NVO - Earnings call transcript Q4 2021

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Operator

Hello. And welcome to the Q4 2021 Novo Nordisk AS Earnings Conference Call. Throughout the call, all participants will be in listen-only mode. And afterwards, there will be a question-and-answer session. Today, I'm pleased to present Lars Jorgensen. your with ahead go meeting. Please

Lars Jorgensen

the unless this will release made The Nordisk's session available that about is turn of the much. Thank minutes. this be Strategy outlined constant Head Please website. Executive have Earnings for and Executive earnings of Please and rates Lange; to Slide X. this statements The Nordisk. are and Chief Executive Norgensen, Nordisk available Vice specified. one President of Affairs, to hour. for sales our novonordisk.com. structured live, for webcast you Development, and XXXX. presenters me Head Wulff; Vice that be Holst Product Vice scheduled Langa; call in recording being will the Commercial Please Q&A is Doug slides and I Henrik Lars Executive the North Supply, and profit Please call Head outlook Corporate website, and Today's Operations, very call at and Vice a full Financial Novo XXXX Camilla slide. of presentation Munk made Novo all call to Head on note Welcome note President year Martin to Officer, will today, be President America on last available and X. of Slide Knudsen. exchange as will operating the CEO The begin Q&A otherwise President next finally, Novo growth session. on for and I'm Karsten With turn of Sylvest; All is XX

Such contain are differ materially that call will advise forward-looking and could to from cause I this risks to always, forward-looking need to expectations. results that uncertainties you statements actual As subject conference statements.

next responsibility the these would highlight Affordability this Novo of on sales programs. slide. risk XX% received XXXX, of few take Please social turn From please environmental to Access and we million the treatment Within like emissions of for today. reached on full our million progressed. focus for and also XXXX, to the operations by prepared For to X people see to presentation. transportation almost across aspirations. through growth Defeat the announcement a double-digit and further information X sustainability, slides delivered factors, progress we with on perspective, all XXXX. impact our than year In a our In continue an dimensions action and and access Nordisk XXXX, company Diabetes, prevention. I on our the strategic decreased purpose and our have COX treatments. with we strategy, living diabetes with In More compared XX XXXX

environment, had we aspiration. perspectives. offer underline interesting within gender across XXXX, will areas. a diversity the we milestones share R&D pipeline. our from therapy gender purpose working and our to will global all to of commitment by diverse The levels inclusive Finally, back to Martin end a come of this balanced representation the XXXX. material is an to launched Phase exciting to ongoing end briefly specific readouts but key our like clinical multiple the R&D, with all my would an overall By within year III trials I be of XXXX achieve

with platforms. all platforms therapy technology range RNA its is we across interferon complementary RNA Novo a and existing Nordisk's The interferon Following acquisition our supports technology of using Boston-based Pharmaceuticals platform since in of productive our XXXX, areas. technology partnership Dicerna a Dicerna platform strategy acquired broad XXXX.

sales well We execution reflecting biopharm. growth, start obesity across expect the we diabetes, with XXXX, delivered as across commercial clinical geographies In first to development and XXXX. in as double-digit solid half

by covered Doug. across progress Wegovy, supply for update will an situation all Henrik later. commercial provide be The and the Camilla therapy will Regarding areas

constant Lastly, for to in to XXXX, - With I profit operating measured pleased on commercial sales of growth at and with an the rates. update leaving execution. both word of over XX% XX% Camilla the we financial exchange Knudsen are growth that, give

Camilla Sylvest

market operations X the been Tier in sales areas. sales International driven increased turn gains with and overall reaching America in driven In year of in points grew of next now Esperoct XX%. gains slide. by third growth ago. geographies to units. A XX.X%. growth was Nordisk And by total and partially GLP-X sales Currently, X%, X% XX%, growth America XX% flex in operations. blood by Insulin Please The Novo Please care market. grew driven increase in operating Obesity by Saxenda sales international of grew growth care America and XX% XX%. our XX%. XX.X%, across as And and Operations, share countries units in Biopharm XXXX. by XX% in X% and also uptake to operations In in in within Specifically, XXXX. and NovoSeven GLP-X sales growing care and X. XX%. X%, XX sales operations Ozempic growth X% we U.S., for This Obesity of Lars. and And growing the by now sales declined In with X%, in full a In turn growing hemophilia overall. increased by operations decline sales with sales North NovoEight by operations endocrine by X.X turn driven sales by America share declined disorders Biopharm XX% X%, XXXX, prices Slide increased has of launch overall diabetes by America by market and U.S. North XX% realized diabetes sales over Rybelsus the Slide increase a by market Rare GLP-X year Obesity on Henrik North launched decline operations X. X%. operating increased please growing increase lower driven decreasing an of driven sales by both driven operations by NovoSeven driven volume. diabetes share by North market In as sales X%, to to Saxenda and you, by international just this international offset X% share X% to our compared percentage by the both International grew in in supply reflecting XX sales one and update offset and operations disorders sales by and points of XX% X%. by remains of aspirations of North Rare sales Thank Please Thereby, a XX% by reflected geographies in X%. of and is the the share grew a Operations, international products faster Slide XXXX, to XX%, diabetes in international grew in growing operations. our Refixia by sales line well X.X The XX% strategic X% by by by products, by North by operations for GLP-X the XX%, operations to XX%, by was increased increased Wegovy. percentage value This hemophilia sales leader improved growth X. have [indiscernible] North B countries. sales situation XX% The by driven international international now driven decline XX%. insulin than grew care market all operations, therapy X operations update. America our America by XXXX, and is both increasing sales turn growing care

