NVS,NVSEF - Earnings call transcript Q2 2021

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Operator

Good morning and good afternoon, and welcome to the Novartis' Q2 2021 Results Release Conference Call and Live Webcast. Please note that during the presentation all participants will be in a listen-only mode, and the conference is being recorded. [Operator Instructions] A recording of the conference call including the Q&A session will be available on our Web site shortly after the call ends. [Operator Instructions] With that, I would like to hand over to Mr. Samir Shah, Global Head of Investor Relations. sir. ahead, go Please

Samir Shah

statements known or from listen much, you different statements. morning contains by again to call, time factors. in very results, information risks, results. everybody; performance other presented expressed for good and big this to the spending thank all and any uncertainties our or and you quarterly such materially forward-looking and The today good afternoon, participating to Thank of may to cause be unknown and achievements implied These the that involve actual results future you

U.S. some For respectively and a that quarterly description refer these Exchange of most on XX-F results of were Form filed the Commission. and recent Securities its to the company's with X-K please and Form factors, to furnished

you I across And I'll thank Narasimhan. again. that, hand with Vas to So,

Vas Narasimhan

Karen you, experience conference today's like of executive for broad with team, Samir, and have years the pharmaceuticals. over Legal biopharmaceutical us call. range industry from a Today introduce our everyone and we'd members Thank devices me I Officer. and Karen medical our Hale, XX joining also of joins in new Chief thanks with to

So, Karen. welcome

on five, on focus we the period. to if move delivered performance by we've and rolled consistent out wanted company, as over the recent journey slide can start to reflecting a So, company, we the been I as our strategy,

first-half performance our at subsequent strong. XX.X% execution our XX% back to the XXXX, four we've that our been from Going at grown operational sales Innovative you margin of financial income of operating our demonstrating our at have X% grown over of the a to And the XXXX, for core years, XX.X% first-half first-halves in the look CAGR, has -- Medicines the CAGR. when

Management to that currently remain XXXX can of we X% of in sales XXXX confident actuals $XX that billion we year, in we as at outlined and ahead, growth a a Meet confident our you a is CAGR margin, XX.X%, when our off IM we outlook, or last achieve. more, look the that where Now remain highlighted goal consensus we

strong a track for outlook growth Novartis. story record, performance So, a strong remains and the

slide it strong strong you at across our Now, for all was our look going well drive key for QX, as we elements shareholders. believe in of performance when six, the patients to long-term value as will that

growth income core had sales and We good strong, will that a with good strong was through in growth Our operating Harry bit more productivity, expansion. and go margin detail.

agenda, And the which and, critical in growth continued a some importantly, driving with leader of in journey on to XXXX areas these We be each continued will to And turn. I'll be innovation talk ESG, about milestones. to beyond. our we important also our

growth growth the our look brand. will to drivers. about good key when oncology next at performance the is then also as period, as Moving performance slide, talk you of demonstrated, a which Entresto, and more the bit start. over off I to we Susanne well our think, cover the will And and Marie-France a Zolgensma, key strong and Cosentyx, Kesimpta, strong launches drivers strong across various

a a taken the for quarter to account enable IM products key now over growth from to our drive believe and which sales. our we our demonstrates transition us I an decade. portfolio we next in portfolios wave of growing nicely will of older think of And are medicines which drivers Now next our two, together, growth XX% launches at these of -- rate XX%

up. biopharma in in X%, quarter the income sales two. was core eight, We X% and up moving also business to Now, word were slide operating saw at also wanted to saw sales the quarter, also say Sandoz. I a on We stabilize

year the look their current continue Sandoz, to hopefully situation. on assuming you when continue we of more COVID. systems But trend, stable to for the rest return also, do to story healthcare we Now at expect disruptions a the related expect back for a

haven't we unfolds. seasons And decreased cold back will in cough anti-infectives and this We hopeful can use, sector. all to but more how a stable and see again, we generic weak that a the situation, had overall, historically get we're

a that the Sandoz. right key well of areas also we've therapeutic GSK's the focus the our to and as in such as size as strengthened manufacturing said, pipeline, medicine. believe Now And our oncology in of biosimilars, immunology. anti-infectives made we brought And the we injectables, oncology invest the outlook doubled continue respiratory generics in are longer-term confident portfolio investments We've biosimilars antibiotics and our complex -- We assets, generics, with make new we in we to including portfolio. investments capabilities. in setup, of including oncology, in core acquisition recent in continue

high we time, operating over and XX So, to a outlook margin. remain of delivering sales income committed mid Sandoz mid core single-digit to

subsequent which psoriasis, that and the and been alone, growth want as already turning note innovation, well, broaden in do continued well building setting medicines. these progress essential on to but Entresto can asciminib, for our another on to into I'll more think strong potential us approvals for on be performance. mention next on I has We in innovation the as had I third earlier the enable bit in the also of blockbuster slide will I'll in efforts did other indications both in which in milestones a to we U.S. its we of the these lines, moving in about. And driver some slides, say more the to to Entresto U.S. moving which Kymriah And in third say line medicine to So, China, pediatric as the advances Cosentyx QX not had this front. important line our filed of ABLXXX has Alpelisib our believe hypertension, setting.

of already on And also the a to management, third approval open-label China second-half. deeper we is the bit already a hypertension. indication. this and indications essential Cosentyx continue Cosentyx, developing, range Cosentyx we've second-half, There on unique track on of has. the of Kisqali, So, believe have favorable in dive track that remain in strong which Hidradenitis building for to use Suppurativa we've Kisqali have we little the readouts on But noted, the with lifecycle Starting We're Kisqali's trajectory. two OS its strong in in taking then enable portfolio. the profile been would really a other as be supports readout moving we OS the mentioned readout, for to I for for our data slide our XX, MONALEESA-X

for We'll XXXX. about more on in We track adjuvant the Leqvio also in readout, are speak moment. a

wanted to to as data through studies we'll Pharmaceuticals, turning well but on detail, second-half. Iptacopan's Now are more Ligelizumab's track bit CSU the Phase a highlight go for X in in that readouts I

initiated progressing the as allergy well studies a urticaria Xb have and food now second-half the are Phase regulators start disease. with studies. we in for Huntington's study inducible Branaplam We continued as chronic to progress a with of agreement have And an in

are Moving also to oncology, our Canakinumab on track. readouts

moving that. and TNOXXX, the in I'll planned a Phase For more settings, wanted And inhibitor, with Lu-PSMA, about I earlier our both with well agent, SHPX X clinic that our the we've combinations in advanced we with the now currently highlight into started we're as with exploring. the combination say also to life as SHPX JDQ, submissions combination agents, also SHPX studies bit other already second-half, we've for have KRAS own now in our are that KRAS other but

of bottom on that investigator Lastly, our the has choice box wild Asciminib entered setting, where against card note I now here, is wanted TKI. Asciminib the first-line to in going

be Our Asciminib. hope them able It's see still of indication is each potential with these wild ultimately in a medicine deliver you worth the the that value to the we're we're these again be if this cards programs while able multi patients, clinical box, to blockbuster multi-billion a on once the noting dollar care of early, assets. that for able result has one deliver of we if would to to are potential transform across CML

saw our saying on action Now moving is bit you XXXX. January more PDUFA date now likely that a slide X, to Inclisiran, XX,

filed as for where secondary manufacturing so from the have as biologics, to other file the which do location is such well currently well-known manufacturing site regulators. agreed as We it's our the Cosentyx site, products Schaftenau we

I not raised We has believe the concerns the any to any -- of we've we've addressed FDA also have it's efficacy concerns FDA notable that or the that related had. the Inclisiran has And in raised. interactions of safety

will up earlier So, United very timeline. the of States. continue hopefully in important to move to resubmission, a this to We, there's we substantial where medicine company this the see FDA course, for market this opportunities time in work to with the if period. to can Class a potential us will is a place X But get six-month a bring very this now with

plenary Now had also PSMA and the moving movement slide, ASCO second-half. working earlier-line about of the Lu-PSMA, hard turning studies move and setting. in will the to result earlier-line to session track for XX% the risk next submissions on the a improvement the XX% death, in The likely in reduced a medicine really of Regulatory rPFS. and are you into remarkable expand into we're more with underway. that to the addition We're medicine moment. studies to the administer a relevant medicine, PSMA already And evaluating very Susanne X to are the capabilities speak whether saw

indications to at show as across at point. in a saw its a And in With next nephropathy, reduction the XX% range the this continues that note three-month Moving ERA-EDTA, IgAN you the important three was to months. we time it's broad of to a slide, quarter. utility primary endpoint presented iptacopan proteinuria

that we studies proteinuria, see this. expect over improve typically continue to in like We time, to as

forward will now was six-month to to regulatory in worldwide standpoint. stabilization APPLAUSE-IgAN, the there as the as this clinical indication. renal utility beyond ongoing and support of importantly, the IgA function, important is nephropathy very study, well endpoint. filings So, look which we at The a Also be from looking

