Earnings call transcript Q1 2023

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Operator

Good day and thank you for standing by. Welcome to the Coherus Biosciences Q1 2023 Earnings Call. [Operator Instructions] Please be advised that today’s conference is being recorded. I would now like to hand the conference over to your first speaker, Marek Ciszewski of Investor Relations for Coherus BioSciences. Please go ahead.

Marek Ciszewski

good and and joining you Crystal us. you, afternoon thank everyone for Thank press announcing earlier for issued release We a today quarter XXXX. the of our first results financial and on This be Form the is also Coherus X-K. release attached found BioSciences can our to website includes current about Today’s forward-looking future regarding statements events. Coherus’ call expectations toripalimab our FDA not share our in to, products timing the them, revenues gain and ability include, expectations for necessary timing to all gain about our inspections to of BLA the required complete statements are These demand, future limited profitability. approval the for approval, for expectations of ability to but China to any and launch about ability approved market expenses and are our of return for new of any multiple products, risks by statements achievements performance statements. results, and that forward-looking cause and implied are or control these involve those beyond forward-looking could from uncertainties our All actual to differ substantial subject of that These risks we guarantees release the the statements as that are issued press and documents not and today future file well to discussed our SEC. with we uncertainties as substantial are in that are performance

Forward-looking statements as undertake this revise made duty today provided call we or and any on to update statements. are no forward-looking date of the

Chief Chief Paul indicative Financial Chief Officer; XXXX results Officer; call Lavallee, and are CEO; Dr. results First Medical today’s quarter periods. Officer; Rosh Chief Reider, not of Development me our McDavid future Theresa Officer. Dr. on necessarily Dias, With for are Commercial Lanfear, Stilwell, Denny

over Denny. turn call the I now to will And

Denny Lanfear

XXXX call. the of we you all over the for year. Thank us stage the you, our growth set joining thank QX, Marek, QX rest on In for revenue and

including pipeline transitioning first multiple immunooncology for toripalimab. presentations, our across a product with agent, or X throughout plan and single product launches we one company, As our XXXX, products from execute diversified

at the launches CIMERLI driver quarter, increased later for includes, beginning as launch progress UDENYCA A increasing ready support implemented catalysts is this this Demand Q-code which first, emerging for the for on April. executed strongly in month. growth now This share year. pipeline. was we expected. and now market the of This auto-injectors of key

We Manufacturing and to Humira is later in inspection all biosimilar support YUSIMRY, inventory. now approvals built the gained this to ready requisite facility scheduled are toripalimab July, launch month. our for having

We expect later on-body of and driving the XXXX, share positioning and approval the gains. launch the injector UDENYCA franchise in additional strengthening

revenue we opening sales being toripalimab will Officer, Rosh Dr. and our our toripalimab program. on of remarks, impact my Q-code Commercial progress combination update you will Reider, signed Development data the the as Dias you ILTX Following Paul start well other developers. BLA Chief on studies you on the CIMERLI accelerate progress will growth our plans new drive Officer, QX XXXX. at throughout expect our inspections, clinical further for UDENYCA presented Lavallee, CMS Theresa and QX, to in bringing the status quarter, newly Officer, the which of review Chief Chief update second tori the will of on and the our then along manufacturing with Dr. starting pipeline UDENYCA update Medical ASCO to on update toripalimab launch TIGIT XXXX I approved sales sales on our as the U.S. auto-injector. on our the then

product the that anticipate to reduce our revenue during will launches, XXXX. of profitability in the McDavid know, you will jeopardizing Stilwell, without on we tightly additional drivers you who detail taken product key measures provide Chief managing very our As focus have our sharpen return success expenses Officer, to we actively on some Financial focused been on our potential. QX company expenses, operating ensuring to sales

the Officer. with And Paul? Reider, I turn over Chief our Commercial call that, will Paul to

Paul Reider

of biosimilar expansion with Lucentis launched growth this Denny an quarter year. I of revenue to on afternoon. in our commercial line potential four top last I CIMERLI, good products year The and you forward. fully expect XXXX, provide will in drive the this portfolio. we interchangeable you, fourth product going Thank the will update a launches with afternoon start

to existing is million market second, first: represents Our and or strategic grow through maximize the Lucentis approach which business, other conversion, anti-VEGF patient starts products. share the new annually; units from currently X conversion

received interchangeability has that transition complete can the While patients safely they them with retinal specialists, treated label the with by CIMERLI. been confidence Lucentis well currently giving

outcomes. correctly, clinical more, executed payment under miscellaneous hindered of has same and the And practice in disrupts J-code expect delays which even payment miscellaneous code X flows. adoption a conversion the errors, the prone interrupting Use result billing or cash We is if of to months flows.

by start slower electronic CMS activation which certainty. providing our sales of faster enables with CIMERLI much expected Q-code product-specific to billing higher the automated payments until thus permanent We