Henrik Wulff

next the slide. Thank turn you, Camilla. to Please

in on while track I provide capacity Wegovy, the done Wegovy start in latest assembly for on half improvement Put compared of In recapping script and XXX pharmaceutical the temporarily would were correct optimize syringas. ramp the Wegovy deliveries now that This worked Following like the to we to Therefore, addressing the our first the contract hard capacity meet you to XX% market compliance close of CMO weekly by Novo to stop produces as to capacity. the up a a an the the December the XXXX, filling we U.S. up with U.S. and expectations. issues. to the XX% to Since in and total site to at letter situation. our conference supply is had U.S. for I the would - the thus FDA, close of demand internal update the by the like Consequently, ingredients CMO, call packaging the Unfortunately, 'XX now formulation from previous manufacturing Wegovy received with we simply, Nordisk capacity and in production know, as an organization. seen on around the and our have active communicated range. is issues situation you will in 'XX. be and cGMP in-house XX,XXX internal demand manufacturing large collaboration expect CMO end December, now for for to

resume to PDSXXX CMO meet platforms to With of in to half would and flexibility U.S., While Wegovy collaboration a expect future be U.S. to existing in half has launches. Outside European will the submitted 'XX. X Doug. decision production, additional for will in the 'XX. a the over and Working place we provide hand have platform for I second review And with we Union. of regulatory that already still expect like progress the in have of see for yet constructive the able good we demand second the that,

Doug Langa

ensure has per sales and of unchanged. and expect we prescriptions Wegovy class. launch starts week scripts market. very fewer access. time with the has of XX% continues marketing like And Please the issues can escalate put quarter we Market is access XX% Henrik reached Henrik prescribers less the XX,XXX we possible. branded launch And Wegovy care X supply anti-obesity activated. co-pay can record the the X unmet challenges, cards months, in and of and patient Saxenda the are long-term we and people have than from anti-obesity sales Wegovy than be hold is of the activities expanding with XX% sales year. has XX% illustrated fourth do the to to everything been Wegovy XXXX. there to significant remain doses. feedback for more still potential for around to Wegovy new have each go on weekly the you, since medication last the the progressed Thereby, Since Currently, American is resolve sufficient Wegovy to need can to supply growth Globally, doing obesity. international fast increased operations. as And launched patients longer are be slide. for next And Consequently, have to of year-end, with by North The in supply combined marketing through that no as U.S. until as Obesity operations mentioned, pause Thank of patients compared of that we in update. new encouraging. the confident activities, Despite

importantly of growth access all now QX comparing major turn volume next for XXXX continued as uptake is as Rybelsus. than of XXXX. Specifically, to includes more once Wegovy Ozempic commercial of to is formulary and XX% weekly XX%, PBMs. share slide. GLP-Xs is market of Novo driven new-to-brand Please The leadership injectable is GLP-X QX U.S. Rybelsus. and the driven the And around the market now well XX.X%, Nordisk's this by by

progressing second rollout In remains U.S. Ozempic launch. leader, continues to since COVID-XX above contributor been the share. Nordisk of to clinical growth at Measured currently trajectory its and positioning GLP-Xs. in remains early the largest Please In NBRx and Nordisk, despite within XXXX, countries. per turn XX,XXX XX type is Rybelsus's increase, Slide impact on leader injectable the X Novo the global total market treatment with than cascade. in Rybelsus more with scripts, launched steadily Rybelsus XX% share week total has in the the Importantly, now to XX. was share market from diabetes attractive well The profile prescription Novo prescriptions market

X of by is product. the key We remain of in increases markets the Outside potential the in U.S., are the weekly Japan. the confident encouraged breadth and

In Rybelsus limitation the and in 'XX, modern prescription had in was now XX-day December Rybelsus anti-diabetic a performance. that X.X% Recall seen a the jump X.X% lifted, market. of value have reached has reached share. market oral already a share of Japan in Here, we MOAD in XXXX, value QX

on for Martin update to over R&D. Now an

Martin Lange

Please XX. Doug. Slide turn Thank you, to

Within XXXX Our space. X on quarter R&D milestones biopharm, the fourth in year. a exciting the the reached we ended during note high of

completion approval XXX regulatory successful Norditropin. non-inferiority once-daily The Sogroya the Phase Sogroya the hormone for deficiency the primary III submit was children with a first XX-week trial to The trial first of children for expectation high half from compared once is The 'XX. of in treatment Sogroya, weekly suffering hormone for growth of during growth in met the deficiency. endpoint with velocity the of

second proof-of-concept the from as trial, completion of pharmacodynamic In successful properties appeared Phase part The ongoing first trials once dosing. and ascendant cohort milestone of supporting well the tolerated, the MimX. well safe dose and the was multiple monthly the MimX both once I/II clinical weekly as pharmacokinetic

For the as active treatment of Phase the second 'XX. And upcoming III results in of an details further share both MimX trial, initiated to 'XX. at of I/II pivotal III program the was initiation plan Phase in We well as expect quarter the fourth half one we the Phase on event.

once Phase milligram combined a we is combination people raising bar have X line aspiration expected enroll in the all insulin with of in the The weekly trials related the IIIa treatment, X global with to initiated Icodec. our strategic total, and of for semaglutide further program X diabetes and Finally, X,XXX Icosema, type diabetes. first innovation of for in program

