CHRS - Earnings call transcript Q2 2021 | Coherus BioSciences, Inc.

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Operator

Good day and thank you for standing by. Welcome to the Quarter 2, 2021 Coherus Conference Call. At this time, all participants are in a listen-only mode [Operator Instructions] I would now like to hand the conference over to your speaker today, McDavid Stilwell, Chief Financial Officer. Please go ahead, sir.

McDavid Stilwell

Thank you. thank joining and everyone, afternoon, you us. for Good earlier XXXX second issued a results. our release press We quarter announcing This release can website. BioSciences be found on the Coherus Today's regarding call statements expectations. includes Coherus' current forward-looking to are through candidates and registration. to, These immuno-oncology development not include, biosimilar and but our statements ability advance our product limited

under applicable Denny Reider, CEO Market turn now the actual certain are to of Our today's law. our over on UDENYCA our could future specifically to Denny. of XX-Q XXXX statements and Paul earlier quarter for report we to President guidance statements. XXXX we that - well and quarterly as control and risks the potential as ended to for undertake Thompson, our Securities these are future, all in in with the are Coherus; assumptions, These expense Access; commercialization no And today With and ability are Commercial cause Operations and Chris to that certain and of stated results involve afternoon. Executive XX, I guarantees Exchange discussed will SG&A call differ of uncertainties EVP of uncertainties and and that uses which capital, of our June are Vice meet this this Lanfear, other information, as are Sales. not products our duty Commission, made and from R&D as on me date in required risks of subject except such of and statements documents filed we The the performance Form file update that forward-looking call beyond

Dennis Lanfear

with on I'll our company with a our diversified thank us biosimilar for joining single from UDENYCA progress biopharma our to assets. pipeline product progress PD-X this and and pleased afternoon. provide Today McDavid, we multiple multi-product since Coherus We're oncology toripalimab, with all transformed company performance, antibody. you biosimilar Thanks, a updates

anticipate United bringing to we market years, two next four in products the UDENYCA. complementing States, the Over new

cash product flows market diversified Our asset. durable large the in with and rapidly immuno-oncology our invest and to as foundational toripalimab growing portfolio will generate developing

by me UDENYCA to prior net In to in UDENYCA turn Wholesaler compared recorded a quarter $XX share. second quarter in details of about of point the seasonal the was reported XX% sales the that factor stable the in $XX second in negatively UDENYCA second of was not quarter expectations one impacted we to burn-off market the with will first Now, Reider XX% million end as first Later to by let million revenue the respect provide quarter additional a the nine compared in the of XXXX. at as year-end first our of quarter-to-quarter half accumulated share and IQVIA revenue. performance. to Paul days declined inventory was UDENYCA. buy-ins for from second quarter. XXXX, the quarter Recall call, inventory wholesaler

in billion Now, Lucentis, $XX with let progress demonstrated already share opportunity. our Avastin, biosimilars the we're of significant areas Together with on biosimilar success pipeline. We've to and these and branded address market an use excellent biosimilar. update UDENYCA, biosimilar our making with Humira in capabilities me marketing new believe similar taking will you to our markets. our commercial ability experience we penetrate We competitive aggregate

cases, each objective these UDENYCA, of in Our markets, with at even greater to take in as market some new is and share. least XX%

Bioeq report to FDA. biosimilar biosimilar CHS-XXX, the next launch our pleased I'm the BLA partner, submitted Lucentis recently that is candidate. Our expected our to

the approval XX-month filing for is and Assuming standard review, we review accepted anticipate a cycle.

Launch it product to in formation. the market, planning Lucentis will approval in actively XXXX and the the about among potential candidates first participating excited We be this believe is market are underway. of biosimilar

CHS-XXXX, biosimilar, XXXX FDA Humira that respect well, the date. for the target on-track is with December we to progressing application review our believe is and Now

United after in that to CHS-XXXX launch on States You or expect July may X, we recall the XXXX.