The within QX and Accordingly, CMS it practices are fruit. from target respect confirmed payers we efforts the focused XX% to obtaining getting our Q-code. electronic payer of reported reimbursement and providers XX, of billing as Q-code, With in of efforts days receiving front have across billing. the permanent Q-code using April bearing when XX the Those payers. deployed reimbursement full and over have loading new ophthalmology

over sales. We demand. about XX% QX month entire have the expected seeing unit in X,XXX XXXX the the demand are which of now April, of Through increase shipped we represents

ordered have CIMERLI QX, XX% accounts the potential those, that reinforces number these And Of to CIMERLI begin during once reordered. of of XXX. CIMERLI accounts we was Also share market of which adopting. XX%, ordering doubled the accounts

see would QX that prior reporting doctors expect As for deploying that are to Q-code, in they the same the momentum are Lucentis. seeing CIMERLI built outcomes with to they clinical

disease launch This the was quarter an the X.X% on average fuel quarter demand QX, resulting specialists. efficacy So, track time, in given retinal at and million excellent first patient was that of establishing prior ranibizumab in QX. in in is for compounding year this new begun inventory and and of reflects the continue million the trajectory. safety the of helped injections, quarter. hand $X.XX $XXX the for exceed in with were share for compared revenues X.X% will with end to the normalize frequency products. CIMERLI an XXXX, of other expect Therefore, from and and quarter, growth compared to At conversion to the a doubling million. same chronic $X.X starts record we to have levels successfully Reordering CIMERLI sales market results higher CIMERLI of nature QX And

the UDENYCA presentations I starting our year. new will and franchise, two now turn the plans for oncology to this with launch

not share average As a to this differentiated would and continued objective we patients to future maintain regain share. market we and a but year, the the selling price for with proposition which syringe that innovative presentation you past solely we compete as our year. is strong all competitive strategy additional in two product know, filling presentations value increasingly unmet providers, provide as to needs to these to price, by pre-filled you Accordingly, our segment pegfilgrastim power is on pricing told ASP launch to price the reflected linked to erosion. preserve the on The same presentations launches that presentations sacrifice are new launch

This This the unserved UDENYCA the customer represents has first this overwhelmingly and is device, confirms Onpro, segment We positive. that Class by innovation market pegfilgrastim month. later the large auto-injector receptivity there patients under auto-injector a provides X Neulasta of flexibility, highly and plan convenience, on-body XX independence to in seconds. been alternative to administration which launch drive presentation quarters. in provides certain increase retains delivery Autoinjector thus has XX% share and providers UDENYCA Onpro desired and a over the the market. the coming potential market to still

quarter, non-recurring XX.X%, one decline undifferentiated a from normalized; higher with competing quarter required factors: $X.X liability from from contingent last wholesale to prior billion, maintain in our from the share pre-filled resulting levels to $XX competitive of X% price first, were sales dispute. have presentation. inventory market the was prior the XXXX segment, from a finally, which in quarter QX end million decline and charge resulting UDENYCA key arising net a net now four of position a And the X% selling at QX, declined syringe a

second the is beginning believe we with pre-filled half forward, now franchise market share syringe with brand, only presentations. UDENYCA XXXX. the regain of both auto-injector to Later Going well-positioned and pegfilgrastim in is the the UDENYCA maximum brand penetration presentations. the growth a for market this will if provide approved, year, product path pegfilgrastim This year. this share will is market be on-body we and injector three all only

if the expect launch toripalimab, to our We some next. Launching approved. be our cover franchise. step product We plans forward bio next first company’s is a immunooncology our advancement of launch of oncology the critical in

new indicated patient Today, therapies including example. excellent high no U.S. unmet. a of extend pharyngeal first proof therapy cancer all and different to A carcinoma, inhibitor. and to lines only PD-X patients in nasopharyngeal is next-generation first carcinoma Our will in survival and relapsed a PD-X new hope and inhibitor the IO to a the treatments, line. be including establishing Toripalimab metastatic FDA-approved nasal have standard offer mission patients constitutes care of NPC therefore an is is for

state toripalimab’s toripalimab community, on and reach pre-launch learn state join healthcare we education is at could launched designed such, $XXX that for sister to market Preparation patient confident their million the also share be launched. tailored We progression. patients professionals As will each we activities. chemo to disease and and share site plus launch, The of npcfax.com, which information is us NPC. enabling stage feel dominant executing created to NPC opportunity of for gain is at a disease are commercial that disease and patients to estimate NPC allows of source our primary caregivers peak. a market their about a to Npcfacts.com each caregivers for number

is U.S. with engage Our end by identify year. aspiration NPC of to in the patients and appropriately the all the

of our of to so at the toripalimab’s of irrespective impressive mechanism be survival benefit, demonstrated train oncology force, educate PD-LX doctors will expression ready status. patient at to continue they launch NPC and differentiated sales action We

look A toripalimab. upcoming will featuring a leading these and benefits program the launch physicians Finally, will and cancers forward peer-to-peer educational sub-modest head investment of patients neck opinion NPC marketing on and field providers we required the be in engaging with we the leaders and KOLs of nation’s ASCO. to educate and at to the identify

capabilities oncology our toripalimab into toripalimab built efficiently existing to between being scale Our UDENYCA integrated commercial oncology customers Therefore, infrastructure. and overlap significant were is prescribers. commercial launch the with of targeted

across of to all NPC and We of population entire successfully are expression lines therapy upon launch irrespective the approval to status. PD-LX patient ready expect and address toripalimab

and on I will comfort. criteria. a our is have presentation. track that includes feedback well-positioned a and used product YUSIMRY XX-gauge formulation YUSIMRY to July. which will to launch our biosimilar, the maximal citrate-free criteria each key with proprietary these are state-of-the-art patient It confirms of and supply robust presentation Humira non-stinging is auto-injector on formulary to Market in YUSIMRY, for decisions price, end compete needle making

with launch YUSIMRY units July. at of volumes We will supply have hundreds distribution thousands in substantial ready for of

summary, in call on our we are we approach and ability to in top launches over more commercial our are at point our We updating new our after revenue confident inflection will launch. product next detail and August X In our and we the you of ongoing and look years. strategy story five on now line growth drive the forward

