can patient this continues care medical the pursue us a who to as respect patient visits, to medical and stem continue of

Alex? have will upcoming pipelines. I Alex address our Now

Alex Zukiwski

This Good Zukiwski. like Officer product. Chief for to CNCTXX about I'd the Alex speak first CASI. Medical morning. is the CAR-T I'm

China and expect of CDXX in be. China our CMC goods, the CNCTXX subject we price designation as of non-Hodgkin's therapy will CNCTXX in which hematological Cell U.S. in with locally believe drugs partner, both In for China autologous which is The anticipated mid-XXXX, is of are CNCTXX, for components has developed B-cell be franchise January locally utilizing B-ALL the orphan cost B-NHL X commercial is is express the the a significantly manufactured, received innovative a the CDXX, outside manufactured NDA crucial sharing and point for the treatment in thoroughly investigational second XXXX. issue and part product in certain co-commercial of the Our China. Starting distinguishes program, pricing price to including CAR-T program and lymphoblastic higher this of being in we therapies CNCTXX other in CASI developed profit imported making Juventas Juventas filing directed by lymphoma. Therapy CAR-TXX CAR-T development for of prepared manufactured developed drug from to registrations which leukemia, FDA. other CAR-T will and currently be cell malignancies, the developed and higher ex-China B-cell China half than rights. indications. patients. CNCTXX of patients CNCTXX the Phase continues undertaking potential an CDXX currently and acute Similar, which being has and

that for product candidates checkpoint-targeting Now antibody address the novel BI-XXXX framework of with in BioInvent, lymphoma. includes progress have we two with monoclonal RIIB regulatory liquid Phase lymphoma RIIB X/X studies. for cell patients potentially follicular, to market. One used marginal CTA which antibodies in BI-XXXX otherwise with and cell BI-XXXX mantle anti-PDX monoclonal action in licensed rituximab. is solid and the is directed-targeted The therapeutic solid evaluating with in Fc can or as for gamma investigating me gamma are BI-XXXX relapsed combination combination currently treatment used to in the A blocking Phase granted and/or partner, who efficacy immunity all the a the X/X inhibitor human the China as of tumors. efficacy. approval continue let known unlock BI-XXXX, to gamma non-Hodgkin’s rituximab pembrolizumab targets CDC outside antibody BI-XXXX BI-XXXX Keytruda, NMPA in checkpoints pipeline. our along second therapy trial for rely to BI-XXXX refractory modulate lymphomas, we Earlier in has immune common is inhibitory and mode The slow growing receptor on China. China. lymphoma, Together tumors hematological the growing for our development first-in-class that BI-XXXX status greater with greater develop development plan antibodies investigated the both in non-Hodgkin's BioInvent, other malignancies responsible China with to that commercialization the single tumor-cell solid in immunotherapy. the cancer We Fc continue and form the anti-cancer the BI-XXXX antibodies and for December Fc checkpoint antibody tumors. be being in receptors of of – of are the both U.S. FDA lymphoma and most XXXX. in treatment the granted of slow ADCC cancer BI-XXXX of year, this follicular orphan for drug

in the this BI-XXXX lymphoma. Our relapsed/refractory in and lead patient half patients has we second of BI-XXXX dose rituximab to year. in with The the indication non-Hodgkin combination first initiated, with will been trial expect be

and targeting acute to we a CB-XXXX hematology/oncology pipeline target promising with agent we’re is worried CB-XXXX. CB-XXXX in addition selectively complimentary to Now about assets. for VCP/pXX Therapeutics, our Cleave partner, a in develop represents the our initial myeloid indication cancers, plan new package from IND Together potential greater for CTA commercialization development application multiple Center and China. CB-XXXX on in indication China is responsible CASI in myeloma progress Evaluation. the Drug the as input leukemia for the after the The with for additional of receiving

is trial in Therapeutics responsible Phase evaluating AML the Cleave and with partner and myelodysplastic patients Our the clinical CB-XXXX syndrome. development in of molecule is X for a ex-China