BLA, Regarding the CHS-XXX, a of our Once Avastin incremental line. first biosimilar, to our support capabilities study commercial UDENYCA which to commercial oncology base nearly three-way approved, identical part will margin toripalimab, in with file leverage expect we currently are we XXXX. opportunity conducting the as PK Avastin to our adding customer bottom further and

in you a make or NPC. and me a respect our provide let BLA Now, with update with toripalimab remarks filing to nasopharyngeal regarding positive few carcinoma

FDA to to concurrent supplemental evaluation potential JUPITER-XX, recall treatments. overall data, session thereby strategy and to may at XXXX. calls third-line the we ASCO. preliminary half first-line clinical time for continue to be data quarter, approval first-line second with you trial survival NPC in for NPC, this the accelerating NPC now this BLA filing the generated the strong first-line BLA evaluating expected indication. and BLA the registration agreed the and for June completed for project accept second submission post-approval the indications filing a As survival progression-free has first is toripalimab first-line all approval then presented for of were and that submission in the and rolling The third-line

continues of the also to be cell lung which survival, at to Phase study, XX% Medical at Phase we toripalimab neoadjuvant approximately III had PD-X met patients the conferences. Junshi III/B two pleased data studies toripalimab evaluate trials reported lung medical represents I'm cell positive and in for is endpoint XXXX. Data primary rapidly report Now, will lung and of progression-free which expected that free cancer study with and II first-line endpoints at Lung will overall the clinical cancer presented cancer, cell clinical market September co-primary with earlier squamous also Meeting and the World enrolled featured its from non-small be be of make is Annual expected endpoint data in met The at on readout small failed survival toripalimab esophageal Cancer. now fully with in JUPITER-XX lung Phase III in opportunity. additional which treatment small and EGFR Society co-primary will European year. survival, with carcinoma, progression-free of are good Conference of progress next TKI the in enrolling the cancer also to Phase presented progression overall Oncology. cell study

find today. studies website You these we posted of to on earlier which August details XX Presentation Slide of the Investor will

on I and lung Phase Beyond One first-line in immuno-oncology project the a hepatocellular the response that franchise neoadjuvant other XXXX, rate we strategy. for triple-negative trial, the also progressing of with carcinoma. detailed rights being Slide a our option key Investor of in TIGIT can the in part in of is Junshi now is well. antibody is a developing cancer have Phase JSXXX, which improve trials by is Presentation. and clinical setting, evaluated data market agents our the additional study I'll Access cancer over one the foundation combination color in Market of on XX Toripalimab the from Paul going as for UDENYCA. and two and treatment we turn now in for first-line forward Reider, treatment to our III and call Phase breast III Operations for Paul? some Vice see Commercial Executive of dynamics President we

Paul Reider

market quarter-to-quarter. pegfilgrastim share market. ended X% quarter approximately in pegfilgrastim quarter from share the Thank UDENYCA in the to for the with move from of trend X% Onpro, grew validating points, the primarily market of hospitals. This the came overall customers' segment you, and percentage XX% away decline Denny. we end The market the profitable X overall XXXX, willingness of expect continue. Since Neulasta to declined this XXXB UDENYCA least shares

for Going we for UDENYCA. of source forward, biosimilars despite pandemic, will especially growth for COVID the Onpro and taking share that believe be a

compared within share market half sales expect calls. projecting second quarter the half ASP of compared driven the the in redeployment are XXXX. We stability by and revenues, modest XXXX, growth second With to to field of to competitor our to ASPs the our respect teams first of third half we in-person

to However, there our major two control, difficult therefore largely are uncertainties beyond handicap. are that

market over on resurgence to it our available quickly the for access. is maximize erosion with sales either the level precipitated in McDavid is competitors. review financial opportunities. movement confident of our to and I'll force back First to We second And COVID remain our results. manage quarter's price turn to ability now growth, share respond dependent a challenge of the by impact