The people profiles X initiated Icosema offer with Phase Icosema control. diabetes. treatment III, will is versus type is a attractive combined type approximately and basal as data versus insulin-based superior convenience weight patients to expected treatment entire as that combined complete dramatically well Furthermore, versus it X during The bolus is XXXX. hypoglycemia first in free, trial insulin motor diabetes. which will XXX once components glycemia in In it bolus on XX-week similar with expected improved of the to program with and efficacy combined trial, a weekly safety as efficacy be investigating show

next slide. Now please the to turn

many Turning high-level R&D year with to XXXX areas. our a across readouts the milestones, therapy is exciting trial

the I the treatment A fourth a X decision with approved 'XX. of X the milligram semaglutide the type cover. the with superior semaglutide XX treated FORTE milligram. half diabetes the touch reduction from compared trial, before diabetes, is results I of However, for achieved get on that, first semaglutide SUSTAIN milestones 'XX upon people to at AXC in of trial. from that expected to did in X and like quarter In significant to would Within I milligram as the weeks based EU X in not during adults was statistically U.S.

we fixed glycemic X to placebo and with addition, XX-week of as analog In dose combination a on trial type of X semaglutide and II comparing the semaglutide once-weekly effect people milligram weight a initiated well a diabetes. control Phase compared GIP of in body as

Now turning XXXX. to

clinical 'XX. was of we diabetes, expect the first 'XX. 'XX. to from the This Within we milestones Icodec in biopharm, Phase Karsten treatment of milestone EU cardiomyopathy. and short expect with with We people additional R&D Concizumab the obesity results second like prioritize we ongoing also many of initiate IIa expect to ongoing of by Phase X the would asset for to for during 'XX. living trial half with IIIa 'XX reached approval few term highlighting trial Wegovy initiation Phase an the the important obesity on with to of Phase Cagrisema to finally, type production With I Phase results Cagrisema to be ATTR EU. addressing for II internal in IIIa a the based the Europe. need Prothena over program with trial with the of II in the And Wegovy, IIIa the acquired first end diabetes. postponed Wegovy look will a in And PRXXXX from the available trials also half capacity Within you half unmet making the We from program, people for to Phase expected during obesity thus that forward the STEP that, trial we significant in for

Karsten Knudsen

Free increased partially operational Martin. by In currency activities lower improvements and exchange and to lower showed rates. pipeline Danish the NASH. an Sales by a turn was exchange related hedge kroner XX% billion Danish Ozempic the low XX.X% exchange in and kroner priorities, impact by product and constant aspiration Administration by rates. points, of compared XXXX cash percentage including in you, to Technologies in The rates. in impact next margin in compared The XXXX XXXX diluted billion kroner increased XXXX. driving XXXX. amortization to is gains DKKXX.X cardiovascular productivity This a The kroner to XXXX. pipeline intangible acquisitions exchange flow X.X increase and around to constant in constant compared by gross by the per mainly to billion to costs These exchange DKKXX.XX. and the in was U.S. launch at XX% related for by Danish Thank dollar. acquisition Please XXXX. in rate Net of declined tax The DKKXXX progression kroner disease slide. DKKXX.X partially costs a items XX% The and U.S. increase net costs of development for working obesity. Operating and promotional from by Net to distribution diversification, and sales driven are development DKKX of tax in sales positive in and increased changed by a gain and program. efficiencies. driven Emisphere for XX.X% increased to million loss of earnings by by Danish at spend currencies due for offset the effective financial driven for the a strategic with of profit line strategic in is COVID-XX. countered with U.S., negative to capital. effective in by within reflects higher Danish 'XX changes of GLP-X constant in assets spend the primarily by XXXB by reflects The by Rybelsus XX.X%. and prices spend in at XXXX, non-recurring higher increase investments compared constant distribution XXXX. XX% mix, The increase increased of on XX% grew This rate offset relate and at key XX% by most impacted in XX.X% profit driven impact notably is in rebates Research decline rates, X% a promotional rates. profit realized increased as in and driven is XX% our market X% partially insulin. policy and by The XX% as the unfavorable and at from provisions X% expansion well activities share is XX%

Next shareholders. slide, will to a of In from March a Directors Nordisk XXXX, XX, Meeting dividend and final billion of Novo of approximately propose increase form At in General DKKX.XX for dividend XXXX total dividends the please. returned DKKXX Board Annual the a buybacks of share the XXXX. XX.X% on 'XX, DKKXX.XX,

was billion In for consecutive to Novo share buybacks dividend, returns increasing DKKXX for years. and investors addition used with free flow XX cash repurchase dividends, per it's dividends the shares. the Nordisk to of share consistently through

a XX. XXXX. go solid development We transactions expect constant of billion of DKKXX guidance business to be XXXX program rates. For exchange approved the in be to and The significant sales to at up case second Operations momentum North XX% months. during growth obesity the share meeting program of may XX diabetes X% The both reduced driven to in growth Board and reflects but Please new the between reflects and XXXX, repurchase U.S. America both it's XXXX. for total has size Slide the be as the Directors within Within a in of insulin an demand executed coming with care, impact and during competition therapy biopharma of half expectation and from the across also in procurement growth guidance obesity well of diabetes operations by care. International sales in volume-based for expectations a care China. negative and in intensifying mainly areas, It Wegovy as reflects enter

by would group points in percentage VBP called X We sales negatively impact China XXXX. out have previously that in

growth future and late-stage of being between is resources the Finally, U.S. continued launch investments. diabetes the expected impact market outlook in of reflecting to are Furthermore, allocated in development drivers. both X%, X% and and to sales the grow Operating within growth early the especially and continued pricing development. the current rollout continued R&D and to This and pressure profit additional pipeline includes sales Ozempic care, investments Rybelsus, expected activities. Wegovy is associated negatively