novel designation well continue months. at trend renal also we we Phase our medicine here indication that PRIME support also XX% data new setting CXG now to ability already we for iptacopan, therapy, as in this to medicine of and function at the And to important B this this can unique this an EU is and And with at when to profile. with already an benefits tolerated. to proteinuria look as you both Iptacopan -- oral add-on be study gives would progress on reduction hemolysis, data ultimately impact hope presented in to with safety great well a for moving noting PNH, with as this also data monotherapy worldwide. stabilization next intravascular agent, is a the have We frontline its a we clinically Factor indicated us presented it's achieved. continue enrolling extravascular as at which filings X EHA the hopefully with the complement had inhibit months, agent expect usage three in slide, add-on that Again, Worth at to a we Eculizumab. We frontline subsequent a

we again completing filings the So, with superiority to look APPLY-PNH the studies worldwide. to endpoints support and then forward

as recent this children of As on have a didn't attract showing out on of in our met as SPRXNT gene well that slide, moving data. the independently Investor broad with And piece a of that range in primary we you've has was one indications treated SMA. sitting impact the might on expected hematological what setting. endpoint to one the that the came data can attention data Zolgensma therapy This pre-symptomatic substantial medicine, when the also believe have and remarkable In of advancing. medicine quarter likely XXX% next Day of have this patients range as a saw, immunological, the study, We renal diseases. as this a potential now as much

for screening for and a with walking are as and respect gains a met data these capabilities therapy in time, so over pre-symptomatic improve technical as children gene So with decade saw us around having continues in sector It therapies the the therapies building us world, interests therapy patients, symptomatic standing, through XXX% newborn are reinforces of capabilities patients Zolgensma of long-term learned as and be the and hope with continue to gene also secondary remarkable in identified to come. we leader a will gene the Zolgensma. over give Zolgensma that A for matures, endpoint. these allow who will SMA. much foundational to the outstanding Also, patients to treated with our we which This confidence to time. manufacturing

And is as to the progressing we Sabatolimab update XX% MDS next AML. in in given last first as stimulus X this ORR AML that Now, these setting. MDS that XX% which to IOA note studies, also slide, and within a have say I in moving the us of the of It with on move pipeline, a wanted studies program, on Phase STIMULUS action, confidence and it's reminder, the and pivotal an in Sabatolimab hematological And which syndrome. gave forward tackle agent both unique mechanism to are indications. myelodysplastic or the programs, show the

We the It's with OS the studies in as recommended the MDS have execution a us DMC offers of the readout, of worth to CR continued options. also the of readout at the combination, in course, Venetoclax. parallel did filing stimulus also time. Now, and these the a program, trials that And the PFS readout. range then have study blinded array a we of triplet including will third well come noting over looked -- that we study

adequately that med believe for So treated effectively needed range be patients we program to have options such as the would we a with can be of cover potential MBG. a that medicine

excited we've leader we been addition scientifically, a think area and treatment, many to for the So, program. AML in remain that an an MDS and be first-in-class very it years. as mechanistically important can about asset, We a

updated So this to program. on keeping we'll look you forward

moving strong ESG, to progress we Now had ESG. on

treatment been milestones notable pioneering proud X in think We able malaria; reached achievement. of X I our Coartem, with that courses to a some in delivered to leader space. billion be very a antimalarial agent effort our we've billion of patients It's XXXX. treat treat since to this

empower to other milestones and inequities also see can universities recently healthcare colleges commitment we with really in broadly over United in and that had XX-year States. the inequities quarter. American the African working of students address a black X,XXX historically announced medical We important the And the to you course education in

ultimately front this ESG So and our in to into for continuing embedding to performance. a leader on we'll long-term, drive progress long-term this business forward look our being the

to So, with that, I'll Marie-France. over hand it

Marie-France

XX% all Vas. you, additional revenues. good update dollars on slide morning, delivered you move to Good versus year we our prior growth to to performance. billion an afternoon QX pharma Thank and and we please in If XX,

also in As continue we portfolio make you also shift. our can to progress see,

excellent to with focus XX% Thanks drivers contribute are And growth and our momentum launches XX% Our our than showing on strong to top-line. growth. more these of now execution.

and up growth. manage we to You U.S. to in invest the portfolio. our can market Cosentyx launches, growth XX% If actively mature and quarter-over-quarter. and XX, expect as also volume behind shift move slide drivers now this QX growth continue sales back the we XX% with were delivered is in line

force in above Our growth we the momentum, really listing we capture in in to versus regaining we intend levels. And as sales market China, volume. field is following strong also had And NRDL Ex-U.S. the activity pre-COVID we March. QX more quadrupled see Europe.

treated can So with year the and to back our ESC of our further on as the our have the strategic been to to Europe, expansion our label. ACC full-year compared on patients U.S. also with proudly China Cosentyx. growth with on trust choice. to will that account was track can we're invest expand tripled capitalizing XX% approvals readout say the move double-digit and In expansion. strong year. and with the and that with sales on that and from growth in ongoing to first consensus next you geographic on we deliver know more see quarter of Suppurativa continued the based If We we're guidelines continue end position the we can saw now broad really the Entresto growth. the the investment. another to XX first-line is XXX,XXX access, our many benefit, indications And reinforcing Hidradenitis slide, short-term the that recommendations, recommend expanded now we towards additional previous NBRx very In ambition

In of trust is market. in fact, second China now biggest

hospital become level. is execution protocol guidelines, So educating the activating guidelines at and on prescribers focused this team strongly and ensuring on patients

summer strong XX, we is markets. slide of to open benefit stay remaining we You can as not trajectory slowdown, reimbursement expect I Zolgensma will the address up in move full-year, the XX% the patients If its as to growth Entresto. new do continuing from who see usual however we yet

got screening. As to newborn you to to And continue patients. pre-symptomatic for work data compelling heard that's Vas us say really earlier, and we've important implement

the As are you of expect U.K. to track blockbuster we reimburse the birth. the pattern, expect transformational we status additional on outcomes know the quarterly for the this treat more weeks U.S., year. to to markets in though some treatment the earlier even babies. and to are we drive see being continue few allowing we're this And Italy In volatility second-half. within the the can these a and screened of exceed newborns and in Ex-U.S. XX% growth is

start with to Our preclinical from next broad Phase time, are the we've the more prescribers in We've FDA And formulation Zolgensma. new studies well. doubled X QX. therapy. XXX Kesimpta as than number focus who on ready versus the ITU for our added If of is adoption to soon benefit we Over the move us Kesimpta the of progressing lines we're slide, of actually IT and patients number double as could the our could light. on patients early gives green

of the of currently leading see we Kesimpta second first got or And naive share the want MS space. Kesimpta The also that usage and NBRx in where the is highest this market dynamic class a switch. the BSO We to the is half be. recovery exactly is has

further. as well as the positions this So, up opens market

QX. of We're Kesimpta. increase what of of the needed really the the to we're what maintaining we voice know awareness we share doing year, our need for leading strong to do As and double demand to we move to is a second-half

important clinical PIRA believe and We that provide data differentiation. also our our IgG

We're fully need do. a focused on what fully also focused positive to we So customer experience. on delivering we're

There days. and action I In know we a on to cause is unfortunately initiation. at not we're are onto to but bring the leading Leqvio know the ASCVD approach is affordability for preparing XX% are due of launch. we and mortality fast got on And on we're within January, access, If our fact, that support receiving a challenges. we've and are patients easy move are dose and first new for death move XX, their that treatments, services And why five how taking Leqvio. too, different adherence the enabling of all We to U.S., patient slide is this date goal patients In market. effective and rise.