our are the development development current by trials indications joint in of focus by and China. new potential on to We the CB-XXXX for initiating the excited accelerate program with helping

anti-CDXX monoclonal X maintains Phase has expected global activity multiple The is with previously escalation in June preclinical recognizing profile, other for on multiple treatment short epitope discussion enrolled short of compared – a In a XXXX, unique is we monoclonal fully safety exclusive IGTX, CID-XXX for CID-XXX demonstrated Now is with human CASI our the developing antibodies. myeloma. a patients anti-CDXX Phase study. trial valuable of that a early encouraging UK. clinical evidence and dose or to and X in to rights CID-XXX. to Phase information study myeloma. in France generate myeloma with The provide in patients relapsed the patients patient treatment ongoing is the in refractory multiple first treated X currently and has potential the of antibody

responding of to the our Thiotepa on This we Center the to will response the Evaluation of regulatory update for final pipeline Rui to the an over completes China for process turn assets. I the now in financials. update on it Rui? Drug provide to submissions two indications. Lastly, are key

Rui Zhang

EVOMELA. for quarter June year. XX% quarter briefly Today Alex. XX, Revenue increase compared with of results key ended second sales of and you, provide product Thank to was the for consistent $X.X is million ended quarter highlights June XXXX, our $X.X Revenue this summarize of I XXXX. XX, will for financial million the

deploy with By agreement and revolving into creating a management continue questions. our Welsh? be cash line loan to to call to open East we that, to the same working XX, turn and year, million With the Costs I budgetary the $X.X for up in operator XXXX. capital cash entered Secondary back of like closed the business West and now was $X.X million on which in the focus a In $X.X May, line We control, for million quarter quarter for ended the EVOMELA million with of million royalty quarter revenue for lockdowns June COVID-XX period includes XXXX, of cities the to few the slight in the China, $X in of to the the of $X major last was compared payment revenues $XX.X quarter same first the XXXX. borrow compares second on to for over how to period US$XX to Bank million we this cash thoughtful million with value. would credit shareholders' equivalents. implementing up we purpose.

Operator

Thank you.

will question-and-answer ahead. We begin Please Instructions] comes [Operator from with now the session. go first Justin Zelin BTIG. question Our

Unidentified Analyst

for Wei-Wu, Thank Hi, taking Justin. for on you our [indiscernible] questions. this is

Wei-Wu He

Justin. Hi,

Unidentified Analyst

two had questions. I

is first is if you the in you The clarity provide a choose Precision struck question if about will near you this Precision obviously the attractive the deal What seeing And and second challenges you due you. resolved congrats could recent this Autoimmune are with you Therapeutics. to future? as the Thank believe did COVID did find you be and deal partner? on on Autoimmune additional why

Wei-Wu He

back. know for that's major the really the our this impact be COVID again. least down sure finish the don't part situation, situation major But of our won't cities, more I quarter the COVID this is at COVID this China that is because specifically. Yes. Justin address was on happen policy revenues. regard, of coming control. obviously and hundred Well The a far, after for a two revenue Shanghai, major quite Shanghai in second in for unpredictable Shanghai We is is percent can May shut some so probably literally Larry with months revenue. actually

impact So, question, you bit want of do on this Larry, add a revenue? COVID on little to the our

Larry Zhang

Hi, [ph]. Justin Absolutely.

of one and is not it the and further China any key ready the big do. can still say, predict, it's team and is in and we for new wave for alert. rest COVID-XX, for revenue. summer would of it's Shenzhen and in are is is our pretty even yet. again anything locked are that COVID-XX This policy can a As challenges, in we and with. deal and something always our is Guangzhou unpredictable again, ready I is mentioned, like and ready the that in city impacted I Shanghai, cities for it and to sales forecast we happen of the And But But the happened we down. is And year the sometimes, and time business though think, it's

to for deal grow challenges there’s and the ready XX% last ahead. that's lot can same with. a businesses our We're continually So, three the compared But period quarter years. second of why, to

[ph]? Justin

Unidentified Analyst

Great.

Wei-Wu He

second I do [ph], you think think question we satisfy for the first question? the Justin question, your

Unidentified Analyst

Yes, that was great.