is profit growth Specifically, impacting the of X by points. negatively percentage Dicerna acquisition Pharmaceuticals around operating

net impact net and the current sales operating rates, increasing around our foreign billion and are now rates, DKKX.X loss than items be strengthening notably is increase expect exchange items for X progress. expenditure at Consequently, be in additional by hedging a partially X Capital reflecting in is expected respectively. with percentage mainly to to around offset of and associated now reflecting Given investments financial higher manufacturing exchange on points XXXX DKKXX financial on contracts. of to U.S. currency to expected dollar, active the we billion, exchange for existing profit losses a at constant profit sites, most currency pipeline the be is growth expected XXXX. operating demand positive relates expected pharmaceutical mainly ingredient a impact positive capacity The reported The loss 'XX.

billion. 'XX cash the Dicerna between reflects XXXX. The the Lastly, expected of major impact is updated potential increase 'XX. DKKXX development That DKKXX business the million acquisition to to outlook and excluding Pharmaceuticals free be compared in activities flow, for covers from

you remarks. Now final back for to Lars,

Lars Jorgensen

Thank Please to the you, turn Karsten. slide. final

diabetes obesity growth the geographical sales We we and was This International well growth are sales reach driven to patients. Operations by America And driven areas. and double-digit by care. portfolio growth with even all therapy In very North was by more within in as particular, an XXXX. of growth continue GLP-X treatments as areas operations our of accelerated for pleased all

usual, CMD other growth beyond on semaglutide Day upcoming be our outlook that this with XXXX at to strategic in and our At and would Copenhagen. our the like I will we're on kindly Capital hope focus management Finally, to executives ready held to March and be the limit senior executive The day the remind for of headquarters as present. full the will X you will person. Markets event, many of take now to questions. or himself event But of you see in participants ready be webcasted to live. set all one maximum that, Operator, We first or also now ask will With her aspirations. Q&A. questions. two we're I

Operator

question And comes Wimal line Please the from the first from of Kapadia Bernstein. ahead. go

Wimal Kapadia

Thanks Kapadia my for question. very Wimal much from taking Bernstein.

can internal I XH ask just So some Clearly, capacity for from batches first supply. been movements both Wegovy some additional on and there's CMO. positive released from the

able question the additional really device. on the internationally. new is in your or and more for that larger the have filed of be you what supply And and U.S. from means if internal for supply, in the tied you i.e., my So then be so, that, do XH to just regardless may conviction that can to CMOs question quantify? is on the what Wegovy Catalent changed use to capacity, on Has supply extent second really supply brought a EU the impact views perspective, just broadly potential increase ex And Catalent? [ph] And to possible reimbursement. on on any potential board my that FlexTouch your supply

unaffected? at Saxenda. have Would your Thank flagged or inability supply you similar a by the you. access So coverage opt-ins point had these Curious greater superior been if supply been have if volumes? are discussions to the negotiations has Wegovy to impacted you and this to

Lars Jorgensen

Wimal. you, Thank Okay.

there, it sneak to I to managed cover think try anyhow. have we'll in. X I but questions you

there's really a bit Doug, because reimbursement we've first of ramping we ramping wants we Henrik talk building. maybe like internally and talks a to we to then supply much? then impact where FlexTouch on are Camilla, But events that done on up to any the is can And bit look So can supply. situation, changed global then the you has the here. are if to the you And up? how what And flexibility talk been at how

Henrik Wulff

Thank the Thank questions. Sure. for Lars. you, you

able capacity. hold that of of our So I so the our as capacity, first limitation are that we we have the internal stated, to of out capacity all, and on demand reshuffled is that 'XX, internal

be And restart second 'XX demand then, chain. building facility. this will from We the the on, following in U.S. with continue there the the in of will half supply we CMO back in

as supply will it mature stable as be our chains. So and other

plan unchanged what compared basically it's So to communicated December. we in

Lars Jorgensen

we're Am thank there? you. the I Camilla optionality confident building? on Good, FlexTouch

Camilla Sylvest

Yeah.

building just the right to the on of XXXX. we operations optionality, we And So the to is that increased make half now, have we flexibility initiate the being plans FlexTouch expect launch are Wegovy. in developed, our launches of international sure second rollout and for first are

of So part. much we that look forward to very course,

that's international we think are I in why So now operations.

Lars Jorgensen

was it on think I And question also a U.S.

So we for And have situation and believe we the we'll have that. with on U.S., press supply there. we'll robust right setup think we

there change reason then to course. the no any? So of on And if Doug, reimbursement impact,

Doug Langa

if to than commercial have. major that put to faster Yeah. our Ozempic with into not impacted PBMs. has to achieved was we Thanks, And Wimal. more have access. XX% was all We're that And may in just payer we certainly And that reiterate, dealing or it access with any a than compare concerns that context, Rybelsus. that access business

access now. right with of level pleased very we're the So

Wimal Kapadia

you. Thank

Lars Jorgensen

set Next question, please? of

Operator

Please The the ahead. Leuchten of from go UBS. Michael comes line next from question