Our enable access actually launch of to two thirds strategy at Leqvio patients with $X could access co-pay.

track with we're working we're infrastructure broad than healthcare to partnering UK, systems on existing our CV also We in up to using better event on of this In three will over want a administration. to we're if and necessary set evidence this NHS years second take for and time risk absolutely outcomes the patients. that launch we approach to for the is identify level the next patients further patients bring Leqvio to ASCVD XXX,XXX more adoption. QX. and but We're drive with understand buy-and-bill ambition of So at generation,

our innovative an for on quarter, medicines. summary, also prepare our maximize of growth drivers, deliver strategy excellent to focused launches, in So our wave next the fully and we're

around approaches customer As want our much products innovative the shifts, centric pursue our to also we systems partnership we're our with further to accelerate healthcare launch more world. transforming be in business. also portfolio and We

fantastic a recognize out of to for around teams work their and we we take momentum QX, had good will in these coming which Susanne. continue across to I delivering want Over the work the So second-half. globe, results. to the hard moment for the you, expect

Susanne Schaffert

give update you, I'm to Marie-France. an XX, And oncology slide moving very on pleased the Thank business. to

business the quarter, performance growth oncology delivering with the showed in So very reaching second X% of sales solid billion. $X.X

driven Exjade/Jadenu and more than and now reason launches Glivec, the of continued year of Kymriah. overall our by initiated COVID-XX. drivers products Promacta/Revolade to on to and Jakavi, caseload, as XX% is momentum U.S. by areas depending Oncologists these And pre-COVID contribute recent in with affected showing growth good still are allowing generic market Our Afinitor, from are half versus to continued a launches that cancer growth Kisqali, the oncology below and most offset together QX, the like oncology us sales XX% and losses erosion portfolio, therapies prior hospital are reporting be Lutathera. In to Kymriah breast XX% affected level geography and

competitive. this grew U.S., by ex-U.S. and driven Kymriah, strong XX%, we the globally at geographic growth was very In Looking expansion. and it remain

demand in increase. in and ex-U.S. has referrals growing overall in positive slowed also down. double-digit, says the However, U.S. and class emerging we XX% as saw the from growth is QX, to we're it signals was the Lutathera started COVID

patterns to patient of improve growth segments. visits year, acceleration overall, remain increase and will of treatment hospitals to that second-half in So, will we confident further in leading these the the

to globally, Moving to bit U.S. our to contributing share performance remains wanted the overall I a is U.S. and in market our slide sales. our of on XX, oncology biggest XX% over

caseload brands sales. contribute pandemic now level. pre-COVID of oncologist to and XX% from launches XX% growth of recovering slowly The reaching market Our with U.S. the is

previous most testing the new QX remain types together for accelerating partial quarter. XX% seen QX, growth rates in launches delaying drivers In and previous tumor and whilst year, our we growing and have of also recovery prescriptions. However, recent versus diagnosis suppressed common

Promacta So the sales in this market of we Kisqali, expect the in year. this by of Overall, Taf/Mek. acceleration and the mainly second-half was driven the continued U.S. of recovery

restrictions X/X The quarter by slide premenopausal increased in where accounts mainly continue France, demand see we previous new access was with Kisqali Kisqali seen in is in getting million. market delivered performance uptake setting to and of and continued Europe. in delivering We by Kisqali Spain. growing also in to patients XX% have driven increased and start. XX, field Moving momentum were force U.S., leader presented sales strong updated MONALEESA-X with benefit our OS ex-U.S. in share sales patients At post-menopausal And OS of engagement median a X.X that we the years. ASCO, showed demonstrated CDK digital inhibitor versus Kisqali in trial data with over this first-line dynamic and in X trend. a based concentration only be may unique Kisqali high leverage results attributed CDK longest data We other with it's OS with the lifted that Italy, and X X/X And XX% gains data, preferential on reach consistent CDK the CDK inhibition $XXX OS particularly we quarter, on to from inhibit also targeting. the traction, profile these Kisqali versus those to of the driven patient believe the and a inhibitors responsive excellent in target. second through

are medical In population. remind with around NATALEE to population addition, we that in going Kisqali adjuvant and and into breast intermediate is track adjuvant of completed, population, unmet we in XXXX. just there's study the exploring our report to enrollment that need. very clear of readout study, are setting the early both the and And represents pleased XX% I'm the cancer high-risk you a on NATALEE this for

that XXXX. therapy the about prostate data we you granted a breakthrough trial XX, to second-half very Earlier is unmet in for track excited unfortunately And Moving are develop prostate cancer FDA potentially of men Vas, heard castration-resistant majority June, the metastasis the you filing of than the diagnosed is globally advanced needs patients time and the by the lutetium-PSMA and express the most cancer cancer remind to FDA got by second valid of cases, diagnosis. in on from from more VISION late-stage just with that prostate of slide we to who receptors. cancer, positions address PSMA of XX% as to

just relevance meet the treatment in awareness have raising to doubled reassure are preparation working with on top launch that physicians pleased PSMA. for also demand to we clinical fully on and are current to PSMA focus the centers of the target And a XXX month. launch. awareness last growth the on among see the has We capacity over in adequate you the Very

what through When driving focus with processes keep up are scannings. drive Lutathera. set need XX% more mind launch PSMA cancer to Ebola's PET to to effect the treated. patients where model from uptake need a that lutetium-PSMA the launch, and selected on referrals And and patients saw community factors will on versus licenses gradual our these you in be So at likely you prostate be of hospitals are centers

Moving preparation CML first to has like launch about Phase the next again. the at the major STAMP compared potential weeks Asciminib, to inhibitor response Bosutinib. would Asciminib treatments XX doubled slide, nearly In that for standards X molecular to slide a the to ASCEMBL I talk study, XX, the transform

FDA the EMA completed in two real-time filings is designations for FDA for have and oncology and reviewing June We and designations review. Fast earlier Track and breakthrough the and has file granted therapy Asciminib

importance first-line setting. it focus has on we Asciminib treatment the assuming therefore, are for are in we of indication to resistance plan inhibition reached enrollment intolerant just around related I'm patients TKIs. XX may non-hematological to third-line from preparing excited a Despite CML treatment, are we initiating XX% may study for patients CML and in We available TKIs the already potential. XX% prevent is of second-half that start benefit over and or that in you investigators off currently there of XX% 'XX. patients launch, advancements in the Phase TKI first-line minimizing believe lines earlier our on to more the than overcome events of the still years, remind awareness typical selected blockbuster in Asciminib, Asciminib As last X who to raising to suffer But target are relapse STAMP AEs. for versus TKIs of of very also the of potential awareness to and CML and resistance already provide by the Aided Imatinib

and 'XX is very submission. and So, terms important moving to slide innovation in progress a XX, our we great on have year of readouts made agenda

data, Vision positive show lung PNH, cell Alpelisib lymphoma data. positive not the line readout in is In very OS KYMRIAH But for and to did second addition cancer like in mention unfortunately data Canakinumab multiple important in from we non-small data had it PROS, Iptacopan in we Lutathera. to in read follicular readouts, studies the year, KYMRIAH OS cancer non-Hodgkins 'XX. line MONALEESA-X. trial line in and the second in track expecting data RDX non-small first and Later on cell lung ongoing first out second-half have line read two lymphoma, also Kisqali to to with we're from out more of that

and submission, PSMA, GVHD in Europe for in completed Europe U.S. JAKAVI KYMRIAH of In follicular over second Asciminib Lutetium oncology. we the line cancer; non-small thank we're ahead for Tabrecta with times non-Hodgkin's on cell that, lymphoma I in of cancer Big to and and second Japan, Tislelizumab HX, submissions to terms and for have in lymphoma lung hand track for filing and for third Harry. you exciting Europe and line in and all teams, so, line esophageal and

Harry Kirsch

thank you, and good Yes, Good Susanne. everybody. afternoon, morning,

for So you now some my the second of to And the refer walk otherwise financials quarter to in as year. currencies of always, first-half unless and the constant the rates growth going through noted. I'm comments

was So, Slide COVID resulting a $XX our performance the in by had two highest free second XX% grew solid grew summary offset the billion, operation U.S. and of billion investments. quarter first-half. also see to sales growth driven by for higher drivers, and to core two, operating up growth billion. gross during the first-half the dollars you'll XX, key of mainly performance, to XX% driven $X.X $X.X We $X.XX the and Quarter X% and favorable sales cash the to flow Core income EPS in XX% our partly grew despite a quarter impact in strong by net period. margin,

the two, comparison in due the COVID base the appreciate XXXX on low the from destocking Of in year. prior course, to benefit we quarter

to income XXXX X% excluded, core operating sales growing up X% still two growth with underlying. in healthy quarter when return even However, we

EPS the Our with half X% billion. and was top on one $X.XX X% the line on $X cash flow X% Core bottom to and was free growth performance grew line. solid,

half one, growth these of the washed the for one underlying quarter so out, prior-year two, one, stocking values Of from destocking course quarter represent has half XXXX.

please. slide, Next

strong So, Even to into I for of top quarter line a on and growth by with our Innovative and in slide continued adjust Innovative performance still Innovative drivers launches growth X% double-digit the Vas if half Medicines oncology sales. our we XX, growth the thriving with launch growth XX% of X%. drivers presentation, including of portfolio our want last year's sales Medicines earlier XX%. as up and income strong and by dive are Innovative brands. division. base, growth rejuvenation, increasing operating saw for a Cosentyx, Zolgensma delivered performance Entresto, and strong core mentioned plus account now bottom Medicines And XX% our the driven Medicines and during plus margin quarter lower The line key over we was

our Of also two with X% from last bottom is business, segment, sales stabilize Sandoz retail particularly to growth anti-infective destocking. growing quarter did pandemic however the now up X% and benefit impacts business course still although prior-year Sandoz beginning in the line and

for Now turning on group XX, both full-year operating full-year core our slide to the confirm we and guidance guidance sales income.

for sales, sales. bottom low growth of continue and we line, expect ahead expect to to in XXXX For the mid-single digit digit we mid-single growth

also Medicines making Sandoz, not Innovative we're and any For changes.