McDavid Stilwell

our filed the of in details financial are results and the we release The afternoon. press Paul. XX-Q this Thanks, in

now few a highlights. So I'll just on focus

second we the net the quarter for million a from flow $XX.X XXXX. second operating Cash of basis. loss reported negative activities GAAP $XXX,XXX on For quarter breakeven at XXXX, of essentially was

inventory prior quarter and prior inventory UDENYCA the quarter. approval. revenues as fully As was the sales detailed stable from UDENYCA call, Wholesaler of the in the we to increase million, goods net the end. net Cost quarter, the manufactured earlier to product increased was an revenue compared a in depleted the In from first million prior percentage quarter. prior in recorded $XX $XX net expensed of

was acquisition the fully within so with costs And reflected per period second first quarter unit COGS. the

similar gross in margin quarter. a and then the quarter fourth an expect in third the We improvement

to we in bring advance same we the to that XXXX, as period million royalty ago impacted with expenses was of Research of The four two balance year $XX.X ago the pipeline. primarily million the such a the the we realize to to the process for of of of million expense to regulatory to margins affairs full compensation compared common toripalimab purchased margins in equivalents Coherus and to was during of UDENYCA the and royalty expense million development activities expect $XX.X the transaction. the offset XX, benefits quarter. and which cash increase starting that $X with to and second And well which late-stage Biosciences securities associated the we recall reflects COVID of a cost for the from by a the expect XXXX. products for compared commercialization we gross $XXX.X activities, higher compared our expiration. ended compared increase general quarter purchasing XXXX licensing spring clinical The for Recall second or cash, million manufacturing a including market $XX.X $XXX.X accounting R&D mid-XXXX. XX% years, was heavily million quarter quarter and stock-based the administrative in Biosciences driven UDENYCA Junshi to $XX of the XXXX by stock Coherus higher expenses in of and Junshi in $XX.X million CHS-XXX. second were [stem] equity at as XXXX. as increased run, and CHS-XXXX, partially next lockdowns the trial we as for received owe March return XXXX. toripalimab in the the manufacturing investing year BLA In in million were the due For treatment XXXX, We a and long second to significant second year are up filings for by quarter. as through mid-single-digit development around gross improvement expect quarter, XX%, quarter by quarter, marketable credit Selling, additional of

$XXX payments the are year the Denny $XX expenses back excluding million, our $XXX I'll million quarter compensation million maintaining Junshi includes for Biosciences, guidance full turn R&D stock-based now and closing And to remarks. for SG&A this approximately $XX in million We to range to first of expense. to upfront and call

Dennis Lanfear

Thank much transition third launched on to currently colleagues a the States In filed you, thank are the plus diversified in approved products oncology. be United in one appreciated. multiple our BLA and work our to to approved two a progress XXXX, results from Coherus teammates to rapidly on have at advancing efforts company products product toripalimab. UDENYCA products biopharma team's closing, making we products four the of we is the my and generating in In over expect and for hard year. very with McDavid. Their five soon next I'd strong like process, to congratulate transformation revenue. We're objective to The the are on registration

milestones our Over turn biosimilars the to clinical now through line to months, our can and forward in look New quarter, we over we'll when York toripalimab. have City. regulatory the several data anticipate Thank We Operator, Analyst presentations next Day medical questions. fourth announcements, providing you. both updates the and we for event

Operator

line the Wainwright. Douglas line from Tsao Sir, of Instructions] H.C. is open. of [Operator question Our first your

Douglas Tsao

thanks questions. afternoon, the good taking for Hi

the a sort like terms curious what How of just take we're playing as through innovator the continues Denny makers It the of of perspective Just discount. seems starting do to biosimilar hear but pricing, that the seeing point to in out has your the of some see from in market. stabilized, you pricing sort balance UDENYCA year?