Michael Leuchten

Karsten. Two think much. so Thanks both questions, I please, for

question Wegovy rest the past. there's second left again lighter the past. of wondering the Just longer guidance, wider bit just then the a around have timing, would style is that the margin in And you've term it just in word I'm done the would guessing maybe else this driven but than something little trajectory. about biggest than time have you if

cost in at sales. your OpEx it Danish for like you're excluding looking looks increase of guidance Just high XXXX, pointing billion towards single-digit a

help fits us margin make single-digit half, could it's once of really increments, sort you second in high going. have where for would a of quite OpEx easily Given trajectory? can with I year aspirations how term gets flattish Wegovy your billion Wegovy the it comes thought longer that up understand

that So still flattish? does trajectory will Thank and hold you. flattish margin components the keep sort are that what it of

Lars Jorgensen

Michael. you, Thank

margins on maintenance So questions perspectives OpEx. rest to of the on two linked asking

Karsten Knudsen

Yeah. Thank of you, Michael, for that questions. set

is hear in confident And of Nordisk Wegovy, we should in flexibility range some guidance Henrik, guidance seen not of need can back what course plans. course, our you still as previous say exactly uncertainty. could But as to But not you guidance, our out it's unusual for. on we if years, in Novo range yes, go first you've you time. So pan on are our leave planned in from compared to some there's

So outlook volatility that, more I we that demand But learned of apart in we're is XXXX as it's would say usual. the from also business facing. from there course,

we accurate, volatility We reflects are upgrading think it old is but in X higher more I be to and it than that want the days. times last also was year,

shown pipeline. expanding invest then continuing in results building - driving R&D, your margins, top-line to Markets the delivering. in to that we we're diversifying you and the that growth question is at then that late way 'XX broadly shown platforms we're is numbers We've are should OpEx and that the top-line. to stick with And have of we've off unchanged Day so launched our margin you Capital our operating reconcile the our I we 'XX. future answer in in aggressive yes, 'XX really agree, paid And hope I - As all, short our basically investments R&D on first

mitigated of negative you guidance. our in impact 'XX dip the as in guidance, as we've from OP see already Dicerna. Dicerna. related we And X% X% X% the actually saying in are to is And our So on can

on. diligently that something we're working that's So

Lars Jorgensen

Karsten. Thank Thank you, Michael. you,

Next of set please? questions

Operator

Jain question ahead. Bank of of the comes Sachin Please America. next from go from The line

Sachin Jain

please. Thanks Hi, taking Sachin Jain. for questions. there. Two, my

a guidance on just cash for then secondly follow-up for First, Henrik the XXX. and flow

growth that commentary normalization the I necessarily Just growth a scenario to guide? is you And just still guidance not Wegovy expect in to clarify clarify on wanted supply. of commentary the is GLP-X yet? rate, as the which visible Do what costing included on your

to So bottom to you the there's Wegovy Or bottom just just scenario? in guide have supply a then a where of meet clear you Does on the end XH. Henrik. supply to assumptions to resuming? what's expected resume and that as to are on not Thank stating whatever for would what I'm confident And you. today? you've lines close XH? time get be time XH visibility want no as before the to for got a curve, the for in the And allow scenario are you resumption? to is trying just way freight to packing clear, there's demand that demand it as on included you how be of with I include production assembly, then sense be end guide production

Lars Jorgensen

can scenarios. you, Thank first on how clarity know guidance Sachin. Karsten, the growth GLP-X I much on that? and you the bring don't

Karsten Knudsen

Yeah, absolutely.

market also, XX%. growth But historically. the growth So see tune art market forecasting the than of science. scale the the say, is global And I'd is as an growth GLP-X more in data taking we're available at looking data externally on can to a share. you market market a

expect a a market So of really, scripts. of more kind say, GLP-X few I But - normalization And would in was more our course, months. to related we I'd in into growth really more where franchise. there rapid QX early we the a the continue very over seen months in since total growth ago attractive of My nonrecurring GLP-X XXXX. comment TRx QX, to in pattern saw stable X step-up a we've say U.S. was step-up

So guidance that And then half is been the relaunch the normalization to. in I've the XXXX. basically built in guidance versus Wegovy talking the on U.S. was second Wegovy, of

Lars Jorgensen

then products and when and manufacturing, Henrik say on be will expect Thank restart And Karsten. of we - market linked to the in you, that?

Henrik Wulff

Yeah.

stock. time presented, also want capacities. slide pack of my the operational to internal our it's clear and in a And devices to of need that course, back we, level So we certain assembly

as to U.S. quite output logical that and this CMO from we the quarter year. - we follow be then demand 'XX, the second of in it in half the second are need in of will So planning

Lars Jorgensen

Thank Henrik. Good. Thank you, Sachin. you,

set Next of questions please?

Operator

The comes from the Richard next from question line of JPMorgan. ahead. Please go Vosser

Richard Vosser

that as 'XX? trials maybe think launch now been some But should you whether movements of could On Hi. were is maybe VBP? it second year? for Have Can commercial And questions. of in Obviously, on we anticipate my think think numbers, up? just issues Thanks can of have we we important NovoLog shape ahead And delays. we about those about the VBP quarter. in Whether a the there in prioritizing there in to soon inventory question, Cagrisema? - some then how the as taking the - and thoughts ramping so QX? like any talk I those manufacturing, your fourth some solved Cagrisema this And about of should should So pen you those Cagrisema from on throughout implementation was think destocking there just launch. looks you about manufacturing Insulin the NovoMix very was talk Levemir, with Thanks for China, VBP with Cagrisema. in in much.