prescribing to sales to expect mid-single Innovative core continue dynamics addition, to we decline key U.S. Gilenya, single-digit year. that generics second-half provide global to of to in income of grow XXXX this and normal in next operating we the mid-single systems slide, no would assumption no to core LAR And of some healthcare mid one detail in enter for full-year. income Sandostatin in to sales. to for in the and the that digit high continue the assume range, On We return expectations bringing digit continue the from digits, range a for of see us expect for year, we the second-half guidance digits, accelerate line the mid-single our grow mid-single climb to top to to The low to ahead X% in to growth on half low the and we we expect mid-teens. continuation Medicines division Sandoz, to low And sales to is operating the

be to that will as is acceleration this growth prescribing driven by return well as we further to continue normal Sandoz assumption stabilization. Our behaviors, as

We driven growth full-year. expect core digit single digit in reaching as will drivers operating income and be higher that income pipeline. fluid. high be half you productivity COVID situation expectation end for still growth ongoing Core partly our could two possible the ranges reach know, and mid-single offset But programs by sales operating the This in of the we growth provided. higher the by investments we will have our remains increased

rates. constantly exchange attention estimated currencies want currency changing, to using I your slide on bring Finally, to the the our as current XX, on results impact are

and rates on operating remainder positive if impact So of X% sales XXXX, mid-July positive be of X% points. would prevail core the for currencies income on X% the full-year to

two back it this one I'll and our And three, Vas. update estimated on to on sales quarter impact hand basis. X% a For positive monthly with that, we will income. And currency to be as positive core website operating points on a on always reminder,

Vas Narasimhan

Harry. Thank you,

range So, next look goes a XXXX, have still good we when you pipeline like moving the course the to the to at of over year. catalysts broad go, delivery of slide,

programs. forward we the second-half. note, look exciting and to So to we mid-stage think of innovations generate, we I'd to also I advance course our over you continues emerge will which be updated pipeline and to able continue our to hope new these the keeping assets pipeline as add

Now the XXXX Iptacopan, our and you've performance for also drive advance Lu-PSMA to you've the growth growth positive continued to seen seen slide and driven had our for the the across our We've I performance you thank key moving reconfirming driving the QX and company. presentation. medicines, our readouts over as long-term of commitment beginning, our we're long-term and And we've by future novel continued close, full-year to your consistent guidance, at just growth as to company. throughout commitment accretive strong others pipeline to the last the years outlook noted is in the recent drivers for the confidence again,

that, operator with the to questions. line the ask I'll so open And for

Operator

Thank you. [Operator Instructions]

Vas Narasimhan

two questioners it. I limit if you. could could Thank appreciate one we to questions, themselves say would If Operator, thing.

Operator

you. Thank

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

open. is line Your

Wimal Kapadia

commercial heart I'm thinking from timelines, impact But on they're I quite different. do how fraction just Novartis for different come you in data and to Bernstein. population. be I'm [Ph] following level how the markets an Kapadia interest the top a [You My it much failure, competitive are on preserved quite and and used very profile naïve interest? the down just I'm patient, a is ejection thanks of positive are have well-priced probably so lots interesting which of curious taking great, not Iptacopan, these] impact, my thinking now in data question reasonably indications efficacy potential demonstrated Oh, about Novartis from any out and questions. confidence drugs for curious robust Wimal across appreciate of second drugs Phase perspective, I'm a these of of about SGLTX just it'll recent of have know, in expect drug curious demonstrate your just interest and see recently will in quite dynamics is multiple but for size X. indications, that efficacy to

multiple by So, ultimately, price to how could could should be the across success Alpelisib points is acceptable likes the from and limit prioritize, competition indications, different quite given Thank of we see you. Novartis potential? going particularly indications the

Vas Narasimhan

Wimal. Thanks,

Marie-France. So, first on SGLTX,

Marie-France

So, thanks for the question.

you As the said, SGLTXs add-ons. rightly are

full were we'd very that's to that heart it's And previous expect focus to patients covering bottom we to a is if seen sure in is of used going to look of even care of five patients position. really the data XX% the U.S. are really past, at we've strong so, release, think got the Entresto broad on diabetes unique be the And and in different. actually and predominantly Entresto. standard breast to them out about with we're The only we're chronic the readout new who line six have continue the in switch label of we the failure, press making with quite trials because a in cardiologists, patients

I continue an And we Entresto. the between we compelling with if the momentum have then that what have have, to takes the think it SGLTX infrastructure, commercial team is support do. thing in add-on, we strong the the need excellent data, place, So, guideline right that the to patients

Vas Narasimhan

Marie-France, Iptacopan, think I as the and outlined. is to with to across respect thanks mechanism of see of leverage fully range overall and you we've unique strategy, then, profile the our can medicine And this indications

fact moment data-driven, at of taking we the to to oral, determined an data, but Now who course, disrupt be it are goal our the a sequencing is, one least, the and patients markets of broadly safe moment hand, IVs can the the on be basis. ongoing that have with will at taking existing at given that will on be size by

very standard so, And care. there's currently to think market into illnesses have completely a new a attractive of there. strong disease, renal haematological in then don't that segments And profile enter we very

across indications so, the us Wimal. pursuing. how of that's you're fully going numerous full to see And range to approach asset the for Thanks, maximize

question? Next

Wimal Kapadia

you. Thank

Operator

you. Thank

of comes of Bank from line question the Graham next America. go ahead. Your Please Parry,

line open. Your is

Graham Parry

questions. my Great, taking thanks for

first Kesimpta. So on one is

data Thank consensus in less if free down percentage consensus add-on to you because said can of in the event? might you the first-half recruitment see or get it's even that you. getting free trial, drug wondering that now sales the think complete, first-half double you Just to in take expect to and expect second-half you do you the number? on then that what a is how narrow you dispenses drug, NATALEE I you could you to demand XH you the secondly, second-half But drug XXXX you're beat And window just if and actually when that, as the and twice think around XXX. of be first-half

Vas Narasimhan

Thanks, Graham.

Marie-France? Okay,

Marie-France

lines focus that we understand early key that the broad early. important to efficacy in is I our really think because adoption so it's on therapy Yes, everyone say our And value I for strategy want ensure high really of B-cell therapy. of that

prescribers in we're leading we lag, my the a and is fast also happening share on have year, drugs. that As of to opening our in there's do twice paid new patients given and second-half as conversion though on easy brand about to on Kesimpta of quickly, free we have the XXX I free bit a focus, all And consistently voice know said the always starting many in got we going really familiarity around we still market, know of focus consensus our the really of even so we're comments, to are place. what continue and initiation. patients enabling going in QX, new about some and we've We fundamentals on on the have differentiation is to scaling

to expect external growth to with know QX be expectations. in we Medium what the strong comfortable demand deliver to We Kesimpta major we're we a a double full-year, the really driver company. for QX. So, and do need for term,

Vas Narasimhan

on then and John? Marie-France Thanks NATALEE timing,

John Tsai

our On the increased which from earlier as have advanced Graham. the NATALEE, includes Kisqali, recruitment is to and disclosed high X,XXX for the patients adjuvant intermediate had year, that both study X,XXX Yes, for thanks patients risk this who question, cancer. we've we last breast and

to it's expect at is out final to next that's powered. that read currently how Our be and of we end going year result the

As we said previously, interims. we're disclosing not

So we're year readout. year the our currently next powered final for of end the for

Vas Narasimhan

Thanks, John.

Graham. So, lot questions, the thanks for a

question, Next Operator?

Operator

you. Thank

Your Suisse. Walton from Jo ahead. go next Credit Please comes from question

open. Your line is

Jo Walton

first Thank about spend. you. question marketing My is

marketing can can bit very at spend, in a second you've spend level know or for to you've more might I sort China. third more the of and would of a on But a digital use the a and a of if in now give at quarter, second saw So long-term you quarter perhaps marketing marketing be you're with because be spend, the of opened the on whether up, your second of in of we quarter things feel learned of that enter your how confident last you little get capacity year, and as that think all how COVID ask constriction don't and you're idea side then clearly, what in you how sense whatever. the sales some be my reduction everybody's you question lower dramatic detail to of we level able or forward, going sustained marketing

you your of tripled of please? idea talked your little level bit investment, You've an us of of ambition China, can drugs, just sales, about where in and quadrupled sales; give you've level a

Vas Narasimhan

Yes, thanks, Jo.

hand trends, on it first Harry. marketing I'll So to Harry? spend

Harry Kirsch

Yes, hi, Joe.

is than locked last actually year spend spend, the China, marketing the quarter playing U.S. out, earlier in higher we were as as markets out basically you to on is maybe but quarter it's which where two quite the guided also down, major So than two all year, other pointed

