CHRS - Earnings call transcript Q2 2022 | Coherus BioSciences, Inc.

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Q2 2022 Coherus BioSciences, Inc. Earnings Conference Call. [Operator Instructions] I would now like to turn the call over to Marek. Please go ahead.

Marek Ciszewski

Thank you, Mandeep. thank joining and everyone, afternoon, you us. for Good earlier financial XXXX. results issued a the our release press of We for announcing second quarter This our on is release found BioSciences can and website the also X-K. Form Coherus to attached be Today’s about events. call expectations future includes regarding current statements forward-looking Coherus’ projections, multiple sales SG&A include, not to growth market our our profitability, projected our about candidates products share, launch achieve and our R&D statements our ability expense projected ability our ability and our limited revenue These line products, our top to, our opportunities projections to XXXX launch and time line. our guidance, but market to are new to generate product sufficient according and advance to successfully uncertainties could differ by control that are forward-looking these achievements performance All beyond cause achievements to results, and and performance from or results, forward-looking statements. implied or statements involve the risks actual our substantial of substantial press that and documents second are performance are in the with statements future that that we we to we on release that discussed today. not are filed well issued report including XX-Q today Form file subject as These our those SEC, as quarter for uncertainties the guarantees in and the risks quarterly our

call Chief Officer; are Chief and Officer; Financial Denny Forward-looking update Reider, undertake today’s Dias, this no With Lanfear, Stilwell, statements or statements. Paul made duty CEO Rosh Coherus; Commercial revise call provided are Officer. on date, Chief the on McDavid today me to of of as and we Dr. any Medical forward-looking

now to to LaVallee, is turn join will is I Our traveling Chief on unable Theresa over Development the Denny. call and Officer, us. Dr. vacation

Denny Lanfear

recent for Thank good afternoon, you to conference joining financial QX results you, and call highlights for Thank and business our XXXX. everyone. Marek, review

to Coherus an exciting our respect pleased growing entered products. to diversified revenues third has The into profitability. transform strategy. into executed company let which expect make report products, XX-month on is CIMERLI, of innovative continued strong to about leads true to particularly our We’ve with an portfolio by from will a now few to resulting a launch Coherus period, multiple execution team where today I’m we me product. immuno-oncology approved in back which progress revenues, ultimately First, remarks well driven

As dosage the you differentiated means competitors. know, earlier designation as or with our markets. Officer, Reider, our as leverage The and year CIMERLI of approved year, and market this it The designation. moment. opportunity for other because interchangeability strength UDENYCA important also an biosimilar that regulatory for Lucentis biosimilar demonstrated will Paul you do included will with in potential later level. recently interchangeability the will so more, with Lucentis the is a a launch in two has and biosimilar we announced the both XX not dosage significantly FDA for only competitors our exclusivity strength one at Lucentis Furthermore, limited complete relative Lucentis a we does expected interchangeability week, have and approved are elaborate delays approval biosimilar not label and label seen buy-and-bill just and improved to launch old months. this strengths formation commercial of and Chief the other one when This to The Commercial

CIMERLI we that and all with For do well we confidence these believe reasons, very justified. our will is

across characterized team rapidly is the less that XXXX board. PD-X was readily the and XXXX. strong straightforward execution nasopharyngeal at as identified the this both two a has December responded we of new manufacturing very stellar track that due and inhibitor indicates time by which focused into approved. in Together, launch our back XX, to we expect fair Junshi April BLA our characterization alongside the toripalimab, to regulatory teams, FDA than our to if And candidate, PDUFA product the affairs, issues toripalimab partner, The letter, time is Biosciences. addressable. early and execution the response fourth assigned our FDA’s XX in Our a resubmitted on quality Having date months’ on complete working highly carcinoma we

strategy immuno-oncology U.S. co-development arrangements immunotherapy to evaluating cancer includes toripalimab’s benefits clinical Our ability designed the or and other drugs utilization. in combination and other drive deliver significant indications to in through substantial with treatments

