CHRS - Earnings call transcript Q4 2021 | Coherus BioSciences, Inc.

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Operator

Good day, and thank you for standing by. Welcome to the Fourth Quarter and Full Year 2021 Coherus Biosciences Earnings Conference Call. [Operator Instructions] Please be advised that today’s conference may be recoded. I would now like to hand the conference over to your host today, McDavid Stilwell, Chief Financial Officer. Please go ahead, sir.

McDavid Stilwell

operator. you, Thank and everyone, for us. joining Good thank afternoon, you earlier XXXX fourth We issued and our release press results. our quarter announcing full year can the on be website. release Coherus This BioSciences' found future statements current Today's regarding includes forward-looking expectations call about events. Coherus' and These future, statements to, to product expense registration, ability our products SG&A advance to candidate and product not our clinical candidates in development timing status and our commercialization same. XXXX and through ability ability for product the and but meet include, to are R&D limited of the profile, candidates guidance our our our the

results, Our achievement the With call as as facility, turn that Office. to to are could me no Development and duty uncertainties Denny statements results, call performance press in this down today's forward-looking file all report are and performance statements. on forward-looking drive in will to LaVallee, our Operations guarantees statements. including from Exchange EVP Securities the in our CEO margin beyond date, the we or on and projections the quarterly that I credit now involve cause on amounts those Paul certain These provided statements actual by undertake which made and Theresa annual are about and forward-looking we and as of of risks Form update are And Reider, substantial well that on document as and as with risks our ability of issued Commercial Denny. differ XX-K control achievement of and new today, over of The future to any Form discussed Commission, or report XX-Q. subject today uncertainties call well revise or Lanfear, are the Coherus; not the Chief under implied are our that to we performance release our

Denny Lanfear

our diversified combination afternoon. immuno- brief an review toward you a we've of Today, our us thank by objective into the progress with orphan review for assets from carcinoma builds we first cancer. indications. non-small for for November, across plans with also pharyngeal supported all antibody and details in toripalimab, stage that immuno-oncology robust a I'll of describe they're company stage which survival analysis cancer have Theresa designation. first for clinical lung progress strengthen Then TIGIT-targeted an our one portfolio our Toripalimab’s the statistically And options, over Breakthrough our is recall Development made LaVallee, pharyngeal benefit this the esophageal to innovative with past initiative review year the option trial toripalimab process and oncology on date in joining for nasal nasal overall cell carcinoma, immuno- profile our where our a chemotherapy progressing developed how action mid target December, our for Coherus well announced towards will delivered Dr. of toripalimab plus and BLA In begin line our McDavid. and our squamous portfolio. January, XX may clinical survival a indication today of cell drug achievement programs, seen choice you, new the BLA recent I’ll In demonstrated of indications and provide progress review treatment Detailing for stage a XX, now. overall you Therapy income Thank which partner, has April transform our JSXXX, toripalimab study additional treatment and oncology. from approved grow in initiated in clinical This development IO and just I’ll the we line our FDA the continues Biosciences, a about We've immunotherapy no strategy. Officer combination Chief both foundational products. of and JSXXX toripalimab. exercise advanced other The Junshi evaluated the diversify survival. FDA by in is commercial which asset in carcinoma respect days clinical preclinical with With strategic of interim moment. progression you priority and granted pre-specified about we benefit we a innovative to announced agents. that free license FDA to significant to to approved

blocker January, PD-X immuno-oncology, candidates Theresa? regulatory for in pipeline the and provided the from In XXXX Dr. we therapies proven leadership she highly XXXX. a expect team, expertise. growth Institute candidates long-term was establish Theresa appointed was the development LaVallee in-house of member than to and into to President and is Translational decade. immune potential announced Affairs Coherus I'd and first its Regulatory evolving who brings recently, Officer preclinical mid approval, development advancing human be clinical LaVallee, a Development translation the recently XX to potential research product help pipeline and mid-XXXX. our now years has internally where for strategy Medicine experience With Dr. Immunotherapy, first and is we're checkpoint immuno-oncology entering to of and immuno-oncology in toripalimab we Parker diagnostics, IND LaVallee for the her stage advancing drive of team discovery that Cancer early more inhibitors productive. an for recognized and organization. candidates with generated over introduce development nearing immuno-oncology Chief developing company checkpoint Further, successfully and of Our like our MedImmune and Most broad a to stage trials. development Vice at PD immuno-oncology TIGIT-targeted Institute's drug scientific of clinical file of immuno-oncology Dr. towards this AstraZeneca. innovative an novel related