X%, X% wouldn't saw that why the income operating of out. the margin in sales playing with that I we also see guided think And of that's first-half, and we we So improvement. core also

expected that three at investment of would within course, expect levels the is more quarter sales I improvement that our on needs. normal, programs some growth full-year last that as that quarter also, margin growth out our to then second-half that be But of year, would year level out had were productivity say and a manufacturing on low spend laid certain I nice and overall last displays two continued not the especially have where marketing we the it So in four healthy given in the very spend margin levels half leads will sales also improvement. guidance guidance,

expect most mid-term, a and I mix highest markets more in still will be major somewhat would in to one goods on digital, with the margin. mid-term face be that drivers the change our the XXs, to of to do Medicines continue that initiation. SG&A the Innovative a productivity to I expect Now manufacturing, SG&A cost in important, is the especially driver together our but certainly face especially through of increases, major But for of being work improve to margin in bit launch

Vas Narasimhan

term framework to bring [indiscernible]. our out us a step the us to regulatory to effort China a take in Jo, would back, adopted as to we really enable our there at changes an Thanks, the China few both a the to in programs necessary second, infrastructure, drive that medicines and ago, well we building X investment full that the then Harry. as oncology sales longer start, in And China, forces enable first years in portfolio And so Phase of began growth. China, on including in pharma development putting really strategy given

double the in high in our So, the a from stated today, business our forward China percentages size goal we're on fast overall on track we're business growing from China XXXX the baseline. teens to of

new XXXX if China not players XXXX, that's be of top to primarily amongst We in more one prevail, trends the driven by medicines. if multinationals, by expect three current

things have continued our in we driving So, Cosentyx. success ultimately timeframe the of NRDL growth, overcoming portfolio that that with the get that tendered, any newer strong as on saw medicines XX approvals the you potential

become and China profitable years accretive continue prudently and to see in the Novartis driven market from come. over we we'll largest we being the second So China growth invest to for in there, to expect look world, the to

the questions. So, thanks for

Operator? question, Next

Operator

you. Thank

from ahead. from line Your of next question Andrew comes Please Baum Citi. go a

Your open. line is

Andrew Baum

have you. couple of Thank I a questions, please.

FDA second that bible significant your at and year. on And it the NATALEE to that with data end the next of wanting on satisfy you'll PENELOPE-B of see duration have you the follow-up? sufficient to given further are how How disease without the the First outcome question Ibrance, rash approval business Aducanumab, We've Kisqali Many the fields, you comfortable trial, comments influencing has trial then a your newer as had if of Novartis recent development. neurodegenerative And a doing your mRNA thanks. in we've the of space? also obviously on then, surprising neurodegenerative treats that your is seen on comment of his interest interest could develop competitors platform? how Chairman's in

Vas Narasimhan

Yes, thanks, Andrew.

the want take to situation, John, On you that? Kisqali

John Tsai

our intermediate high-risk Sure. taken we've we've earlier, and patients I NATALEE look, said question, Thanks XXXX, as a for including in patients. as the increased both Andrew. number trial XXXX, of from And the

for One treatment. at we three patient is have duration, focus As things -- on. years these treatment overall we couple population, there's of a longer that at a look of looking this the a we duration

the first us the in give in patients, particularly We've at of confidence year. the approach. looked should that So also adherence

know, what look on staying at drug that milligram at metastatic treatment patients is we've least arms at important. and is hearing the early we you in both dose. disease the patients, as the As patients at And are seen, these XXX across these micrometric of

two the next components, comfortable at those with readout we specific of end feel So with the year.

Vas Narasimhan

John. Thanks

watching we pathway. course, the approval in changes use the And business are development, so to on approach accelerated of the of

for noted, assuming have Huntington's way Phase As entering disease, as clinical how XB, a within best there's submission that bring ongoing trials. the internally, many forward, the new positive already disease also if to we we've to then in efforts and we'll neurodegeneration regulatory decades. had program in neurodegenerative we've And potentially country consider certainly accelerate

gene well Alzheimer's targeting using continue disease, interference, have siRNAs programs Huntington's biologics, as therapies. diseases, both as and ASOs other well as know, as neurodegenerative you to we and RNA As

mRNA I So that will the continue. how applicability value as comments No in always are on On we're more neuroscience. again, In could bring as more attractive and space. think to mRNA space, in assets vaccine have see within based for to given efforts not our watched much space add, ED&L. COVID the course, specific continues broad neurodegenerative of looking we've have to broadly the to mRNA in curious

internal a We have -- our also any will we'll interference, the more technologies, continue. sense substantial evaluate approaches work any own obviously, Inclisiran ongoing ingoing continue sensible manufacturing those efforts internally, nucleotides and have that of RNA within there on at is manufacturer mRNA, Pelacarsen, siRNAs with but in nothing to so moment. were with of for And if broadly, in efforts imminent,

So thanks, questions. for Andrew, the

Next question, Operator?

Operator

you. Thank

Stanley. ahead. comes question line of the Please from next from Purcell Your go Mario Morgan

Your line is open.

Mario Purcell

you thank very much. Yes,

looking bit in U.S. before then initiatives currently. XXXX, future inspection? And then we the Could elaborate think share you wait about those all, around thinking in And initiatives, anticipated of of should we wondered terms new for inception, on which I FDA these secondly in How kicking the third-party? you. split about B outcomes markets a Kesimpta Thank us XXXX. and of data you give the your First the now by supply little new mentioned we on a those evidence launches outcomes the off of how latest if then of NBRx outside you end about the What Inclisiran of launch initiating and first two a ahead Inclisiran are to parts more you're sort the And part. should think thoughts disadvantages in formulation yourself increase those for those and site the advantages sub-cut the U.S. XX between therapy others, base data? behind are cell

Vas Narasimhan

Mark. Thanks,

outside the subcutaneous Kesimpta, Marie-France? U.S., on first So,

Marie-France

of Yes, at Kesimpta look launch important -- got And the XXX,XXX versus are alone, U.S. are for on low patients therapies these more living I And therapies. on Actually, if is us outside Europe we've if of patients the many with efficacy efficacy an many low patients just MS. I U.S. so,

through have So to infusion working But also now currently -- access accelerate don't is and a we we that also of reimbursement lot working what these centers. what patients access. you're to know

be tells that physicians used therapy comfort our of a patients So patient's can a will us the self-administered research in that home. appreciate and high efficacy

to own in working quickly So, with NBRx the to do patients reimbursement the possible their right we're what our is to know your country globe. as need system. each Kesimpta U.S. question, And now through NBRx we bring share we currently, On XX%. around as

Vas Narasimhan

predict Novartis inspect. and things, if the the Kesimpta, ex-U.S. I you effectiveness markets remote recently look our the system's case FDA in the not our given of U.K., indication. inspection on access formulation shaft demonstrates for on FDA shafts of site a can't And moment will the a or there attention value has one U.S. been on our using focus in manufacturing overall approved recently rapid Inclisiran, On production this side the use regularly is would high ability very that subcutaneous is on I at at notable the and just zone Its we facility, also out the to now of cost to inspected inspected line a our study is note where therapy a of by has mind. a in this get been are whether think in

build think FDA. the the Marie-France line determines. inspected used see have then of so, And terms to is maybe I data And and that the ultimately efforts to out initiatives, regularly by we'll a on the data FDA that's what on notable it's Inclisiran. in this But

Marie-France

of the that you that obviously, Entresto, know evidence some saw on to from need Yes, we generation. mean, I slide. we build And so learning

at You when it also or the primary Inclisiran Ezetimibe. of or use the complement know acute no trial, prevention studies. we're example, about looking looking use But on with syndrome, ways initiate efforts We're different of our data for for. outcome enclosed comes to accessing, to on around V coronary the also

around want of the product level we to ensure uptake. that's build tech so and generation So that evidence fast can the we that

Mario Purcell

Thank you.

Vas Narasimhan

important and just continue to parties. Yes, various to want we I work that that, add with

a generate demonstrate have scale large States, scale of we partnership organizations announce we Inclisiran on proof Association, past others, a highlighted that to updates in year point large which that's and over So in with at be also can will can the partnering very with healthcare the think our systems. the the also the generate will something be in Inclisiran the used but major that on volume we've important We're United hope second-half also American evidence, MHS such that I as demand we utilization for and to Heart medicine. hope

this we'll So happened. keep updated you as

question, Operator? Next

Operator

Thank you.

Papadakis Your Deutsche of next comes Bank. line the question from Please Emmanuel from ahead. go

is open. Your line

Emmanuel Papadakis

Deutsche filing Thanks PFS from theory, the Maybe readouts, the on the question. guidance the MDS-X has of in Sabatolimab, this deferral a in second-half effective on for year. long-term original for taking a CR Bank. I'm been question readout for the

recommendation continue of interpret years readout? couple So that's until to or Unless what can PFS a mistaken we I'm on efficacy data from the away. that decision monitoring

in you may I How national build? plus potential said you've are next indication? discussions data? you terms sounds And given newborn incremental then is level Europe. particularly blockbuster your light rights pre-symptomatic a it not question one year, since like around or just XX% be on Does much QX. slow progressing guidance guidance has in dollar it Zolgensma, of inflect that changed about going a that [indiscernible], impact as screening that if in of And quick to does billion on being So, helpful then, relatively around

waiting had the on be were you listed. that zone think and you you trial for to I said clinical hold agreement the

Thank actually those new Or the few happened ongoing? So discussions -- is anything are last you. is it months? in

Vas Narasimhan

thanks, Yes, Emmanuel.