Wei-Wu He

Yes. big The a China country. is is thing Justin good

we to that although So, year, sustain previous just still enough the means beat country country, quarter but it's the one diversified itself business. is the the that

your We to that do commercial team. focus market, have Precision to a do have question, senior because, Therapeutics? we we CASI second why answer and made management team, going So is a the the hematology-oncology on we have board wonderful Autoimmune commitment the

very have wonderful company marketing still have KOLs, limited resources. we financial are a with we small very with We cells, connection but

hematology-oncology space. on So we are focus just going to

been treat autoimmune encouraging. really, actually autoimmune disease, have the used So, off-label. quite in indication all data And to CDXX is know different that many really the we

found local capital they willing of the are and love just finance autoimmune venture we story believe like space. just fund precision is a CDXX the autoimmune a diseases we autoimmune And fall cancer. So with company, in kind to on

driven ITT, like are lupus, really one they different actually biology. instance, not totally they're by like For diseases disease,

and them T-cell by some D-cell, driven later Some technology. them cell the are D-cell are early them driven of more, driven some this is plasma major actually sequencing are them space by by of driven single in biology, breakthrough the genomic some cell. of the are stage think technology We by of also technology, biology,

with up who edge the technology. University analysis leading single really, Peking teamed So is cell in at professors really we of

And ocean by our settlements indications. potential really autoimmune cell brand autoimmune the and of this part contributing almost studies, since we X a far new, technology think like this data. we Phase So, is CDXX CDXX, of blue single treatment. up our for being opened extremely are new precision cell We exciting is so our finishing clearly, lot

pretty have high reaction So at even infusion no we dose.

for That's new And need could do bear so, development actually our why develop to from drugs deal. of financing burden in help indication, diseases. not autoimmune NewCo hematology-oncology CDXX spend with money clinical to we to CASI this does investors, additional indication. autoimmune the will these the But the which for decided

Unidentified Analyst

Great, so thank you much.

Wei-Wu He

capital And have low interest from we million, existing market. think about XXXX. payment, a receive which Bank. with significant upfront this $XX will today's $XX West pretty And actually is on we we cash. million loan also East CASI we got We very well for depressed into And rate are financed well

Unidentified Analyst

sense. Makes Thank Right. you.

Wei-Wu He

Yes.

Operator

Our Please next question Leland with Oppenheimer. comes from go ahead. Gershell

Leland Gershell

Hi, good morning.

Wei-Wu He

Leland. Hi,

Leland Gershell

made Yes, Is could Hi extent the to what availability first, NDRL? timing hoc? that potential of be there can activities you the increase literature you on expediency be my at likelihood And would CAR-T or do anti-CDXX to question or or CNCTXX, consider NDRL year for ask you have Wei-Wu. the a as on is second to would looked these progress. And anticipate the CNCT the Is ad Hi. does can if thank is visibility, me something wanted being congratulations – evidence once that in therapies of China. many additions there are NDRL the the Two questions. is questions the any be look the of for cell we on listing. the you frequency, only any many, certain then taking in a Wei-Wu this there

market? to just to many those you Thank yours the of shut wondering some and I on maybe you. about at application. government academically, yours with those of those have Chinese or the once are we them competitive CNCTXX be think think terms used status in do the down the what Should commercial we think of of point, also I'm probably ability in addition as being would pharmas.

Alex Zukiwski

thank you indications is to in Yes, Leland NDA CNCTXX so mean, XXXX. the I track with all on Juventas much. was file still, still

So way always that's that. have saying we the been

significantly that of produced point X.X are close happen to CAR-TXX, most in it's around Before the going highest, very to which only from is CAR-TXX they at sufficient is going There manufacturing likely to priced CAR-TXX we therapies. most see of to is developed RMB approved. available the end base. US$XXX,XXX, approval CAR-TXX, about significantly at imported are is U.S.A. if is also data is Chinese million really But end so U.S. likely client kind if Juventas agrees investors XXXX, see our approval competitive. CDE lower highest not domestically in price and CAR-TXX of approved XXXX. we should One with the than all our be our more cost our But two a high believe happening is comparable, China, Because CAR-TXX The to Juno's NDA is filing. data, expect

there So, price a there is will advantage be – in we China. a think

Secondly, Juventas, because commercial for have so sets prepared launch a the of believe we and sales of CAR-TXX do as that experienced in EVOMELA are very already team KOLs for we much a for EVOMELA, the treatment. and CASI the collaboration We KOLs through between China. same channel are the commercial of because CNCTXX