Lars Jorgensen

you, Thank China, VBP. Karsten, any on stocking? Richard. first

Karsten Knudsen

you to of X% that So numbers that shipments volatility at basis. Chinese should look with products licenses on having distributors quarter. be and I'm the between import you be sure on different so There are used the confounding growth numbers, some quarterly whatever number When China a to to in alluded the you a factors on. the

And So supply along. wholesalers we've done there's no wholesalers. to products we destocking continue to with as insulin our all

Lars Jorgensen

your small Karsten. in comment to and supply. And on you, about of that Cagrisema Thank a initiation prioritize delay

our We pipeline And I pleased there's products with in are of and tremendous opportunity. both a really obesity. portfolio think

when So device. while as can delay this that's a to you guide we And something we on regard program? don't bit clinical bit Martin, the But launch talk think the a I on really perspective we products significant. don't trial

Martin Lange

pipeline great a Lars just in very our obviously important still Absolutely, see what with product said. as reflecting We potential. Cagrisema

said, ready device, is Specifically be half with basically Wegovy prioritizing but new that kept. second overall are on will we weight my of it that the be will until the being for clinical it's time towards lines current device. no that obviously, of tasked supplied trials. sort 'XX are we look the device, therefore, we delay. obviously, team and And now a with And our will That still we maintain production. overall securing And

Lars Jorgensen

Thank Martin. you, you, Richard. Thank

questions, of set Next please?

Operator

Baker next the question from of go ahead. comes Please from Simon Redburn. line The

Simon Baker

taking if I you may. questions. my Two, Thank for

sure should are I'm manufacturer or up question to, far you cropped either Wegovy Firstly, be any the potentially the compensation contract not received further that is there entitled issue. have delays. on before so potential about any

situation related just some on in there? if to secondly, quarter, somewhat assume and fourth the the and that And give color were So distribution yet expected. from costs I sales then some wondering the you and with offset sales could costs there on distribution delayed we've activity was launch Wegovy us higher than

if us in you sales of that on XXXX? could means a and little offset so give for much. Thank if there? distribution you of bit just And what an there was levels So color

Lars Jorgensen

Thank Good. Simon. you,

Wegovy are have a collaboration the CMO despite issue, they in we good on confident they the and the say, with we a situation. or very what making not do any on are think And We significant compensation So CMO. competent unfortunate like. bet the

a are the in also that partnership Karsten, the have delay? good linked S&D we we long-term. on in for So strategic investing to QX

Karsten Knudsen

Yeah.

with So timing ready been it delay bad our to training really and because reps then just was being the roll. we've

preparations really So spent QX. was what we in since vis-à-vis in were reality, of planned pending. spend to have launch Wegovy it launch a we offsets We didn't the any lot

in learned very, was Wegovy the that supply very any impacted which also in about significant we by December. late the So I not, QX said spending form, situation,

and continuation diabetes our a drive just investing on global to obesity our is of spending in GLP-X growth. scale a franchise QX our So

Lars Jorgensen

you, Next questions, Thank you, Simon, Karsten. please? Thank

Operator

question next Please go The the comes Verdult Peter Citi. from ahead. of from line

Peter Verdult

questions Also on for Martin R&D. you. Thank two

next. into How that year could from about strategy Just read of on then R&D going these hearing of and [ph] And out Alpha-X this actually KOL secondly, your we're and checks the sort should at Flow we Sole HBV think early programs. the Dicerna alcohol very portfolio or forward? end fitting and used to

with when the because us year to that see based expect Just interim the on event rate this an on Can wanted that check And you're you SELECT. us just perhaps of in you surprised trial? to sort to that on upside. readout then seeing you remind

Lars Jorgensen

Thank Martin? exciting questions, you, Two Pete.

Martin Lange

on very that looking are individual interesting pipeline, to Thanks but specifically them. and early a still assets obviously progress Pete. see questions. Two the it's On you'll abuse - your how lot, alcohol evaluating days Dicerna and the we at and

for With are Specifically, submission year. regards upside go first, to two into details. to endorsement But beyond that and have per Sole to obviously early out it's trials, not an plan as of this the this later and probably you we We [ph] towards monitoring our - to regulatory we too read early to extent Flow are know going we progress the that all I outcomes that, situation. hope will readouts. disappoint year.

are event anticipated, interim will place. rate we we that we the to situation, We and course monitoring have run course the will what SELECT, inform And still if take means not have seen story. the and an than lower neither basically we and that of on higher nor when

Lars Jorgensen

Thank you, Martin. Thanks, Pete.

of please? questions, set Next

Operator

Paribas. Next comes from of Mather Simon line question from Please the go BNP ahead.

Simon Mather

you Thank for taking questions.

with component, bit and then a semaglutide just II that maybe discuss trial. just secondly, respect probably Can it exploring? doses in you're clarification tirzepatide fend one the that much, the respect change increases to this your one And much a importance? for that the it's if between And kicked that a of more just question. a guidance lower not, the little kick one the Phase can with yet the if the top of hit Thank in Is Martin, the expect driving you the bit we of if the more sema just obviously, on of first of product end - wider off in dose off? clearly is The it BBP, factors thinking on year, likely delays X-mg range therefore, is had few guide? Karsten, to to you're Richard's to arguably maybe and just actually sema of you GIP to hasn't comment when you. and should the - of importance and off

Lars Jorgensen

Thank you, Simon.

Karsten, First, timing VBP? on of

Karsten Knudsen

Yeah.

informed should expect of an timing we've VBP, been implementation from we So that May.

of if the I guidance of terms plus/minus the a volumes course, And the of hospitals don't in allocated and our their in say so of different But that marketplace impacted between that's implementation it's is VBP exact impacts substantially guidance volumes free are assumption. manufacturers. wouldn't it know working or some so. how of month will use how And we the

specific uncertainty course, of from entails terms the VBP. impact of that, So in some

Lars Jorgensen

doses? design semagabe trial on Thank And Martin, you, Karsten.