John? readout, CR Sabatolimab the on first So,

John Tsai

TIM-X myelodysplastic Sabatolimab, therapy IO the for AML. our for Yes, know, you is as syndrome this first-in-class and compound, our

had we end primary point study, and in remission, progression-free the being originally as first told Monitoring and came we At complete earlier of study the planned. primary us the designed complete Data Committee, of the readout continue that endpoints two number this points, the to we reached the we the DMC, back the being as part year. end As point, survival. And remission point second always end

shared seen was of readouts. earlier that number you've slide by Vas of terms So the in the

we but at seen, only you've As actually MDS, look not also AML.

differentiated for for the but fact asset look do a potentially not So this, to of we risk results, is us this a that it on and has AML terms MDS, at high also durability profile safety of that the only we think as think based good about pending efficacy, in response.

results XXXX the in await and we So XXXX.

Vas Narasimhan

first-in-class medicine. that? significant you think results how say there's options on Marie-France, newborn incremental NBS dollar-plus I out. asset doing on billion change a different different Zolgensma, to other beliefs with doesn't therapy It our any do the we're or medicine Emmanuel, want late-stage therapy depending that that the a a as screening, the And than has given highlighted be multiple that filing we mechanism can play the word about On how existing and it's

Marie-France

that of information. I so will U.S. Yes, implementing know the market this of -- can in Belgium I some We've so From market, doing is are be I you parts other screening is screening. that give I gradually. that, countries the from say mean, by year, October, a beginning implemented we the Europe across mean, that see we'll gradual. the this. Poland Germany got really by would just it U.S., it's newborn outside is high,

are very important saw are the results early. know mixed amazing that We're the We really that Zolgensma So, it's and early. babies to SPRXNT it's to treated a how picture. data We start from committed it. when

it us. the course, is priority get then, So And older of medium-term, we to a to formulation. for our IT bring Zolgensma children is goal once

Vas Narasimhan

on no another Marie-France, the on [indiscernible] just And Yes. updates, thanks is that, word Emmanuel. there

resolution preparing we with the work studies have We the design provide for for of updates FDA, we course, company. can the you. as continue Thank And and indication to with that agreement resolving FDA's finalized the on continue topic or soon be a the to the multi-billion will, X indication concerns, dollar on as a belief have it. preclinical FDA the with execution do operationally the protocol any but Phase we through

Next question, Operator?

Operator

you. Thank

Your BNP. next question the ahead. Parkes Please from from Exane Richard of comes go line

open. is Your line

Richard Parkes

much just very thanks for my Hi, questions. questions, two taking

and just delta U.S. the sales a it guidance. results. least scrip quarters, looks few I some Promacta, and could like sales last up question am look at And legacy healthcare wondered double solutions channel confidence you. with out in of your and XQ the your first-half, and thoughts as and the whether been planning on Thank scrip the on at updated given wondered beat quite you of you whether secondly, could what per basis I you surprised continue those could Tafinlar, increases. variance mix oncology you per you the be that. to over significant other and might factors then, which if if sales just haven't trends will opening discuss are of maybe digits, growing you've set assets imply impacting seems any that. you that the trend in price both such your discuss just for XQ wondered in your on positively add that just adjusted that that margins I specifically And what impact on has for expectations if Firstly, that there systems Zolgensma

Vas Narasimhan

Richard. Thanks,

First margins Harry? and on sales outlook,

Harry Kirsch

hard Yes, you understand, briefly the bit repeat. could Richard, line was a to

Vas Narasimhan

surprised that guidance we think rest Delta on out Yes, how do we the there guidance how were Harry, see variant year? potentially the play the any QX, question QX impacting if us the of versus things and gave after the our I for would QX was,

Harry Kirsch

okay, Yes, thank you.

more we So, than Richard, what bit delivered we obviously, a right. thought,

in So work But addition And innovative colleagues always in our ahead bit two. in but internal of would I supply then very Sandoz expectation, in I with momentum is would brands. some of we levels. our saw U.S. say perfect line better, a most overall. better expectations good from reopening, faster overall say, on manufacturing productivity quarter to medicines, slightly also pretty our some much

Vas Narasimhan

when surges the dealing not that ensure We may healthcare they impact and that of they Yes, the that that Richard, or respect that with are how get while diseases have healthcare to substantial systems seen will monitor is variant, systems that What impact shutdown any may non-communicable expecting patients the patients we optimistic on with to with think care the the to situation. remain I thanks. we has. happen they -- continue delta COVID-XX. given need

Now on performance, Susanne. Promacta, U.S. Taf/Mek,

Susanne Schaffert

note, main U.S., competitive. this it's update are And earlier indications, Yes, performance with more we as little even you volume driven. and on still on And very really is geographies there rightly had you that thanks and Richard, remind growth, Promacta we our lot. Promacta a and the it's label a you maybe actually all it very, pleased XX% give growth, bit really more a SAA. year was and granularity makes To ITP the just across XX%

mention growth the is and driving over it's Ex-U.S., competitors therefore got benefit it's It's are XX% share saw rose very markets the very that non-immunosuppressive like EU. convenience course of also And strong NDRL performance also in end major gains oral increasing to performance. just where previous the underlying China, We we And NBRx. mention strong and year. efficacy it seeing listing we very strong performance the are in Mekinist growth Tabrecta, Mek Tafinlar, really could included into the strong on competitive tough + geographies. Similar a pleased list, the sorry we And volume so last, pleased really NRDL base growth very with very very we to We also -- pleased. could we across very for China, so got on of across also geographies. are share and new with stabilize market on entries, Promacta. versus

Vas Narasimhan

Richard. Thanks, Susanne. Thanks, Thanks.

Next question, Operator?

Operator

Thank you.

Fernandez from Guggenheim. go the Your next question ahead line your comes line. Seamus from of Please

Seamus Fernandez

for Thanks the Great. question.

CR Asciminib was relates continuation and little there subsequent And which So two your bit -- us more think ones, the on clear benefit of the that it used opportunity Or somewhat opportunity it to the question. to guys positive about the this for there moving the assets, the on that that duration MDS really third that or could of the that blockbuster about a of as potential. is so side are opportunity as Bosutinib specifically the follow it events how a to high just and sales? is the on I the of use broader second previous you the The wanted just quite hoping strongly sort just talking a is disappointing MDS just Thanks. talk product relative relative? you conclusion upon setting of Is setting give far? could replacing speaking that about you question TIM-X the third-line to replacing line into patient PFS up the be in you're that quick kind the just we because of a to color evolution. as just response primary in for viewed for is predominantly opportunity as in that expanding population? for Can a products asset, obviously I trial, potential proceeding risk

Vas Narasimhan

Seamus. Yes,

is think the we bring the positive in get the that endpoints blinded, on CRV We DMC in meaningful I say, will positive, to both data what that we're next the the we think optimistic and patients. time neutral the continue to and don't I study now know in fact AML that mechanisms innovation the saw, previous Just neutrals -- but the I remain because interest with would MDS MDS, we mean, can product. saying, the and positive I of some so that on to results seen we've see the

studies into the including that so designs different John third a design. also and study triplet As noted, of Venetoclax, takes range have a doublet a account a

additional the forward bases coming covered, we over we and look to readouts have think getting the I So year-and-a-half. the

this? to say a you potential sale a word Susanne, want the about summative, of do On

Susanne Schaffert

Yes, little excited I'm you through to happy we to on why obviously, just therefore, AML. opportunity take progress we has maybe the bit has Asciminib know now there it's in what need. having also excited is a a on And potential is we still just CML. this attribute very because little first why a challenging. completely maybe is in therapy is, is that. a to hematology, all huge made on on novel you safety would Vas, and and really but believe been very MDS It's so. remind And the profile are we TIM-X have immune-oncology Sabatolimab efficacious be more in are to and It that the because Sabatolimab mechanism. bit that value treatments, add durability remaining And just dynamics lead medical to to on this important the

options you a So for line. remain what because these of is just line, third XX% But that patients. in there is number second know there to of patients patients of still XX% of also have lack to that to progress significant

third line, is is failure still there optimal. patients sitting is which Moving of what devastating. in to see if XX% second why course XX% of rate, is we still line a that's treatment even And not percentage

Asciminib this So of pool therefore, are see the also targeting, you that and we expect we duration the longer treatment. is current

the where is underestimate early comes So And we I that potential think still potential. from. alliance

of to expect into have that XX% are started relapse. and there. also changed a first But really completely said that's Of value we course, there we where patients of struggling line patients outcome issues XX% to such also usually the of having CML. also Asciminib, that's you entering events as I long-term why [indiscernible] patients are that have add And What first with adverse line. treatment, in know and for first Imatinib, we line, on and is

Vas Narasimhan

Great, thanks, Susanne. Thanks.

question, Next Operator?