So might question? The hopefully that but And China. answer the Leland, probably or be is domestic going not in be the more consensus coming. China. does than to will in number your five CAR-TXX be first there three, drugs CAR-TXX we approval additional it's four

Leland Gershell

Yes, helpful. Thank yes. That's you.

Operator

Lee with Instructions] next H.C. [Operator from Our question go Wainwright. ahead. comes Sean Please

Sean Lee

on morning My CAR-TXX. Good questions. first thanks the and my question guys for is taking

upcoming to I be that was later the of steps of you're terms next expanding in in year are to the Thanks. your need able launch this this and commercial manufacturing terms additional year, with any results or wondering, So potentially structure? there approval before taken

Wei-Wu He

repeat you the very Can well. Sean. last couldn't it Sean sentence? catch – hi, I

Sean Lee

get Juventas approval you steps need to to For year, product? the there you're go before next example, and wondering, you have able have that manufacturing year Or we to that was this commercial expand positive to the or you checks? I through take are assuming additional any do Yes. other do launch results structure?

Wei-Wu He

capacity which year, understanding the My X,XXX patients, patients sufficient least at expect we first to first have for the least the manufacturing year exceed at first X – X don't years. is we X,XXX in for to

issues anticipate approval. So don't any we manufacturing at

job, such have X,XXX might our into patients, invest commercial additional capacities. manufacturing to did it's great if a actually we team Now over

Sean Lee

on my for Then side. the question second is clinical Great. pipeline

data well idea could as expectations Just for BI-XXXX Thiotepa the an us line time development? the timeline of for you give the for as

Alex Zukiwski

Sean, this is…

Wei-Wu He

like Alex, address to that? would you

Alex Zukiwski

Yes.

is Sean, Alex. So this

final all that We with working ESTEVE, are able On Thiotepa, to CDE in it we majority partner, fashion. recently a timely questions. the the our And the submission back questions optimistic be of we will be to the address from then We're CDE. will address received of to shortly. hear a process review anticipate vast

Some little will take a longer.

the within that have of have analytics done. But hope that. be six – would feedback that the submission four will complexity Secondary to a new next and on months to we I

moving program BI-XXXX, On the that is forward.

I in noted, CTA the As has China. approved been

have BioInvent. is goal patient the possible. We study close combination And And the as at plus very the participate ultimate to is colleagues first BioInvent BI-XXXX goal for to collaboration our as expeditiously registration in rituximab. future of in the our get a global with this

Sean Lee

clarity… Thanks for all the

Alex Zukiwski

of give on not these I you and – BioInvent. we'd firm But apologize in we yes. with things, collaboration some that so announced have do but only to dates

Sean Lee

have. enough. enough. Thanks. That's all I Fair Fair

Operator

ahead, over sir. like the conference the session. Wei-Wu remarks. Please to go would to turn I concludes any for This back closing question-and-answer

Wei-Wu He

program, today's in biopharmaceutical pursue We existing observe our pipeline for the for Operator, of the again you. are forward this There's in infrastructure, course strong to commercial to during your We continue CASI revenues. company. continued you period. leveraging thank drive and mind in each that my we steady look pre-commercial a EVOMELA support you call. exciting for launch fundamentally expanded joining activities doubt no thank CAR-TXX thank progress building Well, on

may conclude You this call. now

Operator

for Thank attending you. The conference you has now Thank presentation. concluded. today's

disconnect. You now good all day. a may Have

Wei-Wu He

you. Thank

CASI Pharmaceuticals (CASI) 12 Aug 222022 Q2 Earnings call transcript