Merck & Co. (MRK) 27 Apr 232023 Q1 Earnings call transcript

Thank you for standing by. Welcome to the Merck & Company Q1 Sales and Earnings Conference Call. [Operator Instructions] This call is being recorded.

If you have any objections, you may disconnect at this time.

I would now like to turn the call over to Mr. Investor President, Vice Dannenbaum, Relations. Peter begin. Sir, you may

Merck's Thank Conference XXXX to you, good morning. and First Call. Quarter Welcome

Speaking on and today's Chief call Labs. will be Rob Caroline President Merck Chief Li, Executive Davis, Litchfield, Financial Dean Officer; Dr. of Research Officer; Chairman and

I'd get point to started, items. out Before few like we a

You our items. results we such and as in that will costs other items acquisition-related certain see have GAAP charges, restructuring

release. based reconciliation make I statements subject from note differ current and like those our inaccurate excluded non-GAAP on Merck's in management the U.S. assumptions in significant our actual provision the that our to statements provide and of that results be safe the may should you materially press XXXX. You Securities remind Private of of Reform forward-looking these made Act a beliefs are would Litigation the and to the uncertainties that today we materialize, prove results of of meaning the within harbor underlying considered from uncertainties. have risks or some forward-looking may we If statements. forth are Such set statements

actual statements Our could identify certain publicly any statements made cautionary including undertakes obligation XXXX cause Merck the no XX-K, projected SEC factors forward-looking materially to and update the of Item filings, risk from differ our forward-looking XA and results statements. company's those any to that in this morning.

Merck's prepared our the today's During to filings These today's section all prepared SEC call, our speakers' along Relations remarks. and are with Investor a accompany will earnings of remarks presentation slides, the release, slide website. posted

the call like to to over With turn Rob. that, I'd

forward I pipeline today's of very and began pleased the our thank We advancements with and with growth of strong consistency with Thanks, Peter. performance our continued across drivers. XXXX of key call. our key morning, excellence and for lives bold confident remain serious needs success. in significant you joining which areas and solutions, Good shared science sustainable world. bring address I'm importantly, the We strategy that is unmet that our improve and save purpose around execution, grounded remain to delivered team's our medical leading to and

development capabilities. science-led pipeline for performance targeted consistent. XXXX Our term. forward we're financial momentum in confident discovery our and to and strategic focusing this priorities lead we business We to value and internal shareholders important aim on leveraging intend accessing as will sustain the patients bring via from complementary innovation strategy, the most our our long well beyond, the development remain clinical and to science, at external best-in-class pipeline compelling By commercial that creation strong over and in and as our

ulcerative important is also a revenue that enables a of presence decade. through disease, Prometheus from broader accessing Biosciences. pipeline when science This approach. our and we're in decisively and treatment and another suffering growth of us of increases It platform acting that a us could example diversity care with driver as best-in-class as standard the potentially for of very accelerates acquisition patients align. transaction technology Speaking announced debilitating the conditions potential pleased our novel the brings potentially brings medicine Prometheus innovation, of immunology, transform Crohn's pipeline and significant well external a colitis next precision a value Merck our

LAGEVRIO to across and and for the of vaccines. These the in outlook moment. sales. excluding We key oncology now XXXX, in a innovative to in Caroline strength robust growth remainder for in year-over-year our the particularly momentum portfolio confidence which our our and will reinforce reflects underlying results. expected Turning first growth, results fundamental demand speak our significant very our continued delivered quarter drivers This in decline

in at the March. research we this The the our sotatercept Cardiology change Conference new shared cardiovascular, for our remarkable patients. trial pulmonary the STELLAR the belief research College the important to In work reinforces studying arterial advancements. of hypertension of organization. Phase potential in We've our paradigm treatment to strength in data colleagues from Moving of made X significant American mechanisms

In a results oral the that for suggests trial addition, of PCSKX X LDL-cholesterol in treatment studying our accessible this could globally Phase inhibitor need patients from impressive option be reduction.