PD-X toripalimab development. combinations establish Dias, our In combinations moment, objective choice immuno-oncology a as programs. preclinical a Medical company’s clinical Coherus to in advancing is of Chief we’re Officer, detail a and multiple Dr. for Our internal for Rosh partner their seeking will

while While focused we inflection, tightly reducing on are product and period possible. and structure our portfolio top whenever growth product entered of costs the revenue the remain expense we – have we entered have line

toripalimab, support guidance the continued line Those financial XXXX going year. strong company our and Chief $XXX quarter the additional provide forward launches. Financial to into end an top moment. Day event nondilutive now. access a earlier execution this capital of and With Officer, results and at in We McDavid post $X.X Our CIMERLI Stilwell, at structure reiterate projections some our strong Analyst billion is an to you color in place, across million in on approval Mr. million position $X.X $XXX our billion launches of a will this just in provided the cash additional financial in operational company efficient

Well BLA as ultimately well [indiscernible] that I’ll turn Dr. multiple direction, anticipated Dias, confident are next over with the certainly way an to call and profitability. the toripalimab with we earlier, our our are now product portfolio and you planned. long product in who programs. new consistent will update on as diversification months review revenue provide launches to the development the our the mentioned I growth drive we will on capitalized back deliver We plans other us have our Rosh? and for to XX and

Rosh Dias

Thanks much, good and very Denny, everyone. afternoon,

of and nasopharyngeal target the Denny date for assigned referenced resubmitted BLA new as carcinoma a So toripalimab action accepted our XX. FDA has for December

currently carcinoma, the quality to ensure in data the we treatments. at requests resubmission been received an met that there readily time that characterized the FDA their restrictions critical pandemic unmet related would as FDA-approved resubmission the of to you the medical have indicated have addressable. six inspections the in the by for with understanding for existing If our review quickly that given, of completed that have of time are aggressive needs June. they The required no process is months April line In be we on-site of straightforward would late communicated as, hindered our the resubmission as And with toripalimab CRL agency China. course, the and supportive BLA travel the conversations change you the immunotherapy recall, toripalimab patients course, the late repeatedly we for which in BLA FDA, nasopharyngeal are with the which, clinical know, address need cancer COVID-XX and

work novel months, a the monotherapy multiregional and the trial continuing immunotherapy clinical we also demonstrate program responsive we’re at the to partnership to Biosciences will closely variety advance in of the this while tumors Toripalimab combination opportunities Junshi of continues review and studies Junshi with over of to looking with data chemotherapy. to next FDA So several both for facilitate in prioritize immunologically time, robust the novel combinations. also same at agent. with to clinical And clinical work

the treatment With the mind, evaluating tumor for also ongoing immunotherapy and out expect a the this in X an year. our the event an survival expected the patients, results extend dual And and we dual for cell March, in TIGIT As create in a clinical we we’re is planning IND CHS-XXX of the leveraging cohorts be to toripalimab enrolling U.S., in enhance robust of to efficacy lung and Blockade that in with of CHS-XXX early resistance. our to CHOICE-XX care is that new very TIGIT read of develop Day or currently toripalimab overcoming PD-X reported underlying we I/O potential China either believe being combination detailed next U.S. open and at in And standard with begin trial a is with may to later cancer, non-small to currently Phase TIGIT conducted multiple types. next crucial approach study. year pathway PD-X year. mechanism efficacy for PD-X of Analyst

Commercial see In to I’ll Southern programs in competing California. important new Officer, our least several ILTX the and clinical in months, direction TIGIT coming the to these development expect year, to Camarillo we also, first expect IND turn developed forward. to Chief call Paul? of an targeting our are the that, in data And CHS-XXX other CHS-XXXX, the With targeting center by of programs IND data research CCRX one We’ve addition, program. fully future and going the course file at these now and owned of this over Coherus next for submit several do year that Paul we year being inform may our introduced Reider. per at scientists ILTX

Paul Reider

you, good Thank afternoon, Rosh, and everyone.

an prestigious over oncology has business the of I billion of has the $X over product where growing from year. in of both in has Strategic decade, is exclusive in therapies she launches. a and the key earlier joined executive Karen announce an member branded inductee product leadership following and the to biosimilar retirement Coherus Fame. Karen that Pfizer’s Before launching with Karen success of is recently most pleased America Chris who and new new review track proven of experienced Oncology Kotz portfolio, and sales $X of a sales Sales as record highlights Vice executive oncology for dozen responsible as North and served Thompson I’m revenue. Accounts, last Executive President billion Pfizer for to Hall under our of our worked the this a She a