Theresa LaVallee

be commercially, our company innovative gains and immuno- momentum broadening late stage portfolio transition organization in-house but and well clinically as focused successful It oncology, to IO complimentary PD-Xcombination required very in product to positioned and Coherus mid Coherus an development analytics, Coherus with formulation can early, competitive fields. proven oncology believe capabilities. both informat transformation. and the Thank leader. you, highly is a join CO expertise products support has class succeed is Antibody world our to pristine assets Denny. for I exciting the its bioinformatics to in needed has immune-oncology and successful science

XX,XXX into We square ago. California facility at we moved site our two have in that foot years Camarillo,

and develop approval. development clinical the to regulatory On teams that side, gain repeatedly drugs FDA the ability our demonstrated have

product and Board in playing review involved selecting recognized key Advisory Scientific a as TIGIT as industry from than our XX diligence the from due MOAD role selection actively target have Our IO more is assets vetting example well a in for academia Junshi. from candidates PD-X of experts toripalimab

JUPITER-XX which the Case cell strengthen Denny and profile significant survival in indications. survival date overall continues of a is For, showed to across immuno-oncology immunotherapies toripalimab with an XX. low profile by medical safety trials. mentioned squamous that Coherus, these toripalimab, from toripalimab ongoing carcinoma, progression overall and study even under positive review for an free priority BLA The the our in investments survival the asset point efficacy unmet data no is nasal earlier establishing approved in PD-X clinical an esophageal action patients. are excellent with benefit carcinoma, in foundational need paying April the off, clinical pharyngeal FDA

and the the EFCC. submission a of have BLA year We combination chemotherapy for treatment for potential to later line continue will of in engage on first with supplemental this toripalimab FDA for

FDA carcinoma, which type hepatocellular Another Regulatory response Asian important said PD-X. has of Flexibility patients in also new which tumor the of and for immune highly warrant prevalent could is descent,

flowing indications toripalimab We The to two lenvatinib toripalimab. FDA XXX immunotherapy randomizing to including HCC with into An believe provided XXth Initial seeking cancer placebo to FDA wise meeting helpful is early We views. later fully the lung available toripalimab with clinical data sponsors HCC approval therapy for have or understand submission this placebo resection. from and XXX discussing patients decisions for following options. patients in HCC fully cell trial pivotal for front are February clinical line non-small with versus event and lenvatinib are engage BLA year. conducting for PD-X to trial, their insights advanced these ODAC adjuvant we the evaluating expectations trials approximately it expected a approximately studies the a prior plus randomized

to this first cancer. of continuing them non-small with toripalimab combination indications, potential for lung meet the year the FDA with treatment are chemotherapy toripalimab with multiple cell We for for for line we'll discuss frequently in pathway and

Although there die effective patients disease. more treatment cancer, inhibitors rapidly cell of are the checkpoint lung are FDA as still deadly new for majority options and needed this non-small from approved

we cancer JSXXX. the pursue needs. patient toripalimab The focused the are We of addressing first type non-small will lung be on tumor combination with cell unmet for

immunity. TIGIT foundational subset potential the PD-X of cells translational about the A We by into is stemness to how pathways. between a important of been antigen T exhibit and to have emerging Cancer as PD-X the antibody, prematurely. why reactivated are treatments. development an excited I-O, and for attacking anti-tumor decade they PD-Xinhibitors research off checkpoint trick T studying I-O After unique have cells better that field be with crosstalk understands the work, of TIGIT this enhance

strong to cell trials continue have studies now as with has lung setting, for clinical United inhibition prior of with studies, data combination as observed back clinic clinical patients advance as results who cancer. pivotal treatment the news in small A in lung indications in IND demonstrated on solid the later we study negative triple evaluating All line as are clinical activity well to non-small failed in in call also for toripalimab mouse patients hepatocellular preclinical cell planning cell carcinoma. and this for And FDA, well as this Denny. activity models. cancer JSXXX evaluating advanced toripalimab additional Neoadjuvant I’ll specifically Depending EGFR One and US to non-small mutations with of a toripalimab the Clinical is clinical combination in open binding inhibitors preclinical a toripalimab additional the TIGIT year. the affinity these first as with breast come cellular in the and toripalimab in enhanced and with cancer, intrahepatic in with antigen in lead could of studies States. flow excellent combination ongoing. and PD-X and pharyngeal with in in lung the from consistent therapy this two in with turn will tumors JSXXX the The trial United is States. in and studies. conversations carcinoma JSXXX anti-tumor the cancer is monotherapy outcomes improve in pathway TKI trial In JSXXX year

Denny Lanfear

you Theresa. and mid to Thank on late great our you, stage directing It's team development I-O have the efforts.