I will now Lavallee. turn the over to Theresa Theresa? call

Theresa Lavallee

good everyone. Paul and you, Thank afternoon

projected Let and inspections me with begin an update our toripalimab on approval.

and make the diligent travel to the and know, to you restrictions partner, month, were this the wish inspection COVID for our the to is was eliminated December to half Junshi related thorough XXXX. PDUFA thank application restrictions now in date As NPC a May. toripalimab of pandemic success. China, In We inspection missed for Biosciences the January, preparation in for the efforts COVID-XX second their scheduled due travel

breakthrough note extensive The With and designation The there has FDA warrants clinical that are no we identify of is recognized The BLA, the assessment respect now therapy of regulatory data FDA to support for approved as clinical BLA treatments unmet deficiencies. toripalimab any MPC. consistently the again flexibility. granted the and the to an need substantially stated remote MPC review sufficiency this the complete. regulatory did not MPC conducted agency

has and survival with site combination inspections. work PD-X FDA types with irrespective a an in to to benefit PD-LX clinical is differentiated next-generation the mechanism a of continue with demonstrated Toripalimab tumor action impressive of multiple in complete chemotherapy, We status.

observations, we better studies these conducted basis on Based understand mechanistic to differentiation. this the of

actively preclinical we support non-Coherus PD-X that seeking ideal evolving data a pembrolizumab. novel describe. present completed demonstrating submission necessarily use toripalimab scientific meeting field as Thus, are our has compounds. just Dr. Dias pipeline the further at toripalimab the to expand will to year. MPC, potency for later toripalimab’s that in We this journal on we not T-cell all additional combinations, a this believe our We safe are compared makes as have foundation that higher an And agent activation or equivalent. for the to antibodies These for understanding combination well development findings IO as studies plan opportunities with beyond

pleased also the regulatory at as YUSIMRY In continue am and approval for the first I the Coherus’ a to very execute change to high teams auto-injector manufacturing. facility gained report quarter, for well large-scale as manufacturing level. that we

quarter. of on-body presentation Additional well look approvals included presentation, the injector auto-injector the UDENYCA’s we the the for supplement is year. this fourth approval UDENYCA and to forward approval BLA progressing

Lastly, I recently and large-scale the to successfully We transfer plan to prioritized can to rent of completed manufacturing qualification regarding the tech engineering have supply. execute States, the lots efforts. the these toripalimab we’ve fall report this onshore that process needed United manufacturing

Coherus Officer, Rosh? Chief our the I’ll over now IO for update turn a pipeline. it Dias, clinical Rosh on Dr. to Medical

Rosh Dias

squamous continuing everyone. positive Thanks that of its multiple cancer, two We the top to tumor partner as carcinoma nasopharyngeal of differentiated with form across Toripalimab cell very combinations. and data cell effectively afternoon across a of immunooncology mechanism of good believe position in pivotal continues publication carcinoma, lung of being the and will toripalimab together choice action journals, much, backbone esophageal franchise. Theresa sets non-small data types, released our

ASCO lung of Several accepted been X/X survival cell types perioperative and overall in the across the or will cancer non-small analysis from include multiple for have TORCHLIGHT meeting. data lung recurrent tumor cell with the being triple-negative and XXXX presentation toripalimab survival upcoming well at datasets as settings non-small NEOTORCH the Stage cancer annual study, cell be of Metastatic non-small biomarker data CHOICE-XX, treatment breast These tumor final cancer presented. presented entry as first-line from in data study.

or We and XXX results. will treatment, June clinically presenting final the be Monday, on X, survival shows metastatic registration analysis statistically study recurrent NPC also the in of which subline significant overall

at This With respect Medicine X/Xa Phase year. ASCO in our is will the Nature U.S. BLA XXXX with our excited positive toripalimab the upon presented plenary the pipeline, build about which forms in active NPC. session we and next TIGIT currently and progression-free the our of in survival in anticipated data basis XXXX to remain study submission internal results

addition, remains ILTX asset the track of towards IND end In submission our proceed we on towards as year. this

Officer. David? to over David now Chief I Stilwell, will our turn it Financial

McDavid Stilwell

from XXXX. Thank financial auto-injector this our and we launches reiterate project of and accelerating with you, UDENYCA We body sales Rosh. CIMERLI prior toripalimab year the Today, CIMERLI for guidance the injector. revenue growth and and on