Head have of over launches our and are her the the as We product next to planned year. multiple new leading thrilled Sales

low XX%, quarter segment. second decline units start maximizing sales growth trade-offs long-term with XXXB overall QX, in by in the positive in performance UDENYCA Overall over our the UDENYCA. with prior the balancing share strategy quarter, of the quarter. price share second demand share XXXB this Market a equivalent similar were in the Hospital reflects competitive were the X% to with of Net occurring of stabilized let quarter losses offsetting $XX market. Now prior second revenues remains execution by was in the based entire me and has been quarter the intense in increased declines the UDENYCA to million X%, the which on clinic margin by the margin. continued price trends. we continued class an declined retains price and And pandemic due remainder single-digit customers, reinforced X% of XX% basis, reflecting share market XXXX, preference the total which Onpro syringe XX% the discounting consistent device and by historical market in market is originator. overall selling Neulasta owning within with pegfilgrastim share, the Net over entrenched COVID On the a to price pressures unit segment. expect erosion for low competitive Hospital QX. growth prefilled of market in

in to share gains us the we the opportunity. the pipeline, This format revenues $X with is On-Body UDENYCA approach in billion Our through will and disciplined which longer-term maximize price on-body represents approximately significant a currently maintain managing in strategy beyond untapped injector within franchise the enable prefilled XXXX to XXXX. our syringe that expect segment, to in

UDENYCA to next UDENYCA once injector market We our year on-body expect share if we grow approved. introduce

Now exciting pipeline. talk about very commercializing to our I’d like

August approval the We Lucentis With are Humira was NPC; respect for toripalimab, FDA preparing enabling biosimilar; next on launch in to CIMERLI, inhibitor brands of new our our PD-X CIMERLI, granted biosimilar. XX the commercial YUSIMRY, launch. months: and our X, for three

market. biosimilar occur launch in successful early is factors. we early executing formation have and proceeding in first a to track, billion October. launch confident number anti-VEGF have of of Commercial periods We We the sale $X CIMERLI on on based planning market highly to remain plan of

retinal our dedicated experience we sales of our of whom all capabilities. First, a to Since have last specialists. retinal commercial team, years hired call, selling

the support existing key launch, teams built our full-service and will field meet will both be and care comprehensive And support cost reimbursement enabling patients. of needs to account, program backed the patient launch and providers efficiencies. a synergies Our by

launched and compared designated label to first Lucentis only is the Lucentis The other of five profile all fully interchangeable is with biosimilar recently FDA CIMERLI’s second the as clinical differentiated biosimilar. factor by FDA-approved CIMERLI and indications.

high opportunity interchangeability into of for clinical demonstrated access exclusivity. comparable to to And confidence trial economics, Lucentis currently and of safety We last of These published receiving newly as received a equivalence combined degree immunogenicity with prescribe a patients depending upon an and in practice use any months for diagnosed XX Avastin profile. CIMERLI give our expand well the retinal research CIMERLI confirms new exists to peer-reviewed Ophthalmology patients will COLUMBUS-AMD and was and year head-to-head market CIMERLI Lucentis the that indication. as Eylea. journal The with also specialists

with and and competency the and alternative a gives is effective by commercial dynamics to which core launch oncology the confidence them compelling success. proposition. model, our backed competing of a in a the of that understanding in experience. of is The the $X.X our ours the to UDENYCA, track and record safe sales record And a retinal is buy-and-bill opinion similar retinal with we claim-based, of buy-and-bill In deep in and market net of biosimilar our our which with in success deliver retinal a billion delivered express market. its Coherus Lucentis This success understands Coherus to of positive only biosimilar Coherus and specialists third that will commercial company factor oncology XXXX. value track track Today, record market U.S. market leaders short, is launch entering this has since very receptivity

to Now would approved, plans be, the the if inhibitor now patients bring oncologists and potential carcinoma first rare inhibitors. therapy, care regarding focused toripalimab. to the exists a a FDA-approved toward therapies, which what excited there and and standard of indicated to action are first-line. December Commercial is PD-X checkpoint of and And in only date NPC FDA need about including no we in are XX. launch lines unmet for high of new establish nasopharyngeal currently are cancer all including

incurring built significant UDENYCA between commercial and into of been integrated there toripalimab will Therefore, is scale, overlap have and prescribers. toripalimab-targeted our our infrastructure. capabilities launch commercial customers be efficiently the existing oncology Our oncology to

the trained. citation trial, which the year, the the track, validating on published for addition, and remain In of NPC teams and launch have importance NCCN reference field-facing for as has Commercial Guidelines data. the Nature a the clinical Medicine Committee fully was quality added JUPITER-XX guidelines in the further to toripalimab preparations last been

approved ready by launch to if toripalimab be will We FDA.