accomplishments with diversify approved stage portfolio. recent our to our portfolio goal summarize commercial our respect to grow Let and our briefly me commercial And FDA products.

in You our may Paul our in biosimilar. address a this approved launch product December planning for FDA second important the XXXX. recall YUSIMRY, Humira will

which would for sales to for million UDENYCA. forecasted source would that a $XXX the second support in injector funding $XX context in XXXX which segments. good some launches. we year breast, our UDENYCA additional ensure the development continued to approval to important of supplements Net the And decrease to the similarity syringe prefilled and of XX% investments of revenue commercial key relative competitive approved demonstrated growth is to pharmacokinetic it us. wave will with randomized declined BLA. format this in continues project market. launch enabling penetration of are our we the UDENYCA submission We've significant mix. of UDENYCA of provide In a October, UDENYCA has million directly about that on-body fourth we We terms Neulasta, market in UDENYCA pipeline within compete to very to provide reach increasingly to had on-body success XXXX of with net pharmacodynamics and generated net UDENYCA the clinical upcoming presentation If trial, injector prior address tight of in XXXX. all quarter anticipate share segment of the It in only market objects. biosimilar of be revenue Cancer issues presentation considering the Onpro

mid BLA meeting August BLA Lucentis through Our strategy in the and progressing market XXXX cycle is is October is XXXX, to on-body a biosimilar, share and untapped in to balance year. action review, significant the for review the accepted In target share optimize date accessing segments towards then XXXX and well revenues best format recently price long-term FDA the the occurred this in CIMERLI, getting

As will CIMERLI plan Paul launch half we year second in elaborate of to the assuming this approval.

on-body in XXXX. maker growth. revenue by UDENYCA NPC YUSIMRY launches for of diversifying our product accelerating planning should in two the launches toripalimab also followed two launch XXXX These and of are be further We the portfolio injector, and XXXX the in

products inflection line growth point these four to this top year. filling expect starting new for We market revenues, later

toripalimab Reider, we've discussed. expect continue longer JSXXX with to potential project with for the innovative our We turn the CIMERLI Paul in Paul quarter and Paul? growth the pipeline call And term our that toripalimab, and combination to label will YUSIMRY. update review toripalimab fourth growth you I'll Officer. preparation for and expansion launch performance Chief over of now Commercial I-O and UDENYCA’s the

Paul Reider

Thank Denny. you,

progress erosion fourth units, sales and well As X% in intense decline was prior indicated quarter, to net were and the Denny price down surge XX% the previously, a quarter. due million from continued tight pressures UDENYCA This demand competitive driven $XX market. in as the by as

in in non declines both in market the clinic XXXB period which a On quarter, quarter, hospitals. market growth. the were XXXB historically segment Our overall fourth XX.X% modestly share fourth pegfilgrastim market the the offset XX% slightly slight we've by to gains a unit basis, seen and declined declined share from in in

XXXX. which term advantage market. of more We low device continue return overall market expect the XX% to originators broadly, short COVID to Until single a share will favoring there be on recedes growth the digit in to retains approximately body

sales approved. on-body again once year, introduce As UDENYCA our if Denny we UDENYCA grow to injector indicated, expect we next

in the and price significant is on-body long-term accessing segment share the gain strategy optimize in format PFS revenues and Our with XXXX. balance untapped through to market and share XXXX then

brands the or good this NPC tumor to Toripalimab rare for to the FDA. there about type. like talk Toripalimab the be not are According But pipeline, YUSIMRY, or our commercializing the potential three our XX and preparing the and for has line months. our we inhibitor biosimilar by HUMIRA the PD-X carcinoma. new is pharyngeal for nasal to new cancer, has for of only no Lucentis launch PD-X standard inhibitor were pharyngeal first of inhibitor where also a biosimilar. establish in I'd a currently next Now PD-X carcinoma, potential use only indicated toripalimab, nasal first CIMERLI, care.

commercial into capabilities track. launch have that preparations been to integrated and effort be built Commercial toripalimab the commercial as for note scale proceeding existing oncology I'd on launch are to will like our Our infrastructure. efficiently also treatment added significance line guidelines study for the in serves pharyngeal trial. important the a to nasal recently which reference, NCCN the of this validate JUPITER-XX first carcinoma clinical toripalimab the of NPC

positive a allow to competing We've area. with work capabilities. $X.X respect will the account, documented focused action Coherus also the August viable expressed to team, our and similar in FDA our our launch success deliver value Retinal in the to will the a to of the our time the with to biosimilar Now community dynamics market and a leaders with retinal entering to support completed and commercial market our alternative intend plan UDENYCA, quarter. confidence dedicated receptivity set therapeutic of education leveraging Similar ophthalmology safe second and market CIMERLI, with this and give that to key organizations, in patient while and proposition. have account specialist to record a track access at date of them and oncology Lucentis along we launch effective playbook campaign segmentation Coherus in compelling forward in early existing same formation stages we sales market a we we that opinion retina understands into XXXX, market look to the billion launch us this

in XXXX. forward selling we're the has Humira in competing sales been YUSIMRY, net with this Now XX. top look July billion United States we drug preparing $XX market. the of And launch on in the to for in to