Martin Lange

X-milligram as looking efficacy see to a the we and taking have [indiscernible]. don't step X had I milligram of back Maybe totality because Yeah. response a and necessarily some Semaglutide enzyme, semaglutide We at safety.

than in offering But safe a want is and a with semaglutide and to to sense attractive bringing a being being target explore component. XX% more That offering, obviously, think, component, semagabe. superior superior GLP-X the but also in way. in itself, said, we I of GIP of very the superior the tolerable

and strength II combinations doses We our into early are different detail. Phase too go different in and to exploring trial

Lars Jorgensen

we clearly We a Martin. believe you, have Thank Thank you, strong there. position Simon.

questions, set Next please? of

Operator

from the Please line Novod ahead. comes of question Nordea. from Michael Next go

Michael Novod

two questions. Yeah. got I Hi.

out we bit So the quarter. [ph]. first talk the course, of the dynamics can obesity about all, for between have split you a don't Wegovy Because, maybe Saxenda of and

sort to the Just trying understand still what of you was had obviously, had growth, street below it strong but expected.

listing on in impacts Ozempic the So understanding of international then on volatility operations. the Saxenda, and regarding launch secondly, NRDL. of in - also potential launch the the continued also And China or

in And lift on color in expect So maybe of of you China? strategy when your China? bit could you give Ozempic more a sort off for a true sort

Lars Jorgensen

up think obesity up you, in performance one deviations. XXXX. pleased with we strong Michael. The Clearly, should can in above don't quarterly fact in operations. hung get that international based everybody see a what And a had and a really we Thank the Wegovy XX% on Good. We're grow I Saxenda, and we what be Wegovy. Saxenda, potential clear people's and launch Wegovy we'll then for - of although opens prioritizing for that very U.S., is of mind course, exciting in is waiting

much China? I of Camilla Ozempic say in So can performance in we there. don't then think about And our on more launch

Camilla Sylvest

is to GLP-X. there that Yeah. and underexploited And to also patients simply once margin Launch further X NDRL to to say, the drive diabetes means was course, now a of have exposed [indiscernible] type on We GLP-X opportunity there now China weekly very, And in referring growth. more has big that so market Ozempic with of are exciting. very to. basically

So and focus for very a big that's ours. us, of exciting

Lars Jorgensen

Camilla. you, Thank Ozempic All so really have been far. embracing markets

So Thank markets. have like other China, Michael. high for any expectation you, we

questions, please? of set Next

Operator

comes question Berenberg. go from Next ahead. line Kerry the Please Holford of from

Kerry Holford

please. questions Two you. Thank

release. press on mentioned today in generic Firstly, the your challenges you

across And if can companies So on you the We you in those with X here? understand be FDA, and of substance Karsten, the with total you concerned potential can obese X X how what highlight that the I that question, secondly, wonder states? also, you Wegovy steps And filings comment next the And patents. on show the read about M&A. patent, given would patent you for drug come that. we the a

You more products mentioned it [Indiscernible] here buyback on you. and or do conclude, therefore, this Thank in please? platform fair the to you acquisitions satisfy - for technology or are you context to have next more of Dicerna? share appetite flexibility. program Is post- focus What that

Lars Jorgensen

And if of Kerry. Ozempic, after the out a start you, exactly Thank this I on is basically challenge textbook.

So there's that. window defined a a certain and after route where launch for doing there patents attack is you can

be of So waiting who the see to would we first. kind were

I annual the think have FDA visibility the mentioned of we to of ones in has report. X, So the understand the I which disclosed. been we number notified on up remaining don't have

use So that confident in we Karsten, patents the appetite? all semaglutide, M&A standard on process. for this is on and very are goes indications. our that molecule of across And

Karsten Knudsen

Yeah.

assets into for from always external attractive I whether our R&D pipeline, So it's internal it's say appetite whether would have sources. or we

So that's of course, it strategy fits our the and assuming premise, our focus.

can have see sheet. We you balance our the capacity,

rate you leverage zero, EBITDA. a of have we So debt if to take net

couple have we back more buyback there. out And buyback down our years What that than assets scaling the would plenty given in program. our of market on funding share has the potential of that program. rolling so pursue you over financing commentary vis-à-vis we are So the the have our seen capacity of cost to be last share of attractive the of been out level

our approach So that's allocation shareholders. to continue our allocation to provide capital attractive to capital

of we course, platforms. the say I'd to looking targets - we're As relevant at, continue to technology for look

parameters, areas disease assets And which where attractiveness, compete. cetera. then we're commercial et safety we the early say, And at So and across innovation, space categories the again. have set of in it's, financial fit of course, would a therapeutic I early high could to mid-stage will we assets looking compete the that very the supplement attractiveness, in criteria whether

business succeed a And then get door at in along. tariffs of to development time, like. And and So all time have classic the we from the funnel. lot which we we assets looking we're some

Lars Jorgensen

you, Karsten. Thank you, Thank Kerry.