Now regarding biosimilar. Humira YUSIMRY, a

believe which U.S. YUSIMRY recall, market in large to payers adoption insights and last you extensive XXXX, research syringe YUSIMRY delivered attributes proprietary, auto-injector launch forward we FDA for from was deliver reliable Coherus auto-injector sales formulation. confirms $XX launch our and citrate-free biosimilar look that regional well important an and nonstinging competitive this and the will December, were net approved in include and price, market. as this have both national a needle a drive have Humira’s PBMs. were and most will highly market citrate-free XXXX. a formulation by payers by XX-gauge adalimumab prefilled can presentation an If supply claimed to originators. robust preparing research nonstinging in we presentation billion as competing We the with The completed with PBMs on has a and to at payers, that comparable and July

has share well post guarantees We launch. expectations concentration low-cost peak, XX% plan a presentation large-scale compete market on high least positioned Coherus $XX unit million in be to a price. introduce manufacturing high-volume, To expects at more achieve invested manufacturer, and to supply and to our also to meet than

overall Our of first-year about exceeds we manufacturing triple current in the And X or capacity capacity XX% market. potential units million to the have that the facility.

some protect have unlike market that of cannibalization. we no branded adalimumab Now alternatives other to to from we need portfolio Humira participants,

this XX% market product that the for will to McDavid, the selection call as proposition seek payers competitive I’ll see a market of that adalimumab as will is are And compelling now to short, and we as that PBMs. the in source objective possible the as at We we financial and achieve advantage. both large unit possible. it’s decision strategy win well who in alignment we as can peak. quickly of share YUSIMRY to biosimilar the In turn aligned Our makers we our least value a that deliver results. review quarter’s confident make

McDavid Stilwell

the the this XX-Q Paul. press you, X-K Thank release, filed afternoon. of and the are in our financial The details that we results

a focus So highlights. I’ll few on just today

$XX.X and GAAP or of quarter loss XXXX. a per million in For the to recent non-GAAP net of XXXX. expense $XX.X in a reported quarter operating or press stock-based our quarter of $X.XX XXXX, share loss basis, is The share million release. of the for to million million contained loss a second non-GAAP GAAP $XX.X net a On share. net per included the in compared second reported used $XX basis of on second in quarter $XX.X per from we compensation $X.XX reconciliation was activities $X.XX or we noncash in the million Cash a

$XX.X due with the an million UDENYCA the Clinic par price. by in well $XX.X quarter realized quarter revenue As was prior lower partially securities Research year-end $XX.X development on to $XXX.X price. second costs XXXX. marketable in is toripalimab, period of including by balance investments Paul offset earlier ended product in million and as units with The expenses launches and development We presentation were The of compared same we period a at for and several three the $XXX.X quarter decline call, administrative the to and million net cash, commercialization June to expense. injector UDENYCA segment the expense and clinical by compared the same increase demand prepare revenues Selling, XXXX, million compared the $XX.X the partially $XX.X in million cash was the as realized for higher reported of as in driven compared multiple million The in ended to current sales were completed general June anticipated support of months to to a driven was XXXX primarily by expense million, detailed to XXXX, $XX.X for XXXX. in in XX, on-body months the in XX, studies for offset UDENYCA. sold and XXXX, new lower equivalents compensation in net YUSIMRY increase lower was million ended three demand XXXX, in lower decrease XXXX. and net XXXX was CIMERLI, the higher

now we CIMERLI approval facility under the to conditions, of credit can request Pharmakon With with certain $XX and subject advisers. million additional an our

available expenses And million range tranche are SG&A to of our the today, $XXX range $XXX previously of will scale-up R&D guidance for with combined approval million XXXX to Another with and million range accounting we now million $XXX guidance toripalimab. will $XX expenses from to a become reflects reducing a in which auto-injector production, and YUSIMRY accordance reduction R&D The relevant be revised million $XXX associated into of instead today. in manufacturing a rules. capitalized upon inventory