While significant competition. expect we

interchangeability delivers and key payers formulation, to national payers least gleaned research and Our The the auto address adalimumab syringe citrate pocket on of injector value patient and deliver to goals peak adoption, are These according biosimilar the high research, to to commercial research not utilization to believe was a that product from in are market. patient and quality non-stinking multiple today will the presentations already their market to they all completed mechanisms that at robust PBMs. and the and on routinely that Coherus to to with product management based can pairs Also, as this manufacturing, prefilled comparable stakeholders, free as costs. achieve reliable, price of high to have comfortable, patients attributes, our essential, and have services with competitive critical that nice drive regarded for facilitate reference gauge access needles insights confirm a that payers formularies overall use have a regional product extensive to include share well expects drive use. since Robust supply, categories. out at reliable tools easy support adalimumab and expectations. as selection XX% We but the and

Coherus to meet guarantees large has compete to expects supply well these price. on previously invested and manufacturing to in expectations, and So scale positioned be

have auto quality syringes injector and prefilled presentations. will We

Our formulation. comparable YUSIMRY our XX also device use uses gauge non-stinking originators. the we proprietary citrate- And free to needle

to our In high today, facilitate and the considered an addition, we affordability. best-in-class, established pegfilgrastim access and have Coherus services patient class one Complete, is are of provider touch for which service and offering

Coherus successfully the minimize within have Some in large will their a competitors a premium products. on branded competing to offering trying adalimumab of portfolio focus contrast, impacts price constraints the to erosion a market. position singular payers. Without price of may portfolio collateral adalimumab by on biosimilar the

results now to best believe I'll we consistent We are is YUSIMRY. patients. this of large of market and become overall in we a share the also seeing the quarter’s our with possible. confident is interest market the compelling and forecasts deliver short, turn review results. expect overall the with in McDavid payers for can Our as interest as value proposition call In adalimumab financial

McDavid Stilwell

you, press The of Paul. release. details Thank results in the our are financial

So I'll focus on highlights. now a few

$XX the and reported respectively For on for XXXX. $XX $XX million in million year the of for and XXXX, fourth a the quarter was activities GAAP we net year losses $XXX and Cash fourth million, quarter used full basis. million, full operating

of Development costs cash to cost payments as XXXX. the also XXXX goods increased and Accordingly, the lower run, improvement lower the was million manufactured million periods revenues reflected compensation the net the simultaneously As the $XXX clinical end. on-body earlier the with an the exploration. and three-way driven or commercialization well year, expenses and the manufacturing UDENYCA XX% general costs. were Sales net $XXX to for well affairs was our we license, upfront were a advance of off is syringe $XX Advisors and toripalimab, year as approval, BLA $XX tranche XX% $XXX X, margins into upon up Wholesaler and as agreement additional for filings $XXX that return million for subsequent significant toripalimab the drew inventory are the year of We of and for an the tranches. well $XXX $XXX in per volumes year, the within trial gross cash development resulting UDENYCA in million loan process draw unit million We notes call, for the million XXXX, million clinical to at XX% the year. term loan, and and tranche equivalents. expenses normal the late at is due administrative as Junshi and entered as credit closing million $XXX $XX royalty for range benefits starting quarter Recall term percentage XXXX, and over and tranches FDA million as detailed inventory higher $XX CHS-XXX, Two to This million unit that as million simultaneously us cost and a as for higher remained quarter that pipeline. will end, for has at such Pharmakon expense decrease reflecting prior injector, a $XX and to toripalimab of quarter regulatory and price. the revenue Avastin manufacturing year. This with Cost come paid Selling, in across the since end expense. the a million PK ended we and YUSIMRY, was includes we April for Activities year first Research prior activities approval of evaluating $XX a ongoing primarily net fully study a realized million biosimilar. acquisition quarter quarter to Recall the the facility pay for for long increase depleted million within off second available for become the gross the convertible and stage stock-based expect $XXX million prefilled for we we a and for CIMERLI. to in first each respectively. payable plan of as a of margins March. in that $XX then four both increase since and scale to of realize to In by UDENYCA