Next set please? questions, of

Operator

line from Purcell go the The Morgan next of from Stanley. ahead. question Please Mark comes

Mark Purcell

Thanks questions. Yeah. much. Two very

the context we And on How a where First percentage in flattish earlier XXXX. second operating spend then sales a your [ph] margins back is to peer to spend on expect platforms And PED R&D should as of low-XXs. Cagrisema. in this existing out high with Is on going conditional couple of R&D the go? that adding group? to the group R&D high-teens, questions question

like in competitors about of site One of how that. injection your antibodies, calcitonin activation sort signals reactions around talked things the and December antidrug

on we when should as respect those we more to we assume safety should So the get opposed aspects? positive And you. XX-week example? data, see should Cagrisema? that sema with for more you're GIP When now to Thank

Lars Jorgensen

Thank you, Mark.

operating First, the about margin to impact and what profit ratio? a expect R&D and question on PD

Karsten Knudsen

Yeah.

Day our questions, So stands unchanged thanks towards Capital for margin since last Yes, Mark. commentary that set operating Markets XXXX. broadly of our

scenario a opportunity our that at Of margin in the kind course, an on operating then specific one. if not end with time. of impact can come one-off margin. more point type there's to would And cater stick into we that up a a every now, be clearly that future. sizable we'll the opportunity broadly It's is opportunity by But our we for unchanged right impact situation stopped such should possible a of where deal has margins impossible PD for to in up we the

you ratio, overtime. should increase to R&D expect to that As

You'll 'XX. already - you in see see decent increase a

come importantly the increase looking at that at how actually given investments the on both the more margin, look You'll side our into our we I further pace side, than is impact. is. the But research XXXX increase see to fact Dicerna much growing R&D, think able even the are and at should the then you development and top-line it

reality funding So kind our top-line R&D diversifying and main our pipeline and the growth. organization currently is of mechanism in to expanding

Lars Jorgensen

what play. are we A on moving assets, Thank it's say shrink. ahead powerful a can position of And not a from model. But have about? defensive Cagrisema. we Clearly, Martin, Karsten. X you, you

Mark Purcell

So in that clinical one on II. safety too, XX on think take XX Cagrisema, Cagrisema, combination we fair two of to you that I including exceeding it's that in exposure in that of second, intend on a to doses And state semaglutide based exposure very, looked we it very therapy, to intend in in is those frame, was take trials very at that also Cagrisema. those to or And weeks to exceeding time similar into on we both confident - again remind profile weeks. place. which monotherapy. trials monotherapy, safety we have we XX In analog into I'll the we with up in being weeks in in Phase are proved doses of [Indiscernible] our combination amylin be to that semaglutide when combined, monotherapy, safe

as very very, than that obviously therefore, perspective, you've seen competitive. seen in is very, robust. And efficacy we've super cage And It's is our far what is from all safety So molecule high. profile profile before, an that more confidence robust. very so a is our also the

Lars Jorgensen

Thank time of have encouraging. questions. you. for And Martin, Good the to Mark And hear, final we thank very for questions. you, set

Operator

from comes question of Please final Martin Bank. The ahead. Danske go the line from Parkhoi

Martin Parkhoi

will Excellent. point couple and I Bank, towards them all Parkhoi a questions. think North America. Martin Doug I Danske Absolutely. And from of

the thing of and one stance operations. when as XXXX, that for towards I Markets look all, for in while me U.S. when willingness First did a that outlook on you guide to Day a remember, back international the Capital quite Doug, America muted I on highlight I XX% was at North

are - rate panning kind at seen see what couple after we year. always America also actually that seeing you high maybe U.S. you the Now for market XX% tirzepatide? very launch North out the base. in in really larger will a - push was from outlook of but a for What the the outlook upwards, and launch maybe We already after a muted years? not for next think we context, that dynamics of new the much the are GLP-X you will with of this have address market And can will

will So further keep it market much that. expansion? more this market be than to about share I'll a

thanks. Okay,

Lars Jorgensen

growth in step-up perspectives compared Doug, per guide we U.S. growth future perhaps on don't Martin. the we market. what you, Thank - on in 'XX? to But in a at looked while the clearly,

Doug Langa

from take about consistent not of to how would business with year. continue again, I the and or Yeah, our pleased aim diabetes. I but business disappoint on reinvest hit growth what progressing to products short talked NBRx, progressing across that volume Martin, and them transformation the back there. is obesity we continued see the are goal do at legacy very transform we will term products on. were you'll 'XX. want But our around in What to goal by to And we the ability I you by Capital year. the or our don't again, in about very mean, good guide at encouraged XX%, we we're and considering is the And business. XX% Day. There this that portfolio. into growth can the come of we from ability this, And We we're U.S. how was then our Markets ambition was very And we're with which today. share. to XXXX to going to semaglutide, to We're the what form this things the that expect some of both about of feel talked was say we're And believe newer U.S. or novel the transform end and products about

There's capital are for back into still getting on this of markets like roughly to when XX% of introduced mentioned still we at which space, plenty As XX% prescriptions, tirzepatide room [ph], far the in is get of XXXX, as value. GLP-X. products maybe patients

believe be we can have do of going the product, competitive they'll being I'm also we Ozempic, But bring and - further category. competitive the to potential we with they're muscle. we the have expansion muscle of a momentum products believe competitive And and a It offered. portfolio of additional approach. introduction that marketing bring be So will product further great sure a

where So pretty are. about we feel good we

Lars Jorgensen

be Bye-bye. the Good. today. look Thank a Doug. Have We easiest against. and not Ozempic a it this, Thank go day. you, Martin. will delivers future. we'll is Thank close to forward compete for you molecule earnings our you to the can you, product call And you. again with sometime great to Clearly, also in meet

Operator

all attending. you our call. for Thank This conference concludes

now may your You disconnect lines.

Novo Nordisk A/S (NVO) 2 Feb 222021 Q4 Earnings call transcript