disease achieving these cardiovascular legacy the our are long-term belief will we of build growth. successes therapies contribute programs for The forth from significantly across pipeline Merck across its and benefit excitement patients have created suffering company bringing strong will that breakthrough a and our cardiovascular that to our of on

improvement certain In oncology, cancer, significant KEYNOTE-XXX, forward we positive with which we later in in and pleased non-small were to showed survival approval year. from lung look early-stage to share patients top a this results event-free potential line the cell

with working expand personalized KEYTRUDA cancer partner, vaccine our which are therapy study tumor of the efforts individualized rapidly a neoantigen to referred to we addition, therapy, adjuvant previously In our additional an with Moderna to we potential types. melanoma and combination as in

progress recent working the by our now and of substantial any broad areas in a number years. encouraged therapeutic We're pipeline. on more greater programs than at across time late-stage made across very we've modalities I'm

engine always begun as our even move decade. next scientific, sustainable strong to and patients the the dedication our across speed I we've team need growth we with proud operational and into a deliver summary, will their do I'm both recognize with and urgency year XXXX steadfast want Human global progress the more. commercial value thank innovation we've Health of that Animal shareholders full In expect to made, build to for but momentum well businesses. for and as and

that, call turn the With I'll Caroline. over to

Rob. you, Thank morning. Good

our with key start pillars. but our our further results innovation demonstrate to to across of These off growth and focus are on science as strategy the robust core strong we highlighted, the year Rob working. As performance underlying is a

excellent team delivering our the Our success vaccines execution globe. and people by important dedicated animals to is the enabled who colleagues are medicines of our and of across

to disciplined long-term for very remain shareholders. make deliver continue to patients our in value while investments We maximize confident term short and the we to ability in

were Total Now turning quarter company revenues billion. to our first $XX.X results.

LAGEVRIO on basis. exchange impact delivered business foreign growth Excluding comments of underlying very and XX%. ex from of remainder the The an exchange, will the my revenue strong be

momentum, health human its driven growth and vaccines. business oncology strong excluding was Our by XX%, continued LAGEVRIO,

Health solid by and Our products. also Animal driven delivered animal increasing sales across X% companion growth livestock performance business and both with

quarter our in cancers. from types to well early-stage by In cell the earlier U.S., including stage continues demand KEYTRUDA to breast in carcinoma global as benefit and In across types by key of tumor triple-negative uptake as all the renal KEYTRUDA key well driven and cancer first billion, certain robust melanoma. turning as in cancers, performance grew oncology, metastatic utilization brands. to of indications Now approvals XX% grew driven $X.X as increased for

treatment and for to continue uptake along we diagnosed screenings low level We, with earlier in cancer upon receiving others, over surgery. as anticipate We to also from will patients rates are the gradual lung working community anticipate diagnosis are working improve of we KEYNOTE-XXX which cancer stage follow-up medical with increase adjuvant to time. through the lung increase

by the far. encouraged received are feedback thus positive We

by well cancer. in Furthermore, to positive results to potential treatment we us excited Together, our bring non-small KEYNOTE-XXX studies extend option additional an of position cell leadership patients these study. to lung the are the following the

approval certain adult the look providing forward recent of option patients with KEYNOTE-XXX. treatment to also cancer bladder new We to a following

cancer leadership breast as uptake types carcinoma in of high-risk earlier KEYTRUDA well neck and additional certain continues lung continues which markets. metastatic Outside including by stage launch cell its certain non-small driven to to early-stage the renal and head as cancer. cancers, types maintain was triple-negative cell U.S., of in in in Growth cancer,

Lenvima due carcinoma X%, market-leading increased remains the uptake ovarian primarily cancer. European Alliance patients to inhibitor. PARP due certain grew in key cell in X% the certain markets. revenue key Lynparza to revenue treatment in alliance of in renal grew advanced European markets patients with with increased demand

and as portfolio Growth growth from to XX% grew from acceleration the benefited well the meet by ex-U.S. Performance led China of which of markets shipments demand X of year second product demand major vaccines billion. years half GARDASILX particularly availability excellent Our delivered as strong for supply. girls first increased the to indication an heightened women, $X half the to in expanded ensure the to also XX was to of the following of GARDASIL, driven approval by to age. China of

the following launch, U.S. ongoing Vaccine the particularly the pediatric from increasing VAXNEUVANCE sales demand for benefited in also

driven hospital portfolio, sales increase our care acute agents. neuromuscular BRIDION XX%, an in by market grew In reversal share blockade among

another quarter sales ruminant and delivered good actions. reflecting across increasing our well with business price Health demand particularly Animal portfolio, X%, as as strategic strong poultry Our in livestock products

P&L, increase of on Imago of my and X.X the XX.X%, reflecting with was benefit a lower and to of now collaboration be the due of basis. and a Gross mix, related an charges increased will license walk comments you which billion, the will expenses product to favorable of percentage from remainder I margin points Kelun. our through LAGEVRIO. to acquisition reflects Operating $X.X billion our agreement $X.X sales non-GAAP

grew by driven expenses increased operating our to charges, XX% these investments pipeline. growth and key drivers Excluding support