$XX quarter This to pay rights million to Biosciences $XX in stock and XXXX $XXX million. expenses approximately or we first become the on $XX of of compensation range for later $XXX non-cash Not due $XX of for million for to We approval are million guidance upfront guidance JSXXX year payments million includes expected introducing the R&D million to including will milestone in NPC. expense. the Junshi SG&A full -based fee toripalimab

launches. cash to spend new for some will investment IRR. product with additional Let manufacturing will we which convert This on me much these color year, approximately $XX operating anticipated is high of million a quickly that expenses, back provide inventory

low FDA one benefit delivers cost manufacturing to lower expense of a with P&L You'll going in is COGS. launch successful to the ample recall that is from form lesson supply prior UDENYCA that approval recall inventory that our critical and success subsequently market Also factor.

development million next up cost expect operating of will additional over of years, $XX two the of year the scale of introduce manufacturing of that will to expense fund $XX presentations completion the as in this significantly well Another projects deliver of benefits goods. to products ongoing lower million we form as

at front, Finally, conferences, event we turn will present the the also York and we're from Coherus late Barclays the investor closing host and hopefully two the Analyst March Conference. Conference investor March remarks. in Cowen City, Denny New And will in now I for host person. relations in planning meetings the Day to in And call back to

Denny Lanfear

Thanking of with McDavid. I-O company in-house combination A with our commercial Coherus year, year levers proud advancement a the to that the you in initiation now first innovative evaluating clinical The for out and potential an IND, a success laid and stage strategy. vision asset toripalimab preclinical execution in ago, towards that investors promising this our later of fulfill trial team of this in-house the we April, clinical we the ago. of am of our our year told are I-O was we become and TIGIT confident approval I with will of immuno-oncology toripalimab on own pipeline, programs in asset that of are we to my promise the delivering hands. vision novel of

next in months. are side, XX commercial the uniquely products launch positioned we multiple the On to new

total the will opportunity addressable $XX $X.X launches, With these from than about billion increase by to tenfold, product portfolio billion. more market

toripalimab product the through decade. our commercialization. advanced as fund Operator, growing this of And pipeline expand as our are questions. we're for end additional the portfolio will to added. growth This opportunity to continued commercial in will indications ready immuno-oncology immuno-oncology Our candidates continue

Operator

[Operator And Salim Instructions] of first question Syed comes Mizuho. the our with from line

Salim Syed

one couple color. me Thanks for the guys. toripalimab. much for I afternoon, can, Good Hey, so A if on

lung understand the would long prospects and uptake as little to an a you a question of bit versus Medicare be in head approval, and think guidance of prospects and on be toripalimab off reimbursement how would like And in the need allocated category NCC medication ‘XX. subsequent additional costs getting lung? to late in listed second post trial April, assumed the I Or PD-X on a the a really then to head about those shared? or you'll for label the specifically, here more strategy UDENYCA is So NPC that's guidelines do

will roughly ASP be -- how in about ’XX, I had that ASP it's a to XX% declined. by thinking you So about Denny, my lower XX% lower revenues are be XXXX, ‘XX. appreciate going to than But than math declined

this should is we now largely declining, post ‘XX, year COVID fourth market. and moderating So cases Prestel, thinking and also launch, the about with XX% of pegfilgrastim that the be On then of having in here

much. your thanks Just could you speak views qualitative here, on about please, maybe units, so

Denny Lanfear

answered, Thank you for then that, not ask then Salim. can your I and we're happy we work on question, themselves question would to so to is go one that follow questions if limit through through.

answer posed So Theresa, do LaVallee. of let me you to you direct to one? that want the that question the strategy non-small regulatory Dr. cell

Theresa LaVallee

NPC continue the Denny, since forward question. non-small cancer, discussing haven't Thanks, mean, to path the ODAC. we And the the data, cell I given be the between had and is cell for of reviewing meetings impressed to the of any with and cancer. lung for and FDA with tone the lung gain thanks overall kind the some I indication forward how think FDA look data. And them, for non-small Yes. the with

So have them with on is often and packages. conversations our to the frequent aligned and strategy

Denny Lanfear

endpoints question. to aspects Any comment the our to with study Theresa. you, additional or Salim’s respect of Thank other

Theresa LaVallee

designed meet that FDA statistical finally. endpoints secondary endpoint was and which the of survival pre-specified to part the are a plan, we for was analysis And was overall have

Denny Lanfear

Thank for rest any additional of what of for color sales this sales. Salim, you Salim year? think the I that. Thank the your you. through on XXXX Paul, year UDENYCA question, was can for second second you half And with to respect we offer see