Dennis Lanfear

Hi, Paul, I'll that question Doug VP question. to like Reider, our Executive Yes, over for the Paul would of question. thanks that hand to you Marketing. address

Paul Reider

growth pushing the race market. only to originator the really biosimilar increased Yes competitors bottom from will Amgen published Yes, is lowest watching growth down. our and They standpoint, meaningful taking sustainable the not are ASP a share I strategy. in really from QX we biosimilars the over price need definitely the swapping a pricing come sure, from From ASP to that Denny. mean, in recognize has QX. the for X% And have among

So the the we see maximizing by highest originator, declines comparison while maintain to there. can the share. on the value remain you focused to long-term price and over ASP But

Douglas Tsao

some question, know another I - looking end approval launching year XXXX, see later? XX given commercial build-out a this the of for but And product? little Would maybe of we're we just likelihood then months point that you curious to at it's just what ahead said at to early, the just expect and

Dennis Lanfear

That's great a Doug. question,

we research indicating But are believe will market that access potential for market some be around primarily force. we sales that driven record the We the are a as payer-driven operation. on currently earlier structure performing

not So do commercialization substantial the side that see to on we product. increases support

increases, be substantial. Although, there probably will some not but marginal

Douglas Tsao

Okay.

few And before you're those that sort just stream would the given be be we a the on months of so would launch? not actual that just spending anticipate much, fact to going

Dennis Lanfear

our of product. actually, point, to describe substantial do boots that. decline ground to the the number a of the organization efforts support this expect, in on various places example, breadth to that put to of not I'll But move for at we

Operator

of from your of open. question Sir, line Mizuho. Next is line the Syed Salim

Salim Syed

- and on both I a from thanks the on UDENYCA. Great, one good can much so so question if actually for me afternoon, guys couple

So, look the even previously, share, the now higher share ASP up to a when ZIEXTENZO slightly little they starting a from pick bit it quickly have pegfilgrastim we data, like looks using. is more at more than though

on me points. if It that on the you second get more correct with dynamic wondering heroes, be do And from an summer be the it Just you the we assumption could to some a a there? of given or mean occur? you fall early get give and device, just or those from mentions Thank seem you. data suggest data et to to some that bit on-body the And to could with that able on-body only data there? approved should were cetera, clinical then color this us your little potentially what potentially for Is trials. expect does device, we if when trial the to biosimilar

Dennis Lanfear

- that Well, ZIEXTENZO to question, with second progress so to that the I'll that pleased that Salim. I the and on-body are product. I'll for with would Paul comments the the rather question first are thanks let respect take first, we think reiterate our and address we making previous respect on. With we device,

ZIEXTENZO moving But bit about decline UDENYCA. on over know, you is to you a delivering disclosed market? expenditures had the little and product probably for do for along. Paul, As the past we say for modalities have year want what's other And I'll in to some, give you think data. that going timelines I

Paul Reider

here our going we're profitable a us. to we're entrants now. pick points of biosimilar seeing that share the their of of got gain to It's Coherus, the to which Onpro. It's the share XXXB that over primarily It's Hey from sure. likely share reiterate for least Salim, XX% up for I'm is at market. any focus segment. Yes, going couple new coming segment is is from What

some focus where So is share It's share really in we're the short our Onpro, that's long-term. gains. seeing take market both to and for been

Operator

question of The Schott from the JPMorgan. Chris line next of

open. Your line is

Chris Schott

for much the so thanks Great, questions.