Other income $XX million. was

Our transaction, tax the recognized. unfavorable tax impact which from XX.X%, Imago rate for the reflecting was benefit was no

acquisition Kelun. share, agreement from includes with impact and a Imago earned which Taken we to $X.XX related $X.XX per of together, charges the our

full revenue billion to us LAGEVRIO. Turning to narrow billion, operational now now $X $XX.X continued and guidance. business from project our raise to approximately our billion XXXX be The year $XX.X strength of our non-GAAP guidance. including revenue and enables We between

impact LAGEVRIO the and to exchange foreign X an We using growth rates. from of point XX%, decline expect approximate X% strong percentage underlying negative revenue by in mid-April offset

is Our still gross expected to approximately XX%. margin be

and of narrowed between to be operating billion estimated $XX.X have We $XX.X the expenses range billion.

our Kelun. reminder, not any This to development proposed this acquisition As range upfront the and business research potential billion guidance Imago related significant expenses or with of Prometheus of includes $X.X agreement does and transactions. development additional the of assume acquisition a

approximately $XXX is Other million. to anticipated income be

full a approximately billion XX% to year shares continue XX% rate and X.XX outstanding. We tax between assume and

using proposed of of and from year. exchange together, rates. is a that important EPS note $X.XX. expected which this narrowing includes percentage expected to this acquisition negative to range to we of third not approximately X impact is impact are It This of Taken increasing $X.XX the in to guidance include does mid-April the Prometheus, points, range the our close foreign quarter

charge We in non-GAAP both or that charge expect result our research $XX.X of GAAP in billion, will reflected approximately and this will and per one-time increase of be will a expense approximately the The results. share. development impact $X transaction

financing $X.XX pipeline will In by impact months addition, the of negatively the EPS cost as approximately as advance in first to following the close. ongoing XX investment well assets

compelling that this As shareholders. to value potential meaningful Rob excited very confident we and the has and create for patients by are noted, Prometheus’ transaction science

by guidance and Our business Animal the key our in Health. reflects confidence driven our pillars our underlying strength in of Oncology, continued Vaccines,

triple in over the growth items exceptional quarters negative has launches, consider breast models, mind. you by achieved In the there a as particularly past your indications, As recent few cancer. to are in U.S., early-stage several such KEYTRUDA keep driven

to While in for U.S., will anticipate to markets, new particularly stage to expect these continue we Outside continue volume strong growth anniversary growth increasing as the launch indications ex-U.S. earlier which very KEYTRUDA; rate strong is expected initial their key year-over-year moderate headwind, we as indications, growth. the growth from an European temper is we pricing however, uptake. we

Finally, we strong of particularly are to GARDASIL, markets. growth drive ability our confident international in in

the many relative for global same year this people positioned to are growth GARDASIL We quite to of level from though acceleration XXXX strong of the we demand at more the full quarter. not and long-term the the see cancers growth well achieved an HPV-related over protect vaccine, for now XXXX, given in and

the following to priorities capital Prometheus. where remain acquire to Now committed allocation, shifting announcement our we to

prioritize to near and ability plan grade to dividend, we Business high within remains forward. over value and in the committed We to continue a see. pursue maintain transactions many of going time. will to remain our driven, and opportunities investment our additional, We our the credit development the and long-term pipeline science investments priority, strong growing realize to enhancing business increase it rating we value

a execute year. share modest this repurchases to of continue level will We

To conclude, for the global in very our the we driven outlook business our vaccines. remain demand confident innovative by of and medicines

future. the execution strength, value and excellent will and us are well patients in of a financial our operational to continued and We deliver shareholders enable to into position

With call over now to turn the like to that, I’d Dean.

immunology will Caroline. everyone. progress recently provide you, with Prometheus. notable since updates our cardiovascular in Today, of earnings Thank oncology, I starting subsequently with then acquisition disease, last call, and announced infectious Hello, our the disease

as presented. World Xb with As results Phase pulmonary were Cardiology Congress the from College mentioned data of at in from trial hypertension, candidate, our evaluating Cardiology well American of STELLAR conjunction hypercholesterolemia, trial, sotatercept New development X for in Phase the in earlier, Rob treatment for Orleans, as for arterial inhibitor the PCSKX oral meeting of MK-XXXX, the the

therapy, secondary combination background met combination In The sotatercept, primary STELLAR with distance its at in the weeks endpoint X-minute to substantial XX placebo with background in a in placebo. X compared were Journal measures, of met X study, time Medicine. a improvement in therapy. stable compelling clinical with out walk reduction also to These New versus or England trial findings simultaneously including the death of worsening in published