Paul Reider

Yes, question, Salim. Yes. thanks for your

becoming to And continued I as in look at declines been over throughout competitive. I we've it's ASPs, this you increasingly our three if it's expect quarters. mid-single averaging think So, market think price last reasonable digits XXXX, the

with within the we're on-body on Our of to after revenues and of XX% for look share, go go XXXX, UDENYCA market if prefilled persistence context strategy as But the in in of be approved, of it's the balance for the optimize through been ready I COVID. an to syringe to to think market to we to be remaining segment. entrench able that's, the really XXXX, device going just been has longer-term pro to launch that, price going itself

we're what that's thinking. So

Denny Lanfear

answers loop hope to We'll question, little Salim. you your Operator, to with can we that have have more I happy that next that. if we follow question? a be on back

Operator

next our to move Company. question, We'll and is which with Cowen Georgi Yordanov

Georgi Yordanov

taking questions. you Thank We're for so limit much going to guys. one. our Hey, to

to on recently how TIGIT announced in differentiated talk from advanced there? could these later out the for the So are with monotherapies? you run you us maybe of and the here Could that [Indiscernible] you're you in that the the combination expected remind percentage what trials development for R&D partnership of asset, of antibodies stages mentioned that with then And TIGIT more being intentions costs about development US in your responsible for? associated that

Denny Lanfear

for part with describe to around the I'll for million let respect is cost. me $XX you Now may which our in agreement year is respect one. the Theresa is limits Junshi TIGIT toripalimab then last the take costs And TIGIT. products, costs, per let to it the of per first same that opted with share strategy our the That JSXXX product. clinical as to With recall

the to those under of we that auspices caps. this and presume done committee subject steering will joint the the partnership So be above

that, we opportunity not partnership. additional may that additional some And into if paid Now to that for is back the do, of things there's later. be to has the that then Junshi to opt outside want work data that

this asset, potential this partnership. assume joint that on primarily will to markets, probably few the With however, through and across a be safe like to TIGIT comments globally, you going respect our strategy alone, will developed developed that of it's committee internationally, of would make the steering Theresa, to all Given be differentiation, that? development, into

Theresa LaVallee

the has models. where understand with we antibody cancer, from cell types, non-small develop to it Junshi such a I urgency. and obviously see activity in proof with significant tumor with we've potency to to not it seen our Yes, it translational strategy and of as partner on think activity is And advance in we lung really preclinical the combination TIGIT establish in toripalimab data to principle look

Denny Lanfear

any ready with be single have the formulated co respect which Operator, the we next approaches for and as provide have other caller. the you vial. product, to Do additional developed we're color would TIGIT, to

Operator

our question the from next with comes Schott of Chris line And JPMorgan.

Chris Schott

nonstarter Great. meet Thanks my But how FDA. the you of question asking contract lung how required biosimilar to toripalimab debate back and been biosimilars makes is here that going payer something coming if Coherus going much be or to you slip about know to about? US FDA one they're for, non-small was the that's this And there's And need cover. many you still what study of run or a able a I think lot core not? to in based back for sense earlier. that questions Would come Humira. to going is half I'm volume so to a it each and much. that cell cancer, up and a with as is to head-to-head if kind discussion

lot biosimilar of you focus expect you expect and volume to or in of biosimilars be retain So of can the two out going biosimilars, it's that be the a there's you do look more is you how going do XXXX you out on payers one as a jump plays to bit to when and do it's in elaborate little so execution? where market? you expect multiple ABI this players? Do about like that a the a of kind to think much. commercial a Thanks to sizable you is Or situation on the and think Or that it's just to available kind space beyond? going portion expect

Denny Lanfear

three a for think half, your you of one one the at questions I Thank okay. Chris, but quarters and there, that's

Let address YUSIMRY, about and Paul first then similar back move question to Paul? toripalimab. the you for on HUMIRA we'll

Paul Reider

thanks your for Yes, question.

time. time factors in differentiator. we non-stink entering price, another my And of of substantial be to the at at injector same be we'll launch those time The So, auto biosimilars at that our proposition, that of July all prepared will types very citrate-free be prepared of value and I formulation prefilled presentations. syringe a remarks, supply, includes mentioned and of competitive guarantees, in one expect XXXX, do to what that the bring, to the is a will market number

slower over not covered their launch, rapid YUSIMRY, And from term be of happen payer it'll or short of away innovator, might in of the single think proposition them time plus which plans, providers their level the particular and in and the value of we'll is a value proposition at on to mid-year, look that biosimilar deliver based do a way, case, high a be lives needs. a their expect that all, be we conversion volume, either objectives compelling to will transition so the businesses. And one fit into as commercialization through upon portfolio time, the plan control the I to will depending but we all, have very well. the our going what meet And to cost one at to we the segmentation expect is, their of size expect most a HUMIRA low their we're fits