noncash Our excludes both milestone Biosciences Junshi guidance million toripalimab range This for expense. of NPC. to will approximately fee R&D payment upfront to we and SG&A due rights and $XX to million the paid upon for in that CHS-XXX the $XX stock-based $XX also million $XX compensation approval expense million the includes become

run reduce head reviewing We have on Coherus always costs. programs, vendors additional to continuously we to And count operating are processes, efficiency. focus for opportunities and

have multiple expenses XX operating we With cash revenues we to increasing over believe for are new execute expected now on to current the inflection additional closing product while request we our products that our biotech launch new only in next product the an prepare liquidity months, revenues, As XXXX modestly will in project XXXX. the markets. equity facility to turn and strength hand, rise call investments I’ll credit and back turbulent our despite we financial R&D to remarks. Denny our continue to launches and we

Denny Lanfear

Thank entering product initiated XXXX. team our plans portfolio you, the outstanding we as a expansion execution back on as that by to and Due is diversification. growth revenue well McDavid. in rapid Coherus

Operator, candidates have to and preparing which we review, growth With new growth, XXXX products the approved for stage cash product pipeline equivalents, financial the believe we’re invest capital the of FDA in resources take projected and will X through revenue $XXX these to CIMERLI, continuing opportunities. now with the ready we questions. additional company approval in existing cash final to judiciously profitability. return sales, products products three XXXX have agreements in FDA to and of we and launch revenue generating million the new of access four in the With oncology to significant to support while launch and

Operator

[Operator and the Ken of Instructions] Our from Cowen first Company. question Cacciatore line comes from

Ken Cacciatore

payer-driven of of your didn’t much. did what market. saying approval there’s major a talk nicely in bit should Denny, it they us could as Thanks been but about not you kind we but I hand. this talk with react, big CIMERLI, really all UDENYCA a difficult, that it be more launches anything And complexities so to the is like momentum than just specialists, heavily be in strikes retinal change, product to have a straightforward navigated. life. this easy know you shares feels now And least being even me. I’m at are when little it a The the

to see detail also, maybe a the than why can you of other ability pricing ahead payers approval Humira, reason and But you’ll about others on think into the actual on wanting now here? to all more get early discussion kind early. talk opportunity the just launch? products much. bit well maybe that your of secondly, can’t Humira around just so Maybe insight then Thanks are available. the negotiations begin of any win So kind can’t win? of the to little I the And have you

Denny Lanfear

you have really very the advance directions sort ideal the the you, This time. a and let right think divisional I that road your both entering big we the that we Below expanding think thank make second we’ve down remarks. products. center Commercial part And and on. much Above – products. well I’ll thank and much, of VEGF market, the this Well, Officer, Lucentis Eylea will other But of Sure. before, Ken, which Paul now observations my market, very strategy. entering been very Chief ideal. the consider course, Reider, a in of in part you we be is have, reformulation did in it, you market you and on is are some of

the further, though, data that be with to there FDA actually, the strong just With was say biosimilar and And I’d Paul team complete the with got and product. very because agent formation and package was thrilled this very to the out at with interchangeability get the proven the to various providers doses marks reason payers product one data to a additional interchangeability interchangeability the to and and market with analytical that. We’re CIMERLI. very, of exclusivity the compelling YUSIMRY, respect on. the in on let and the Humira clinical so having a the I’ll biosimilar interactions add

I think that invested it would And that formulation. payers. was million very clear biggest to trade X high us so tanks, early to in ago, years on these is the important capacity, as $XX feed late what as be we field the

a significant with wouldn’t there do formation small made Being knew and needle. went I So of ahead inventory. And that. what at investments we be We market those to that. would amount important say a

about So off few put we we do But insights and make these on little remarks ground with we a when a can on of well team quite you on going think some that we’re I’ll expect. what to Paul, Paul let next the Ken the CIMERLI, that, so give color? gun market, goes July. more and

Paul Reider

sure. Yes, thanks your for Ken, question.

the well with want the clinical that’s they now, freedom national, as with for as plans sort to – engagement And we’re with is, to got look, them. team want now payers. the with make able the patients. around battle Your focused segment. payer want choice the be dedicated a And approval what I the got conversations best retinal they PBMs occurring question substantial We’ve regional the think was specialists of payer tested relationships all

how so really And going our be we’re to going overall that’s to align strategy.