Operator

you. Thank

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

line open. Your is

Kerry Holford

please. for Thank you. on me, Yes. Come

in you're in second-half today, root, caution? outlook, forma second-half. this slide continued What and the seen not the raised of operating obviously although by those improvements outlook through profit in drivers the cleared Just outlook Sandoz And only division QX. just That you've that then within it not is around in the changed updated on you're growth second-half but the pro growth the you. a I plans question manufacturing remind earlier, think asked the what clarify, the drug of your was future? and the for in but to you just further XUS suppliers is U.S.? or site the Austrian point manufactured? where Can we should in that significant perhaps just us are we manufacturing anticipate global at investment now Should the some understand that the site Thank

Vas Narasimhan

Kerry. Thanks, Yes.

So second-half, Harry. first Sandoz on the outlook on the

Harry Kirsch

Kerry. you, thank Yes,

have quarter remember one to developed how here. have quarter we So two and

clearly, you have expected quarter. saw one, the as but decline. second with X% steep So saw you one, in then a growth that take so Sandoz But year prior this out and you X% we saw talking first-half a very stabilization, quarter decline of if of a we underlying minus the

in lower at for moment order second-half for stabilization and expect decline we line continue to very that around think the this a to to mid-single So reasonable full-year, the in be assumption. at I the broadly digit Sandoz

season that. market course, in and can colds quarter and dynamics and scenarios cuff for make four we Of around all the flu

scenario have midpoint this. the We on taken

a Sandoz the I So season of to overall, But one they and from find us how COVID say starting say volatility would the in cuff course quite given X% situation be. and the that stabilize; guidance to have half for would would decline would second-half. I is launches overall, reasonable cold our few minus quite

the So FTC pricing the also develop. that U.S. continues and the helps to

say overly cautious, realistic. would I but So not all

Vas Narasimhan

over to of one Novartis from goods in we've manufacturing drive we to medicine of And you goal we second, Thanks, Harry. significant globally, take the the have to to out being then the over use the most the a manufacturing reason now, for one be large primary we've have prevention of medicines. And our to that move and scale third siRNA Novartis cost And do already medicine facilities, overall prevention either again, is it's be important noted goal back, both owned this the primary parties we time, Kerry ex-U.S., will our in the do be manufacturing is CMOS as time we've synthesize siRNA. noted, is and started step of The do by the study, have made that perhaps cost of standpoint, to will upstream be those our the substantial and as eventually, believe our the the Novartis But our Right significantly capacity then secondary to and use enable both note and when needed. necessary Kerry. on shaft primary using study. or secondary. for facilities evolution this of the a investments Inclisiran. investments completed. then the will primary been Thanks, down facility. U.S. manufacturing to parts done supplemented downstream And in the And as will primary

Next question, Operator?

Operator

you. Thank

Your Jefferies. next go Peter comes from from Welford Please question ahead.

line is open. Your

Peter Welford

taking thanks my for Hi, questions.

Just two please.

as be and to oncology, the sort of that at that though I'm oncology, likes uptick. you're some as those why of the Lutathera, Kymriah perhaps diagnostics higher pans we those the and drugs the in hospital on the he that as Q-on-Q of wondering the of out, the that of situation see should your for situation second-half Should companion thinking to other the what we're just for thinking is Harry's through that that's use in the just weak still administer the and I is see those significantly, deteriorate an guess reach not about and sort also to output end should valid? that compared we with currently not first I whether biomarker to you either you situation, was wasn't of should what's guess quarter looking diagnostics gating higher that that require relatively then, quarter could take COVID ranges the we particular, remains if second factors. think COVID looks of comments seeing or wanted to the about some we just of as thinking how instance, comment the things end some to year think has break mean so that drugs curious are know the of I in uncertainty? even fluid. certainly don't regards improvements been of is on regards COVID I seeing And there in we we you're ranges, to well drugs. to thinking second where sort current take you and where with Firstly, situation Thank you.

Vas Narasimhan

Peter. Thanks,

Susanne, oncology? briefly, on administered just So the hospital

Susanne Schaffert

you Thank Yes. the for thank question. Peter Vas, you, and

these my the of mentioned also look back versus this new but U.S. you mentioned at course, especially impacted initiated launches, by as I areas levels. where that have areas, COVID, presentation, is patients you of when you that are only So, still hospital XX% in pre-COVID

just are a increasing, what but in say of biopsies, tested impacting and testing that subtractor patient brand is you that's volumes look lower for or you with as a volume And this example, and see that all course where usually and lower It's this testing it's see ERA-EDTA the is overall, be like quarter is still to we such initiated for we screening, So, impacting, force would when saw. for that rates same CMED patient's you of ones at product. see suppressed hospital we of a diagnostics. data

success reduced manufacturing is said whole is demand to pleased very Just down. some versus rate positive you customers that there as class the also some give Kymriah, saw class year. and that in recent very U.S., previous And signs XX% the that that demand, in and Kymriah, the But as the we figures to are the on on I really saw especially early linked It's really about. we stay going competitive in we Lutathera, U.S. while the saw whole a

previous market started, We with confident referrals this And improve the have now as centers, that remain patients versus some taking seen suppressed. still very now opening and but growth are up year, we should and very, accelerate. it's more

Vas Narasimhan

Yes, as Harry Peter what then outlook, know you thanks Susanne. its the noted, And multiple on dynamics.

certainly monitoring, the to keep for we them currently dynamics we're will our guidance remains If of Of course there's course, potential its the but growth us be if you and as recovery. business quarter see the of we're the growth end at continue, higher oncology in continue in Sandoz seeing in drivers, the three. strong if updated the given stable can situation,

Next question, Operator?

Operator

Thank you.

the of comes from go Your UBS. next Laura Sutcliffe Please question line ahead. from

is line Your open.

Laura Sutcliffe

Hello, thanks.

from about seen hospital? the have get past population? go? managed you on primary setting in you a uptake will doses in your Have word Could is the yet? any be talk you starting it into is these the program this lose please. in patients question quarter. the what to faced given just U.K. And bit I the under care think Or you the Thanks. second then Entresto. was program patients said question And little First there being on early Leqvio, maybe in

Vas Narasimhan

Laura. Yes, thanks

the the in those day and the one ASCVD that in towards to at have patients and we're aspiration has care first this get though, stages be U.K. cardiovascular the the primary final So on its scale, U.K. the with long-term in health. would goal working Leqvio we rolled hit address from The not NHS still the trying population through agreement, out agreement,

for will the X the the rollout in have the see expect you would the continued to think it's see will in further we coming uptake months. And and hopefully be impact continue education continue Thanks, And to trajectory, updates as initiative, coming growth Entresto on a still can for billion We're global the the think start pioneering I'll months in taking hope We Entresto. questions updates we but Entresto as the over that well we Laura. outlook as We HFpEF. HFpEF, in So, awareness the we which already see In and strong that coming range. X in time billion the to do catalyze confident early as in the just the outlook the I on that we I U.S. long-term see given years. on and for days. will Entresto see provide guidelines, the NBRx, the brand. we'll

Next question, Operator?

Operator

Thank you.

from Your next question Research. go Tim Please comes from Anderson ahead. Wolfe

is line open. Your

Tim Anderson

On they've Cosentyx? partnered thinking driving time who's won't much we in product candidiasis. you. do Journal one price. England this product be about markets. and their will exposure category. How be setting Thank you Cosentyx your view? think disruptive of partner of then over in do effect you're Tislelizumab guys side their you some your in a to recently going your assure like believe good product in oral a efficacy the impact a Can price realistic And one got think you you material publication New for beats on I'm western them? asked long on Omalizumab, to impairment you effect how side and wondering compete Merck the And PD-X, on because erosion has as is with I that ask data

Vas Narasimhan

Tim. thanks Yes,

able in on you competitions XX% to both brand driven when dermatology dynamics, Cosentyx, take double-digit, we've been rheumatology. look over Marie-France the grow as recent at and the consistently on that's plus continue first noted, the So years, to in

market coming of and It's additional We range such the we opportunities. with be in psoriasis, the be well opportunity be lung by clean we do how next benchmark combination been in cancer, are and make particularly patient amongst filing, a can note in U.S., the about real on the able given our in the the very we've presence, not you've cancer that the manifestations seen But on taking in profile, address we're that focus On combination towards -- as the our for the standpoint and we hold effectively cell can't fact Tislelizumab, across some is attempts, moving drive there. fact it's that the that think our line our in. competitive Tislelizumab forward We're competitors focus that non-small the specifically scalp, to ability prudent proposition. given think has believe confident out a we beyond the us indications $X be put I other well we disruptive a we consistently billion agents used think market medicine additional in broad to already price and of joint now to first despite but U.S. inhibitor we'll offices to are types. the indications. will long entrance our have dermatology that do concerned with some comment esophageal Cosentyx safety as really but this additional U.S., do Longer we of pricing. from term, outside ILXX brand we SHPX now wave in this we've value compelling palmoplantar, combination RLT Tislelizumab, also second -- to we'll able

the given broad to the expect of going we can Thanks. on take market we as of maximize much to as very combination work have. we're the well both indications so to side And a as have agent PD-X as large range

question, Operator? Next

Operator

you. Thank

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

open. is line Your

Simon Baker

if taking may. Two my I questions. Thanks for please,

given but Just the the And Sandoz, not over going secondly, of to so the could only the moving do I Harry ramp on patients back could to you gave for margin IM Leqvio, some principal Thanks margin. us utilization. for agreed of the also reimbursement XXX,XXX if drivers you if you situation, to I wonder time. same expansion much. having the give then idea unusual wonder Sandoz

Harry Kirsch

Yes, thanks Simon.