$XXX with with million have expenses implemented the force toripalimab other XXXX of development we $XXX Along For joint in the we expected committee. measures book rescoping year, of least with full net product $XXX least quarter, measures in the of we net to and first to operating In a took last the year, sales, SG&A a range we at at reduce R&D expenses revenue. million. significantly expect to million million and CIMERLI reduction reduced $XXX to

in milestones payments, stock includes upfront and non-recurring million compensation excludes approximately range expense. $XX non-cash it This in

requested quarters start we and the through available auto-injector would not our and revenue until the the for CIMERLI a the XXXX, May. until the UDENYCA that X would recognizing of the waiver During of of not April code that first Q obtained loan term covenant launch be two year,

approximately XXXX. the share in million XXXX. for $X.X quarter of period and the as compared with loss a $XX.X connection a million press and filed in $X.X share. touch to million few the we UDENYCA of was for in a today Net XXXX I’ll of From per $XX.X the or million million of financial afternoon. quarter for in same charges my revenue and highlights XX-Q details sales $XX.X was first on just diluted or restructuring the incurred Net non-recurring March million XXXX per a diluted to on X-K net of CIMERLI. release, quarter the basis in net basis, loss results, review $X.XX We On sales $XX.X of first $X.XX are this of included first

a million as Net a revenue includes decrease was gross the price. mid-XX% ergo, contingent first COGS includes during a the realized the Net compared processing UDENYCA one that a net our royalty same COGS on million $X.X UDENYCA for to payable of year a quarter of $X.X quarter dispute. non-recurring with inventory UDENYCA X first lower during resolving to primarily mid-single-digit units sales liability included COGS to well Cost of declined million reduced related net due fee of $X modification a manufacturers sales of were ago by quarter charge that two one $XX.X royalty manufacturers. million XXXX, XXXX and of a in on a number in the sold of to sold was XXXX. a profits. goods as first the write-off CIMERLI through our items, of of low and contract of at half damaged Recall

for expense excluding $XX.X when development the quarter after the R&D significantly million $XX.X Biosciences ago million, TIGIT-antibody, paid was CHS-XXX. a year of and Junshi reported for fee to the license than in Research lower we quarter million XXXX first $XX expenses

and activities XXXX expense launches are new first SG&A force. commercialization expenses costs support XXXX. of the in reduction incurred CIMERLI current and with SG&A associated R&D expense sales We recent anticipated preparation general multiple for of million in the quarter the for included the roughly equivalent $XX.X first in administrative million, to billion the same recent period expenses for with first reduction associated quarter Selling, $X.X the in XXXX. by in expense of product UDENYCA was force. $XX.X XXXX the included $X.X of million costs costs and for to primarily driven for XXXX of in SG&A quarter

XXXX quarter introductory burn the as elevated delayed at $XXX.X investments cash were by for in first securities in related the year-end. launch, to which and specific terms XXXX the by of million quarter $XXX.X was cash equivalents compared receipts payment impacted for of to and XX, was headcount sales. million marketable costs March Cash, CIMERLI further product Cash

We of our the of we cash year. receipts expect the XXXX, launches second half ensuring generation success focused of revenue to are timing new normalize the In the anticipated growth. and of the in on product

control we to a expenses return our aim profitability XXXX. operating in We toward continue to as maintain will tight potential over

turn the to back Denny. now call I’ll

Denny Lanfear

McDavid, you, on QX our call. thank all for joining Thank us and XXXX earnings you

quarter. second accelerating Now in in to see look the of summary active is Q-code year. throughout these the forward impact the We sales some

this innovative product market gains our unique study our in of of safety Development in auto-injector, UDENYCA physicians the On foundational across launch efficacy a asset option UDENYCA franchise patients well. presentation, driving share later a after the new our strong UDENYCA provide month and tumor and front, continues is immunooncology with to will types. pegfilgrastim demonstrates study anchor progressing Toripalimab, and differentiate multiple

PD-X agents in cancers. this we’re month, ideally occur combination physicians next-generation choice QX. those the in treatments will a is the manufacturing proprietary with number and that scheduled their optimistic the cancer For nasopharyngeal inspection indication Coherus of first partner own developing for of The approval

Lastly, to XXXX. while by progress achieve savings drive million expenses in revenue in the we’ve $XXX about and about to our continue look increases controlling as $XXX expenditures expense reduced we we to cost XXXX our for profitability control, to and efforts more thoughtful efficiencies this significantly million will and

ready the Operator, for we questions. are

Operator

Thank Karnauskas Securities. question you. of Our comes line Instructions] [Operator the Truist of from first Robyn

open. now Your is line

Robyn Karnauskas

great manufacturing for getting And the congrats the news. inspection on thanks Hi, that’s question.

I two really brief. questions. I’ll So quicker have be

tumor. release been the a Junshi there was like So partner with to typically by given it inhibitors, which second around has on difficult treat cold cancer, your cell tori, lung very small press seems

about is you And if does people like overall thoughts a UDENYCA. are new tori seems the And how you this interest deal that. forward? So collaboration are driving about the your response? be like It and epitope worked this this strategy a bit going differentiated and how in questions there where do dataset? it so where would on at have MOA then works SDLC, pretty your with is partnering a What much I talked big had little one change then given few think on I on talk how why

Denny Lanfear

question. that address morning. Thank you, let the see Yes, cell Robyn, the were very pleased this to data small announcement we Lavallee issues. Dr. I’ll for

your So mechanism which subsequently combination agents, of question, the including have is Dias Theresa? these cell Dr. of I’ll action in indications, address or other small secondary toripalimab, potential

Theresa Lavallee

Robyn. Thanks, Yes.