to stakeholders. value we’re all product And a be compelling. Denny to going As differentiated got mentioned, to compelling a that’s deliver very very going proposition we’ve

to frankly, will specialists, as come And because, multiple in designation excited and interchangeability comes And label, going differentiating want talking to we’re when payers similar dosage all the is we’re CIMERLI full products. here. and they to exclusivity the stock one the retinal think the interchangeability with to the biosimilar yet designation. product, quite want So that’s And it another we provide that’s be. strengths use going component the got they’re to to ranibizumab where

market. about we’re into this So excited coming really

as about regarding a commercial to closer Now talking the to in more be price, get launch we coming price weeks. we’re little going bit

stay So on tuned that.

Denny Lanfear

offer just two remarks. would Paul’s to I Ken, follow-ons

with is buy-and-bill price and respect first The to ASP-driven environment. this and of sort

sort that’s more I with fully think and be our to comfortable, environment what how for physician this price informed to a left transitioning have to a biosimilar, patient to Doctor, interchangeable been product and you of point going feel converting converting we don’t wait start. your We us we One a patients. to a can means that Interchangeability and that’s by us intend message FDA. fresh long-term, interchangeability. can experience in about are that deliver. the manage for a do. This stable has UDENYCA has deemed to comfortable

Ken Cacciatore

Thanks much. so Great.

Operator

from Please ahead. go Mizuho. Salim comes Syed next question from Our

Unidentified Analyst

taking for Thanks for question. is This our Bennett Salim.

please And the would getting remind application CIMERLI syringe for has on-body example, sold given Do please Thanks. timing some could submitted you share on presentation. expected think that not? having are if that key presented if you pre-filled color injector or quick format? be most a this today to one, us capture presentation UDENYCA could provide significant in you been If for really this

Denny Lanfear

All right.

question Consistent And respect think to we you that to upon bullish With comment of on Let let But market. I’ll filing intend disclosed for me for our competitive regardless. the Paul entry first. to proceed whether strategic reasons. will we Paul? I forms for comprises take the remarks, hear as for silent to ability injector launch. that the we its the not the the have CIMERLI, on barrier that do in PFS shorter dosage the any remained about disclose and/or variety alternative timing a UDENYCA. to again, We’ve approval Paul reasons, term. is in on-body pretty probably last of with prior not But

Paul Reider

your question. for thanks Yes,

So you it’s before were got look, these doctors the remember all presentations the using. that that to were launched, vials

and medications. these So a can very standard way is that deliver this they common

don’t major see a it CIMERLI adoption. And to so impediment we as

recent the for most quite can of Vabysmo, has the which I been think presentation. Roche’s see you And point vial to that you example in that is a uptake can launch of only steady.

that want doctors that vial they I a use So whether use think a it, will it’s shows product, to when PFS. or

Unidentified Analyst

Good. Thank you, guys.

Operator

Our ahead. Please question H.C. Wainwright from Company. of from Tsao Douglas next comes & go line the

Douglas Tsao

for Good afternoon. Thanks the question. taking

need back on a already will to do as market. going sort you’re Do of you the expect pre-filled you that there think be Paul, offset that, in make? Or CIMERLI offering proposition sort you incentive to it to puts that that you syringe syringe a a point that encompassed versus product putting that pre-filled physicians? to need and into offer value you that it be value some of Just of going and the syringe taking and the additional itself? sort an a of work how do a vial And into vial terms putting a additional or won’t in sort much of of from sense into from have for

Paul Reider

Yes. Thanks your for Doug. question,

competencies patient value contract the see and One into place. have includes characteristics early know understanding that portfolio, it Coherus proposition. of every We perspective whole as we at all from demonstrated come dynamics the core services the That the is the of product our well brand, of as market. the the complete and buy-and-bill with UDENYCA some

to So we retinal need we’re to the do going we specialists. the that irrespective or of And with what know vial deliver PFS.

it, few Or ahead staff can vial. those takes it retinal pull they their and us the to PFS, In time. or – do not seconds takes a how to up vial do either it they it draw a terms more if out in But of it’s compare only much to versus obviously, whether of of minute. room, them takes the told specialists or time it the of have they have the the timing most like

by a in So launch. evidenced of again, deal that big it’s think don’t I kind Vabysmo the the