UDENYCA and this. one. sorry I UDENYCA, on if On a bigger - picture misheard Just then think one I

the time, in about seems there peers of opportunities, going to more relative I stability I-O bit? didn't guess, I you building be lot dynamic, As actually dynamic maybe know, talked then you in remarks, market. basis? competitive the to absolute I that think but think broader out forward. that question, the a starting the going or about over also picture on an a driving is, oncology you've to expected think seeing mix normalize that is I I of forward the some During price or ASP bigger portfolio prepared space And are is stable my

oncology the obviously me very well be guess, mix of ex-U.S. focus large in would there's the non on any too or assets that So There know be at kind look there the just developed be there? company some as I-O there number interest assets? assets Thank the I much being very add, and a to as of strategy seems specific I-O is to spaces is, to that to you well. And something what is you. could

Dennis Lanfear

you the Chris. question, Thank for

first. question ASP the take me Let

good As our ASP try that. in think our as record motivations be reflects control to you we modest behavior we know, being of so That decrease our I We keep competitors other And price consider pricing market, and ASP. prices, possible. the their to of our record said, ourselves and guardians regardless on. can't as track the of

think Junshi you that up few engineered forward, products somewhat might are over bring a the But to very IL-X, the as be our et respect the decreases have TIGIT, With a several quarters cetera. We I required. there and We with this stable course, immuno-oncology ASP interesting looking changes products, for oncology in currently point. currently collaboration, future, quarter. came with additional of

overtures, But to with are toripalimab, Our I focus in think use partnered amount our for toripalimab. overtures with assets is on fair that cancer getting a the incoming to we it's PD-X, say now various cycle. immunity fair conjunction of

for into us XXXX. the think the out look fair Junshi of year But end open-minded and that as - of is and we reads center the that that I So, data at. assets say I also TIGIT would we remain to say about front that sort

the interest. PD-X our seeing causing entry We significant with is market though significant are into - the

Operator

of from Next Gerberry of Bank America. Jason Sir, line question of line is your open. [Operator Instructions]

Unidentified Analyst

This for is Ashwin on Jason.

So I two, is Humira. one have on

competitors, expect that's looks to first XX% assumption we've so should XX% for for for it on jumps And any it and predicated the share recently? XXXX So think one. in you level seen around and same XXXX two you first one, the say the like AbbVie projected is expect So either interchangeable gross on interchangeable I saying Thanks. second XXXX? just that to biosimilar, they extent biosimilars. now approval before what that, in getting around your is And we XXXX XX% the two margin biosimilar or

Dennis Lanfear

issue. McDavid the voice don't margin it's speak gross I'll We I'll your segmentation for the of Humira. interchangeability Thanks for payers take in significant We interchangeability your of them. of question. loudest as lack that a question. probably of let of think selection market to is choice penetration. impediment biosimilar more believe for we've a have we to with of the issue said the the that previously, the And apps will terms believe

we biosimilar So for at we are reason the adept market, to very forward which raise Humira market is why think to we XX% do well very, the projecting competitors. look that consider the that. share in very we And of will And be ourselves post we entry. biosimilar

with to I'll so McDavid, let your that. on McDavid? questions Now of address gross on, margins and respect to

McDavid Stilwell

Ash. thanks, Yes,

in quarter the remarks, which we was said unit as UDENYCA first acquisition the So cost full in of the per prepared realized. second was period the

separate utilizing or would improvement. the the will I And were to second third the a there though as were element we in were process of that increase quarter was was UDENYCA. quarter, the to it That in the quarters price manufactured also lots second mostly cost in goods net that net lots the so obvious be and third and and a for available prior in of add that actual percent of sales. responsible a the that

to fourth were relatively so, the that of more quarter lots. through from quarter lots lots And and by down low-yielding and And stable the to those point expensive we actually back margin be XXXX. then XXXX and, move gross those in relatively expect the to therefore, and end through third for come

that trajectory for we goods. the that's So of expect cost

Operator

There questions. Instructions] further continue. no please are [Operator Presenters,

Dennis Lanfear

providing Again, thank our you much in and Thank in at us next look with we update much. Day Thank seeing to joining look you quarterly you. you for We QX. New very another today. York very forward you our on forward to Investor call,

Operator

concludes Thank participating. today's everyone That for conference call. you

You may all now disconnect.

Coherus BioSciences (CHRS) 8 Aug 212021 Q2 Earnings call transcript