of in with benefit I Phase T We are excited up clinical survival positive This call our about some toripalimab pembrolizumab it, X positive studies not tumor that consistent study results toripalimab difficult combinations, other shown that a preclinical rush, are think think PD-X to see another particularly expand has with further. at showing with well has to compared antibodies. potent to activation more cells really really that and and

Rosh Dias

the question. Thanks, Thanks, for Yes. Theresa. Robyn,

I you’re right. So think quite

lung all that out represents of real to unmet marginal and looking about small to at continues cell XX% here. is current extensive think all, First a are cancer, lung have there It XX% cancers, pro-prognosis there I have therapies the need a stage, benefit. to of continue

were So we types. about in know, across I of co-primary think very are benefits space, different think as think think multiple add the I And data stage the continues and the look mind, to this OS, the we you just with endpoints. available both excited at overall – to breadth we tumor if that PFS I I

results. of in cell do in well lung via TORCH cancer non-small lung cell alone, have think positive cancer, this additional without XX really other also small cells, across now but mentioned additional data cancer lung forms all also Choice perioperative JIE sets we showing lung and we As combinations for up then that genotype for now small set. I and

Denny Lanfear

as pembro an in we all and although additional cell-based studies, from outperforming implications array didn’t quite now. this, with consistently remark respect to agents broad PD-X it selected such of and understand a available of years other vitro some X various saw when ago, Robyn, agents, we we the just toripalimab

rewarding really Dr. mechanism of where think story readout the readout all, to also efficacy. it’s several indicated, a perhaps, very far potent record UDENYCA, I but first follow-up cancers now you rewarding, had action very question as to in said, as see demonstrate on to see I very of that, here Lavallee think it’s you that this With as as a said. toripalimab continues, we track

Robyn Karnauskas

differentiated the given small an data. detailed that I’m And you of auto-injector Asian-based any early that syringes. just Do excited will doctors and to get it’s of be that’s payers I the how sure mean, on markets? Yes. mean a sense are the I have being given read do what and the these sense study, really super better how three now? really view And to help publication share the identical injector is trying – one see think I’m the products a one, auto-injector just this then device different fact you out or about about question the the and an whether it’s auto and that you getting taking as three, or going for – that interest on-body tease we us on to Thanks. you’re do the have the in and like pre-filled presentation auto-injector

Denny Lanfear

question. great a That’s

out that frame you. Paul let for I’ll So

value we’re proposition dosage all, which the differentiated then on with of some on to today the secondarily, the for various front, the that and are payers progress the compared that making is with Paul. forms, the First auto-injector of market

Paul Reider

Hey, really second growth the we expect and auto-injector we’re later question. cause thanks increased the some to share and the market in quarter stabilization launch your then Robyn, will this month, year. half excited of Yes, it for this

the do both more auto-injector where share. competitive really to compete competitors. important it There do ones. also effectively to us in I think now enables that is it enables pre-filled three with in in-clinic market against in the because still compete segment us But And will the the now XX% has Onpro benefits. of patient is syringe segment at-Home the the to

injection will give experience. over First is patients more the their auto-injector dependence

when to they of where So And ease use. the desire. and able essentially, is they’ll be second inject

the actually third can and got than – we patients the be to seconds XX-minute of this this an to simply we to So do and to can live where time. for delivered XX believe today, coverage penetrate body coverage through navigating day you plans. nicely. it’s is flexibility payer back able auto-injector XX% and come coming in for injection very or we’ve who entire the And away all can’t a opposed to far going so over the the less be coverage office, Where as online is our have market segments of those confirmed then

launch the on with is it we formularies few months. to be and now in team So working ready will getting customers,

Robyn Karnauskas

Thank you.

Operator

Thank you.

of question next Salim with Mizuho. comes the from Our Syed line

line open. Your now is

Salim Syed

Great. questions. around Good I another guess is peak Just on about can, you pricing on perhaps the get all to reach for my on million. On by if for disclosed then were Paul, if lines? Thanks be but couple net math, peak number patient? afternoon, your actually per if that’s you to a curious $XXX $XX,XXX something NPC, point toripalimab know and framework haven’t a mentioned all one believe able the here, based you that would me, ballpark your sales guys. tori, a can you I that suggest correct patients, on million you like price UDENYCA. $XXX could us I in into right if direction you

Denny Lanfear

of we products, policy, don’t are which on that Let matter a – approved. first not take comment pricing on We me as Salim. one,

product there have on revert about, of be approval. pricing. I after little projected So we’re Paul about we do and will a But we we year. the patients both happy other bit X,XXX-plus chat line will to approved, said think, happy care. first But per have we have pricing to remarks, in And as lines his

Salim Syed

warehousing. MPC then on with registry plan how many I’ll just maybe an build my to idea the little currently the little sounded Thank you I if patients comment on approval? a for if warehouse you in on, a give you prior Maybe registry could comment Great. second It maybe guess, of are I you a Okay. just like question toripalimab. guys ask – patients bit bit Maybe trying us can to and how website. your are you. many to Can you

Paul Reider

customer cancer, knowledge about Even really npcfaxs.com launching qualified that the really work be to don’t space, of to place going patients our to the and go company where and get doctors rare Yes. information brand only our centralized was market that’s have a the entering found and we intelligence NPC.