Denny Lanfear

have with point competitors the think we other tremendous I of wouldn't percent market it And The we years around. a with going did to share. three a would or make there's to market, surprised two if the all the majority to as of opposed ahead relatively be greater Chris, number cost be market, that share pressure in be, respect not of that, small as had

FDA, to very the indications, a that, the number haven't lung. convinced our and idea XX% high it's, FDA, in share type Theresa that a respect probably they're of a With conversations, interact on for as post doing the forward believe XX%, of any us regulatory the that and not we with to have chance ODAC. that across we efficacy we safety including to to think preempt had question prudent molecule said, have line, And potential your down probably pathway, really we we we significant toripalimab with just look are So we it's gain. demonstrating to quality

though, talked think the what very about about require types on were planning lung of probably with we to remarks. about be prudent you'll her enthusiastic talking So going hearing the and sort of into we're in in That course, more it's they of prepared things. to FDA we with conjunction about what in end moving move of when toripalimab not asset the to might towards that really and said are that, and being how TIGIT that. studies talk and But Theresa, later of year. we this

that tuned one. stay So on

Operator

Prasad Barclays. from And Balaji line comes the with question our next of

Balaji Prasad

good Hi, you. everyone. evening, Thank

biosimilar your prioritize you only two, multiple one Humira, also of firstly, do on trials, with trials, non-stink are kind you better So million the cash, next on quantify with if that and Thank and your year? citrate-free market advance formulation can to just the provides top with back ones the to to formulation can citrate-free what One, and in getting probably going $XXX advantage two if need quantify be also clinical be And to importantly, the clinical or next it would what trials going you to you. expect the year? you? you

Denny Lanfear

Thank you, Balaji.

anecdotal injection, not the does of low citrate. of formulation uncomfortable. issue address because And comfort it's Let very ABI patients that it important the of formulation. me found very the that the viewpoint patient formulation unduly previous concentration that not upon have does stink there's data the from first It's uncomfortable

the So citrate non-stink developed free formulation. proprietary was we HUMIRA several years ago when which XXXX at biosimilar a we approached that time,

important markets to I speak and think this won't able from Paus is penetrate the but the patient comfort said. I as and Now for very, viewpoint others, very being

market our think, as that very and spent go. that's but in advantage to the for supply guaranteed expense an we of such And in supply it. trials think well formula we prior of served the And able do has we made some IRR. to market team UDENYCA do And excess market. think were that in to that that recall, one achieved million and manufacturing hand, for however, Now costs, while remarks, example, the pays to where be the very that's others very be may us and on stockpile manufacturing, you clinical his one million other now, gone And answers , we same for launch, and the or post ways we to have able indicated that scale, that with there was are that. as when share parts very, to, various of well at for as later call that that applies matters, want on of significant launch, there's to We did were significant that significant why it’s think but that in $XX significant was price it XX% we very did a to XXXX, large will wide with $XX that But we succeeded and in example, we have McDavid fierce we’ve think in so. the reasons syringes goes and at pointed able into in respect expense to I the not be out spends back we and that prepared, those to we I gives investments. COGS question. Humira, the here, think competition McDavid with inventory we your you I guarantees, Hope market, that XXX,XXX

Operator

of question America. next of the Our comes with from Gerberry Bank Jason line

Jason Gerberry

He, line I swing first hard it it guys. first you was with expected PFS seems patients if Mine you're second my combination much, much population? Can used addressable? XX-months is question. Thanks How factor second line. bit for these chemo a you second about pretty therapy? on line, line, expectations because be patients talk interim I like verse small And be it was really US first line think to a this, the are more here it's mono little to many pretty like the going taking to NPC your the think these Is market of opportunity. line or But there's with big for in a shorter. find

key just sense to kind an parameters of So forecast. frame you trying of can the of a get oncology

Denny Lanfear

and market so in size I’ll Thanks to that, the for of rest with on. respect on get as expect line the your first Paul? course, fill to we Paul question with of question the NPC.