Douglas Tsao

the helpful. provide follow-up. just you – – Great. now PDUFA just Okay. commercial then in a for to where build-out an the That’s And organization as you date are in just have the you of given of of can that at I end going toripalimab? was terms year, the a Paul, terms of update

Paul Reider

field-facing just still oncology leveraging field account from representatives field. teams I mean, reimbursement, I are to mean teams, in Yes. payer key I teams, oncology out, – it’s got build where MSLs our current we the Doug. we’re sales our our

it. expected have year. been built earlier So out. moves services is launch for built everything this is And already this Patient

we So soon we’re switch ready approval. flip get to as just as the

ready So go. to it’s we’re

Douglas Tsao

that the approval? happens should launch, expect that upon right And we

Denny Lanfear

The is December XX, PDUFA Doug. date

I [indiscernible] think we get we’ll we’ll is will think yes. So question – early this launch early XXXX, think get I don’t But an your I an

our may very remarks, it in early we in You as note XXXX. characterized

– you the the than for different the so. questions. that’s So beyond quarter Thank

Douglas Tsao

and Okay. Perfect. the congrats so Thank you on progress. much

Denny Lanfear

Thanks, Douglas.

Paul Reider

Thank you.

Operator

Bank the from ahead. Burgundy Kirsten from America. Please comes question of next go Our

Jason Gerberry

me? I think maybe, Gerberry. for question guys was Jason you the Can hear me

Denny Lanfear

Hi, Jason. Yes.

Jason Gerberry

Lucentis you But differentiation the and Okay. How broader the as Great. a was payers and VEGF the then I versus eat thought grab a little versus product long compete or other launch? swing early at biosimilar to the specifically guess Eylea? about have biosimilars. least differentiation can use category like the think decision decision something with plumb share brand, there. it you from like to economic take biosimilar. talk you on? do the the can think into to the introduction I Is about that we it’s the forcing by I bit Maybe either you or a will products the think And that that

face So volume in as brand half? didn’t that trade-offs the there other from, lower world versus of frame practices can providers you good specific expect biosimilar better discounts Are you that economic second chance segments say, care get a the market you you in with to have Maybe this think winning? the into innovators. at the help a that going new the health

Just positioned win? curious you’re to best you where think

Denny Lanfear

take we of what at Paul, one. do do shares, first what the Thanks that? Lucentis shares guess going – think how Paul the the do is shot you market Eylea issue first you the we for about sort that I do let with reformulated various about segments, and the VEGF, portion the of – after question. I’ll Avastin about the think how think

Paul Reider

thanks your question. Jason, Yes. for Hi, Yes.

high the So historical efficacy with of to opportunity Lucentis our convert what much of will And strategy. interchangeability label, CIMERLI I of want safety designation, and outcomes you And confidence the as same core a them right That’s that consistent with physicians Lucentis will sort give the business as that’s provide see of the degree that’s in really today. reiterate experience. our us. the very primary of to front

very another But we we product. is to positioned might side of physicians That’s be off choose at to to the patients number So that of a that’s drive They’re VEGF going one. well be transitioning believe next to through help that know commercial payer the that require where lot also conversion. we a And brand. what VEGF for of And want business, them adept products different step to on that reasons. Avastin.

economics, our tells the based Lucentis practice penetrate – us to of also high edges we access, have degree based ability that only and Avastin those So Eylea. market on of but on that the not research

marketplace. pick our And There’s opportunity So to versus strategy. to going that’s the small across going be not big. entire we’re

Denny Lanfear

Yes.

question, I it’s fair think Jason. a

in these The other are lot versus clinically, that a Avastin would practices would flavors point I all significant products. the a I of though, thing three to product reformulation say, Eylea therapeutically significantly versus And that out, use, cases, these Lucentis degree, interchangeable. is of

to think footprint and really designation, that degree credibility of establish a which and market, then with market. is Lucentis get we our interchangeability So important into we portions the take the the that significant featured

on. those talk value able them patients, to the so CIMERLI to same doctors have and We’re the Avastin and proposition patients inform who very about Eylea and

chain before, we our enter we’ve said an to as is ideal place market. this So VEGF think over

we’ll are we a things how things it’s next probably see be Just rolling of about year out. better after go, QX fair how question. fast in maybe a But place when now to the that talk