was there. force real so And that the driving

invite Now us join they and community appropriately. And their are if understand then to the adding metastatic, they where patients or can a and we are we caregivers localized we if local, with communicate can them enables educate will now them.

going to be the turning there. up cranking we’re that start the noise to around So up level media really

We our efforts, the through with appropriate be will team website the having disease directly. state accounts field share

hand actually can they in. this So come in out as they their patients

actual on be will that. on we’re what reporting far, out But we we like numbers So there. seeing so

Denny Lanfear

add would them. these patients we treatment and I without toripalimab. these will otherwise know if disease. agent progressing out educate tremendous to and responsibility to are additional patients FDA and we really out reach patients home. have feel toripalimab Salim, approved, only of comment, feel responsibility find approved We patients so and that indicated, Rosh a the these terrible that we And benefits the as These by this for them be to are a to the reach substantial their let

Salim Syed

you. Okay, thank guys. you Thank so much,

Operator

from of Thank Instructions] comes TD question next Our Mike you. [Operator from Cowen. line Nedelcovych the

Your line is open. now

Mike Nedelcovych

I two questions. the have you on Thank toripalimab. for

realize will NPC is is other have bit, set see we you clinical you if potentially may differentiated trial? toripalimab Thank of hinted world the pivotal have your secondly, mechanism and in you. a already the once given next How a advance of whether a go approved. about in is use selecting you displace The I potentially first, indications I’m think but checkpoint then beyond and any that of of profile approved differentiated when little you action there no is inhibitors And the to off-label oyster. you a there sense inhibitor. to this curious checkpoint that

Denny Lanfear

question Dias for Mike, Lavallee Rosh? Dr. actual let question. very the address mechanism subsequently. the much then can thank you Dr. I’ll your first questions address and of

Rosh Dias

So just the – thanks for question.

I’ll couple earlier. of a we points So just mentioned reiterate that

are of carcinoma first no for therapies U.S. nasopharyngeal in the approved So all, there

our is typically. of of is current is NPC an Even chemotherapy, but that NCCN treatment, for what data there other set immunotherapies immunotherapies. typically means actually a though in there because There of treatment on that indication So indication. basis the positive other cisplatin importantly or are couple for standard other not therapies potential no an the include the does the sets is data as gemcitabine

Denny Lanfear

you of toripalimab ILTX can and the of on. comment with mechanism potential Theresa, forward brings so other how or action therapies on combination

Theresa Lavallee

works irrespective target the PD-LX increase CHOICE-XX X ESCC is toripalimab on activate in the status in I and lends in study to true antitumor the and mechanisms combinations with types. studies, to lung in cells that three the two, seeing in study the of potency seen and be the was that cancer Phase non-small mechanism are that to cell frontline which related of chemotherapy large T-cells, cancer Jupiter-XX, across to Yes. really those am itself really studies able combination published NPC to resistance immunity tumor

is pipeline at ILTX, lung such looking is our cancer. factor which which includes resistant backer So, pages, a diseases in as cell known small

with we that hypothesis. looking a the on X be Phase positioning And on the clinical few a disease will with help in strong position to have of number based stated or are engaged we we companies based really have So, disease times, data us compounds at a other mechanisms. as

think later development plan I the this seeing So, you be year, will nice there.

Denny Lanfear

for Thanks Mike. question your

Mike Nedelcovych

you. Thank

Operator

standby question. for our Please next

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

Your line now open. is

Douglas Tsao

Hi. Good taking questions. the for Thanks afternoon.

terms have CIMERLI all volume on still adopted curious their switching I the or Lucentis? are CIMERLI splitting and they from to ranibizumab Just it am are me, typically CIMERLI, question accounts just in of it they between that

Denny Lanfear

one? you that Paul, your Thanks Doug. for question, do to take want

Paul Reider

Yes. Doug. Thanks

for business patient today, new including as standpoint, well therapies, conversions of a anti-VEGF from as a Lucentis. combination other starts of of from coming from As patient source is

this, expected we seeing that’s the what we So, market. are in and

Denny Lanfear

question, have Doug? you follow-on a Do

Douglas Tsao

those curious, indications. YUSIMRY’s strategy have that you in start just to have or fact into seems just focus am of able I because given the sense real you be been you to of to terms really finalize do Also progress just payers a a agreements going launch, be with are from that some to Yes. make your or promoting not

Denny Lanfear

payers in for launch also comments won’t it’s biosimilar primary determiners say that regarding selection pricing competitor the being we the fair we said, insofar the and after conversations product. to That of of be will PBMs formulary July. the previously making for are have that I Well, be indicated focus participant any until any payer payers market this Humira as think

no on So, that’s about point But further which question particular our will this for talk fair comment that a we at August point. QX. call,

Douglas Tsao

Okay. Great. Thank you.

Operator

question. Thank next our standby for you. Please

Balaji next Our the question line of of Barclays. comes Prasad from

now is line Your open. Balaji, there. are you

Your line is open.

Denny Lanfear

move to next the on Let’s question operator, please.