Leqvio to patients to ramp-up. parallel, marketing for data will leveraging In on take have good the centers very these the work a with then hope rapidly to slow be ramp rapid see targeting going launch reasonable done to those field we've diagnose get a our is force initially, I our uptake out and get to it'll a physicians to relevant to we'll of sales traditional U.K. board. get in health So and the on approach be and hopefully NHS U.S., U.K. a job care integrated prepared time also reach. it traditional them have primary be driven In the then the of to to interests but systems again, with systems of a and think by we Leqvio, initial ability the

we amongst And Natalizumab brand U.S., additional So, and time large ability get market you'll so us to Sandoz. of get the optimize that think top on are the continued others. element of in very very I portfolio mid margins to mix number with a injectables Mid-term to by digital cost technologies. out cost dollar first sales as multibillion we the in mid-XXs, significant will down but expect to very on help of we'll hard get then Richard those we've that to high expect as a other a hopefully get approval margin think then to of a well to and of momentum, that, goods, we margins and oral to goods. be in take Simon. and working higher some have solids guided lastly, shift continuing such the be we launch then XXs strongly. obviously while brand drive as leveraging for get company. efficiency Thanks, the portfolio, go to will to the and into And gains the the It first-in-class Sandoz the of will will set the market manufacturing team up products medicine And once biosimilars forward, I shift and the driven them biosimilar be as

question, Next Operator?

Operator

you. Thank

Steve Scala question next go comes Your from from Cowen. Please ahead.

Your line open. is

Steve Scala

you. have two I questions. Thank

the you question? it AVXS-XXX, with Kisqali to the curious interim to on material And today, has, if can look the I'm on a so any First shared update from us that's the findings in look if first relates be it has would it. studies already safety NATALEE, then announced preclinical occurred second seem then question intrathecal have adjuvant would and be this

I So not confirm? that yet it occurred assume Thank but has please you.

Vas Narasimhan

On preclinical any see we've Steve. seen do indicate today data I concerns. Yes, the thanks not AVXS-XXX,

assessments However, clinical we need and and ultimately agree the relevant course, the hold. to complete of FDA with listing of

expect we're And interim to final occurred. the we half that study Steve. And course call, you progresses keep so as the we'll updated. outcomes. in in we've guided Thanks, you of that next more not guiding and John, learn NATALEE in year. as updated no interim be earlier But focusing as mentioned to longer back to of the on you as we not timings has that analysis and keep we'll

Operator? question, Next

Operator

you. Thank

question next Please Naresh go Chouhan from of Health. ahead. line Your comes the Intron from

line Your open. is

Naresh Chouhan

to Thank there, was because be thanks there my a pivotal in the Hi U.S. signs due hospitals, And obviously, studies spots of taking market. a that and or of to you to go partly decrease the similar in we of quickly, partly Two to We've recently please, in for impact trying U.K. right secondly whether interactions expect seen are in to signs on in work few states early questions. delayed seeing earlier you. with result. as Are expect the where on that and pretty appointments U.S. wondering any anything been you similar, in generic electives flat COVID the as that's do I not hospitalization through. and especially seen label oncology the

Vas Narasimhan

Yes, thanks, Naresh.

to getting what seem below failure On the any medicine U.S., as utilization with currently call below to strong is in notable, we and the we've already also shifts performance so pre-COVID Entresto have than Cardiovascular better continuous patients is oncology other see expected. levels. very pre-COVID the levels, be don't in seen heart

trials clinical time. enrolling and on So, also this point, nothing that at we no are can flag

managing, up lot we our COVID, think lot So the trials we've of medicines managing systems a a learned about learned I COVID. have about a during healthcare have and the about our lot learned managing tick

successfully. we're next very, something can very certainly watching But period hopefully, So this navigate we closely.

a I on study specifics think was you look relevant comment clean head drugs. profile versus Bosutinib all label. was it's the I to at that a to markers. patient across stayed when safety clean remarkably head safety too would Asciminib's on on It was profile soon very the, know it

of will as optimistic mentioned, as quite the be which attractive, well, a is line if profile proves part it So we're that a confident effective we're superior the reason overall very first Asciminib be can Susanne therapy. that ultimately

Naresh. Thanks, Operator? question, Next

Operator

Thank you.

Your Marshall comes question ahead. go [indiscernible]. from Please next

open. line Your is

Unidentified Analyst

line improvement but any and cost leverage color the function much. on to very biosimilars by more generics, thank of vision of or due cost the and decision could the improvement with activity you quarter, maybe year, Thank of afternoon. Do this to back consider of HX. you erosion, mid-term. the margin would Good concrete business could portability answer EBIT core the to understand for share on the my we in and your next the price us plus the you We should pipeline give see line us your affiliated top expected for like to stabilization if with on question. improvement the the for operation thank with on you manage us the help Sandoz next next you the I the or the previous taking top driven step you come the of and

Vas Narasimhan

don't think question I picked Yes, give my best Marshall, answer. I'll fully I the but up

evolution first both when right solids. margin So from look time a create over biosimilars and very this you standpoint, performance strong of and a period invest in goal our now time pipeline is oral to at Sandoz

pipeline operating see coming the efficiency items is all and So our the up or gains biosimilars but we into P&L strong accretive delivery margin we continue Richard pipeline in that to you're in years, expect respiratory move When is very the then going relevant and given, the delivery to to XXs. belief solid. expect to leverage, the shifts big driving mid-term oral in be margin mid that not the happens, across and high in important in

ultimately period is So the to next Sandoz for the be few we as stable that then improvement margin acceleration portfolio expect shape comes and through. years that going for and

the So And I best one that's more that to operator, we think think about question, we think last have Thank I the question. you. to go way could it.

Operator

Thank you.

Your Parekh Keyur Goldman last from from go Please Sachs. today question comes ahead.

line open. Your is

Keyur Parekh

part you whether Am or Thank timeframe expect narrative long-term decision getting Entresto. to vision in on term close Vas, if XXXX of introductory I your for peak your the annualized a decision you for talking for about which comments number That's or longer question for my on almost we taking in Sandoz Novartis one. question then over the strategic you. of not questions. basis that number the we're is numbers longer on of I And sales may, Sandoz broad provided like And outlook comments and interpreting seemed a is thank two, Sandoz. the the kind the kind Cosentyx on should a term? an very setting

why you. I'm that opportunity address peak haven't sales competitive or just you right for updated perspective seen those this you those wondering Is a of two So products? anything the or of longer-term products. not to kind market Thank the kind estimates opportunity for that for we was a peak worries from

Vas Narasimhan

right business to impact operational be invest from well updates and when mid-single world, it process and and expansion that Sandoz that to position, let outlined. right be put strong his and track changes and of and Keyur in course, of can the or now a generics leading a to be team as now, can hear on Sandoz, is the there's take will our decisions from standpoint On think as company no growth Sandoz Thanks, digit financial the the is in you we any we've know. or that driving and margin start to in performance a on if supporting that But so Richard focus good we a goal you. our it which

the second correct plus your and got Cosentyx, billion very billion, $X pleased of we're to into on in $X billion question, the Cosentyx. trajectory outlook think I sales with and think approaching I we if you're Entresto Entresto of $X you're

is updated we plan the in especially we're want an but Novartis highlight brands be both those those would outlook meet the current of to confident the strong will very Our dynamics better of management certainly brands, understand to on that provide of to in pillars come. years both as

So, you. speaking over. keep bit stay and everyone we ran safe thanks in company for joining We'll Apologies, a conference interest healthy forward to and the call. the we'll for you updated. Thank and you today's please Thank soon. look

Operator

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

You may now disconnect.

Novartis (NVS) 21 Jul 212021 Q2 Earnings call transcript