Jason Gerberry

right. All guys. Thanks

Denny Lanfear

you. Thank

Operator

Please from go next Our UBS. comes ahead. from question Verma Ash

Ash Verma

questions. Thanks for taking my

I So two. have

thinking coming hold? how one in for YUSIMRY? one. XXXX the So that’s obviously, meaningfully the ramp or So just like So discussion are you are revisited contracting for XXXX with going agreements number you was you be to will question the think about do mid-XXXX,

mechanics CIMERLI. this for one, understand interchangeability the just trying I’m The of second to

a a writes formulation script only vial PFS? when the product your could interchangeable script? physician replaced script words, So can or matter Like it something, other is for a be what be it is? in vial no Or by

Denny Lanfear

question, your for Thanks Ash.

think in the CIMERLI. will one time. July to entering the be for We participants take that that there market me first course, of XXXX respect point same with Let same several – at around

be second market it will that penetration XXXX. will We say the XXXX significant there be We think, would of for yes, there But would Certainly, the significant year be accelerate sales not will I XXXX. contracting revenues that. in in or XXXX insignificant. and in

pretty that are have time. licensees with question, ability came structure to market same in same cost of the our at in volume that on. second market that and our feel insights all boat, our think respect structure and With pass over much to Paul. to and so I significant But produce on our particularly advantages I’ll we the the to your we respect one

Paul Reider

Yes. Thanks, Ash.

So making decision, the the dispensed are product interchangeability it to and and products the have so they bit buying drug, are designation. a pharmacy do the typically it. right, allow the conversion, for physicians it’s nuanced that billing little interchangeable a administering is through because as long market pharmacists the for the buy-and-bill This

– on Lucentis. It convert that’s give they enabling the So in the get their the And already will to our with key retinal can consistent interchangeability that going Lucentis specialists outcomes to be really safely ability designation this historical point. is patients confidence to them the case, experience.

nuance. So that’s the

Ash Verma

Thanks. it. Got

Denny Lanfear

market. so more allow to to that. why get conversion That’s drive And you will that, the thrilled some of we course, are in

Operator

Tsao Our comes Douglas next from Co. the & Wainwright Please of ahead. go H.C. from question line

Douglas Tsao

question. Thanks follow-up taking for the Hi.

Just the Paul. as sticking of to one, interchangeability, or subject quick just a Denny

YUSIMRY? this a like retina Just curious, Thank anti-VEGF you’ll you with space it important the something think face you. with what than for is do market is buy-and-bill designation more for like Humira and

Denny Lanfear

Paul, you shot that? take at want to Doug. question, Yes, Fair a do

Paul Reider

sure. Sure,

is YUSIMRY, a the And dispensed that certainly, nature specialty So product and PBMs pharmacy formularies. that, of high-cost instituted by of and benefit restricted payers pharmacies. in Doug, because

going – because decision. the really So is they key. originator day, payers why of the end guarantees product be to YUSIMRY And place, our important. That’s didn’t at the the why going with deliver expectation will we to to be presentation dictating interchangeability to competitive that’s the and a similar product very pursue are a by make selection. payer That’s to the and

we CIMERLI, specialists know as also the Now routinely one know to really inflammation we another. retinal sensitive for are therapy that we mentioned, to But eye. they’re in patients the switching from that

question help the safety new as as well the Lucentis conversions answers will drive of the starts. designation expect been distinction again, and this us there. Lucentis with give CIMERLI So greater efficacy, has population patient them, hopefully, confidence same which will But your can therefore, current with they patient that and

Douglas Tsao

helpful. That’s

Operator

would like the for closing to now questions. turn call That concludes remarks. over CEO, I today’s Lanfear, to Denny

Denny Lanfear

be New conferences week and I like much, on very joining you Wainwright us the Citi today. September conferences thank of week for participating Wells and H.C. to our in XX. Thank September the York we point in call and all of the would Fargo out just in you Boston that will X

also have and road call. the September, on of to non-deal During number going a we’re shows answer

you. of forward look seeing much. to Bye-bye. Thanks all we So very great Have a day.

Operator

you conclude participation. gentlemen. does today’s you, ladies This for and Thank call. Thank your

now may disconnect. You

Coherus BioSciences (CHRS) 7 Aug 222022 Q2 Earnings call transcript