Operator

Yes. next hold our for I will. Thank Please you. question.

question of Ash the UBS. line comes Verma next from Our of

open. Your line now is

Ash Verma

one for questions. the my I on on and Congrats there. YUSIMRY. had progress. on tori one Hi taking Thanks

just I looks [ph] of a site will you heard that’s ago, of as that the or So, if on the whether where high that a study from indications my apply I That’s PD-X. regulatory And then FDA’s the to missed understand like think that other has from a maybe being paper so like any Does question. not years is royalty determination FDA key up mentioned am if that on will they mid-XXXX, was an second, commented on I wanted indications? published a it FEC NPC have Do correctly. curious, make couple I so FDA need and paid just its China does to be know Lancet to been And in these not mid-single first approval, digit NPC there it unmet I point you issue the until confirmation need. flexibility or anymore? just the CIMERLI, for in to of adopt inspection toripalimab, this, still mind, view,

XXXX? that based standard So, timeline? no and you there royalty you on launch your term like is like It’s need just pay to that got a that after industry is

Denny Lanfear

Hi.

royalty to first, digit that on UDENYCA the stated CIMERLI. last a up Let one had take But okay. me not XXXX, we low-single was McDavid

comprises we split a the arrangement with the regulatory of comments, clear. So their that to profit CIMERLI, Lavallee a consistency address will Theresa? it’s the and for in royalty what as status FDA, financial Dr. and that’s question slightly of I flexibility, the issue regulatory your different have particularly what let And flexibility which if is different, on of it With regards applies licensing, FEC. to our

Theresa Lavallee

Thanks New England way they in of it on disease, warrants the to regulatory that – both Journal and practice. Yes. of the the Lancet one It’s several article. you at have U.S. times the fold, article NPC And improved but is the the available several medical they Medicine as complex, enumerated look flexibility, Ash. epidemiology stated, applicability Oncology they therapies, and

that lack of of profound ours of of boxes, need to those the front be see free the in the with resources clinical combination in and and reinstated the therapy they a in us front-line chemotherapy approved to places PDUFA what inspections is year and due particularly if And who study that miss given and And the is so later a that all month, they at can’t go had not benefit COVID-XX weeks repeatedly the one you toripalimab able fact in And at monotherapy restrictions. compete this observed last using and have don’t they volumes a we will, sheet would pink not get FDA designation travel we even with stated benefit usually on to list. jail think cart front the FDA list, when the of the being treatments worries. means those NPC the China. really had out couple second both I date of breakthrough where do, scheduled have doing about the lines. were in China only they said speaks repeatedly just letter, the their you think meaningful without told it to thing to is The they would travel given They the ago, the what that I had

Denny Lanfear

regulatory flexibility. that Externally been very, consistent and internally, nasopharyngeal very very, FDA has cancer or its

Ash Verma

so to you hear. much. Thank Yes. That’s great

Operator

Please for question. our your question. next for you Thank standby

question of JPM. next Chris from the line comes Schott of Our

Chris Schott

so Thanks Great. Hi. for questions. the much

was am opportunities of The that. my get just trying to the from and how for flow-through insulated guess the, presentation traditional first hands the just dynamics I on-body around auto-injector one competitive I basically on UDENYCA. and the are

for opportunity as view kind improved as traditional So, with competitive for think obviously them could do you But etcetera, companies I product a the separate out, in or these guess the much, approvals. competitive the almost pricing these? impact presentations, about we new shake does like kind position the where for markets much environment – of the as of more

Denny Lanfear

I and Paul? auto-injector will to respect let the to Thanks with your Paul Chris. PFS presentations, question reply competitive dynamics.

Paul Reider

and the segment about the come been – to you to largely used There into when the so two where through in-office reimbursed office, predominantly The the ASP. based the patient same same that’s build nurse be presentations think in prefilled in-office progress have Q-code it’s Chris, segments. the we been auto-injector and syringe setting can that where market, Yes. on and that bifurcated is back the preference patients competing. under the

patient able device. alternative. wear – be the the So, auto-injector type share The to the differentiation experience easy-to-use simple, and versus the auto-injector be case, that’s Onpro is there. that of the in in where new a where And market. us on-body of enables compete it differentiated using will the XX% dominant to has of offer And will a a can device largely that other on the had part the and at-home realize segment patient

solution we total this when now the then approved add for we if the later will year, have So, on-body customers.

in presentations So, whatever they a three have office, will whether to unique or the they clinic, at-home, are and they meet are in providers are whether the patients. needs the hospital the a they of

strong us believe years. in will we in So, to franchise will grow us the put year coming share the position enable with and that a later competitive and this

Chris Schott

I is Because Great. obviously those unique will be auto-injector seems like the you see guess the only it what versus on-body. versus presentation competitor, that of I you kind to of And the other Amgen. two opportunities, one bigger guess a versus of large on is of a the market can do follow-up Coherus I is the opportunity? just kind segment

Paul Reider

excited Well, we will going of listen, customer are here, based month, this receptivity how to heard now. we what on are end Yes. have and but very, we really about the see we at very launch unfolds

are going the going happen experience I they of key if fit day, on-body, nurses them. the which be going or to think is want Chris, best constituents, going to type are the to of and it’s identify choose end helping at auto-injector that’s to the what the patients what’s to

to want all the we that that are three strongly. be brand positioned we so So, offers

scratch, patient the the the depending be doctor solution. So, and want we to whatever upon total