Paul Reider

Thanks your for Jason. question,

cancer, third data a with setting. there's that cycled a And are a in patients thousand the those it's first through of suggests patients, the annually. yes, NPC So rare couple treated line about

first there's patient treated see up that on. data base. you're over and potential to establish PD-X with as we so therapy chemotherapy got pick we them, anti-body to in have only to believe be them really only a to plus we've that's with get we Yes, later for combination significant first patients of and the the of of expect PD-X patients, including for standard NPC, progress. and the with overlap got line current standard in the our care want NPC, we then of these line, Jason. of first that the patients approved not with And line. we lines if so later expect, first it's care going we'll first a But of new looking will, they using toripalimab and And X,XXX volume, half But, HCPs, we've line, likely at for approved our about treated be chemotherapy kind new will are to they're data account lot in the data where

XXXX. we'll very of so launch story voice it, the to NCCN guidelines widely A at Medicine now there has been NPC fact the Nature here. presented provides for going high tailwind the data was is of last drive that share in launch overlap Plenary in real toripalimab and of time ASCO And year. synergistic into And the course, us a potential in by study published added already

Denny Lanfear

thing here, also will course, other the second and add third Jason, I line. we of could get

our to under pursue Plenary going Paul very think a session get Nature a and the holistically. we we case and And we we market months. have After indicated, into so Medicine the therapeutically ASCO approval the through we're get so forth. quite And belts few strong with and as MPC

on, respect with forecasts be to happy we'll back your loop think so fair to and is I question game to.

Jason Gerberry

setting. only PFS me was thousands third a couple basically, remind you third treated what thousand them line, point first or get second through just make a only of line the of so and one you to it Can line line, couple that ultimately the the first the a in third cycle in first setting a was say of

Denny Lanfear

cover you do that one? to want Theresa,

Theresa LaVallee

was XX.X a PFS and XX%. Yes, months of year PFS the line with one first

Paul Reider

then setting. annually patients a line and get the treated first treated Jason about third couple thousands Yes, in

Operator

Wainwright. line the H.C. comes Douglas next from Tsao with of Our question

Douglas Tsao

Now internal added of I'm sort curious. just R&D capabilities, your I-O. and own discovery

Paul Reider

Doug. Forgive me,

I we part the restart. think of missed your first question, you could

Douglas Tsao

yes, Oh, sorry.

a you see be own you versus And assets cash your of about own you're sort launching Thank M&A in curious, capabilities, started sort business development? flow now Do add going business it sounds. you you. be your flow internal your in, on quite internally and discovery more I-O, sort You've Obviously, significant. versus effort potentially bias sort now you aggressively? your for the you developed development just ones how have comes I'm want as do think And acquire? of of to should growing as a cash business focusing number vision towards products, of the that do might to of

Denny Lanfear

to be And we time a out directly, about the our of Theresa approach of with great the open preclinical, example, with It's important early assets. have late mid development TIGIT, answer time have But toripalimab bit us of There's to stage, stages lot certainly us with Representative number three toripalimab. the And opportunities portfolio development, chase we that by, of a all a question, efforts. little combinations. various to stage approval stage That's from opportunities question that's central we across talk folks and of development who business development, there. Doug. balanced for early development, a TIGIT then for I-O. to stage your I'll let cut course, very this would

our anything few them. a Theresa, We haven't But early to want locked far. in we to you continue look about say so pipeline? do at things stage

Theresa LaVallee

important me to really molecule, that Yes, to one Cell to But PD-X, it's well then TIGIT science the the tumor was, on activated with T we T me way about attracted is so and microenvironment have going the in an targeting get early no, joined, important immunity. cells the talent. that broadly and microenvironment things the was toripalimab and and if at addition how the you aspects recently the is field an great the suppress and the surprised aspects have and after the think strong together the and T what the as excellent preclinical active people hindered. anti-tumor really that in starting really And have coming was a having to think looking put how having Coherus and and of assets, of I really pipeline, cell,

it's I year looking I'm to think as IND exciting. we portfolio stages, going the trial. getting in-house it I was clinical looking be mean, at starting next the forward that advance and an really And in-house to So

Denny Lanfear

our further in-house bit The further comment in investor of more working New interesting. Doug, I as conference and And assets quite a I offer at you'll think other York. showing it March some will key is in I on time. our remarks. a like I around detail find that indicates any think the for few we're to doing, personnel McDavid we'll would no you, of covering the questions this over explain end mechanism this back And be so were would out at meeting action, the around turn Denny Thank we And of bring I'm to Lanfear that things you. the

Denny Lanfear

end upcoming of more quarter Cowen detail call. look today Investor Day to seeing thank year also conferences talking and fourth joining end you Thank you for Thank forth. at want the in you. of for event to you to And at you. We our we forward us the in conference We forward our so look to in all March.

Operator

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

disconnect. may now You

Coherus BioSciences (CHRS) 18 Feb 222021 Q4 Earnings call transcript