Denny Lanfear

has is system, point an with about on-body by walks the patient, attach this a patient though, around that for patient There to is I is additional One Chris, set it to that with nurse, The is be would three-hour the period it. hours. filled the make, XX activate anything. then patients control, And your a the people we a and injection right. a living injection with of with are you, cancer, patients which for loss XX-minute sense, of right. And is controlling therapy is the do aside the there there think basically period in

attractive very it’s time patient the able auto-injector with be a of at for be choosing. their an So, to to administered

segment. most take So, from, – new I I seen that segment will out it has generally PFS, new market. also strong think the it’s a is have take But patient probably a it’s non-PFS empowerment receptivity from very think which in that’s question powerful to segment. To the very a the as say that will your by share it un-served

Chris Schott

you just one on the for of on then until commented side launches. But thoughts any of know me. pricing kind or the biosimilar market just it I or on all And observations Humira last Great. at the would these, with far first launched, trending the or so anticipated I months generally formation market the or guess guess have three is four in months you biosimilar I first that as market? the, that’s surprises for

Denny Lanfear

the a is believe this I think that it’s point. I fair out question, but at jury

I team have on. results [indiscernible] think we made public have and only the so had launch one been

will – that’s to really the July another in. point come formation Humira to the after don’t date and/or market some so But started for start think I have I just the you interest until I things don’t has really market. settle. think you see I market think it see biosimilar other where think

Chris Schott

much. so Thanks Great.

Denny Lanfear

Thanks Chris.

Operator

our for standby Please last question. you. Thank

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

Your line is now open.

Unidentified Analyst

guys. Jason. Hey on is Bhavin This for

for me. So, questions two

March price The to first here, first expect to increase so your auto-injector pricing to as targets. state you there then launch. launch more Day, to is sort increases XXXX multiple XX% the share transition the Investor seen price tandem UDENYCA steady with you. the formats the of new a from goal commercial come in come phase And that the for you thinking about How set are going or leads billion target – second one products? are to where is we back question the market? for Thank we Should have market see you as $X.X XXXX to

Denny Lanfear

Thanks the for correctly additional pricing, a stated there your question. that With with was respect you price to UDENYCA increase I do understand process?

Unidentified Analyst

Yes. From data?

Denny Lanfear

So, you mean the ASP increase occurred? that just

Unidentified Analyst

Yes.

Denny Lanfear

could Paul, explain? you Okay.

Paul Reider

Yes, sure.

Just the as the syringe, to XX% clarify, the Neulasta. to price prefilled be price will a auto-injector same list which UDENYCA discount for is about

you the including the to brands relates that increase the X% did second established in are the in ASP, of it highest we As quarter, correct have innovator. in the ASP, the puts class, a amongst our which it

to leads ASP higher So, higher reimbursement.

for in we why been new have disciplined very preparation on ASP management with that’s presentation these launches. So,

Denny Lanfear

much last out to got respect the With to robustness million about spent year our to market is years out got developing with We pretty as That’s that X that payers expectations. question is about important readouts what to we share, that market I team ago of point quarter. move Dr. auto-injector scale, X was consistent them., very and to this that that’s would The and an playing say, YUSIMRY patient planned. approval deliberately $XX supply, comfort pricing from into large-scale Lavallee manufacturing.

So, just the competing are But go the And in market, with as our long the of scale takes geared I aspects say we forward. we all will get that in given to see we we scale well how benchmark that it at think cost and for I can have – the up dynamics. to with device, totally structure YUSIMRY. that sort for we to in XX%-plus of us terms of are prepared with

Unidentified Analyst

Lucentis I line over if months? can have XX biosimilar to then the next you launches And have months any do XX into of follow-up, sight competitor one

Denny Lanfear

you want to that question? Paul, do take

Paul Reider

Yes.

public understand, are ranibizumab biosimilar a looking they only one based on launch competitor statements. until of are not We and the what for we XXXX from aware

Denny Lanfear

and and Q-code that the go I continue the barriers those of think in Xst. biosimilar with of CIMERLI I on whatever XX different within out to so states. the in customers, one XX number impact enthusiastic customers about garner of I are the think their about very at and firsthand I with a couple impact practices they on the visit may CIMERLI reimbursement. all market certain every opportunity had Q-code, weeks to different last the in key flow, April be on on. talked practices. to keep issue, mind discussed and cash deployed And impact their those had to them though, least four to And ability they adoption and its single is have to four Lucentis and I saw with physicians the And we of

came that’s are acceleration and the the think the and even of in that we and on uptake things data share I So, see additional utilization. market seeing out the some you today why some April

our the So, And the remarks. me case I feedback the previous think that indicate follows directly from customers to also. from Q-code direct for that’s

Unidentified Analyst

so Thanks much. Okay.

Operator

the like Thank CEO At Denny this turn of closing Coherus I time, BioSciences you. for Lanfear, would to remarks. back to it

Denny Lanfear

thank joining everyone you you for us operator and today. Thank

to heard, you look keeping all progress. an catalyst Coherus, XXXX forward our will we exciting year and on updated you be As for of

will that month. at following week, all We you of this later this Talk will Bye-bye. the to be be we at Bank America soon. and UBS Conference

Operator

conference. today’s conclude does participation your This Thank in program. you for the

may disconnect. You now

Coherus BioSciences (CHRS) 8 May 232023 Q1 Earnings call transcript