from working filings the year are and at agencies EU. anticipate the the diligently submit U.S. the of STELLAR filing to to this We third by quarter this data in in time, regulatory followed

access. could were global for We the sotatercept broad patients to including and HYPERION, at trials levels placebo. detailed actively are reach from XX% versus able program, a the An highest presented PCSKX provide the were receiving goal. LDL-cholesterol SOTERIA inhibitor X XX.X recruiting. ACC to MK-XXXX Up up of showing Phase ZENITH, Also to for are CADENCE the LDL-C of advancing opportunity dose which XX.X% their broad, Xb results at MK-XXXX, Phase reduction studied, the meeting, oral

initiating are with and including In we familial in high-risk hypercholesterolemia. primary conduct trial. studies X patients secondary will cardiovascular parallel, multiple for outcomes intermediate to We prevention; Phase heterozygous prevention; a

We with diseases cardiovascular are improve providing and our to look developing and that updates medicines towards the of making of in extend lives goal future. the patients forward progress

oncology. to Turning

to cell have the We there where non-small from platinum stages FDA mentioned the doublet key in earlier underscores ASCO findings PDUFA KEYLYNK-XXX. will of an patients KEYNOTE-XXX set detailed the Relevant lung on stage comprehensive a Together, with action presented there previously, cancer non-small cancer, to based date the significant is need. study. we on adjuvant in area be of date neoadjuvant, to adjuvant where lung combination II, ongoing and development area patient patients announced approval with have focus of IIIA of therapy KEYTRUDA certain unmet our at include and builds in This the improve for wealth data program, studies been and with cancer, findings as has treatments generated. has The IIIB KEYNOTE-XXX, October for with KEYNOTE-XXX of study Agency outcomes. additional I in KEYNOTE-XXX our resectable on opportunity by based As and execution acceptance setting significant for application followed of the of June. XXth remains development KEYTRUDA commitment a the chemotherapy cell

for early also through detection cancer reinforces it need lung screening. Importantly, the

detailed and Cancer the announced with combination a for treatment Association in meeting, study stage VXXX following American known annual evaluating in neoantigen disease melanoma high KEYNOTE-XXX, risk Xb an in the At complete as resection. collaboration recurrence also adjuvant with KEYTRUDA we Research Phase patients III Moderna, individualized results with IV from of mRNA-XXXX, for therapy, of

resection. results that has high-risk of Designation of potential over melanoma, first PD-X to Therapy are year, Breakthrough initiate Merck rapidly the provide this standard Phase These following complete improvement and therapy and has adjuvant types, X neoantigen demonstrate European additional cell study resected melanoma individualized and cancer. non-small care III high-risk evidence to and this to first including Moderna lung for randomized combination survival and recurrence-free a PRIME blockade an in FDA melanoma The Medicines IV adjuvant designation in the Agency expand the benefit. stage tumor awarded has granted plan

urothelial foundational evaluating This evidence the with carcinoma with U.S. agents. Astellas drug KEYTRUDA not for who advanced this accelerated and enfortumab trial. chemotherapy success approval The anti-PD-X announced cisplatin-containing we Seagen, these followed conjugate antibody is vedotin, an conjugate, is work KEYNOTE-XXX with of on with combination with or eligible approval in from antibody-drug FDA’s Priority of Together an immunotherapy data Review our combination combining the adds patients. advancement adults and locally for the of combining regimen metastatic the of treatment accelerated in with in as KEYTRUDA based to and are chemotherapy. an provides This for is the anticancer approval promising important a first tissue therapy an approval targeted

of work, our a conjugates next with with Biotech. upon are positioned We to Kelun this portfolio antibody drug build generation collaboration well through

initiating in both clinical as for ADC, we and underway trials program KEYTRUDA. look MK-XXXX, TROP-X and expansive targeting monotherapy is for an our global Phase forward Planning with development combination X to

patients We expression. significant that This chemotherapy alone for on in filing metastatic the gastroesophageal improvement positive This KEYNOTE-XXX. accepted in The a in with PD-LX KEYTRUDA us results upon plus also HERX-negative or a our patients patients, overall of risk combination survival, treatment set date gastric KEYTRUDA demonstrated on based regardless chemotherapy from reducing the disease the our junction for or Phase of chemotherapy is in of has December application FDA has announced first-line agency locally advanced XXth. death opportunity with for the adenocarcinoma. approval based X PDUFA trial, of XX% compared KEYNOTE-XXX by provides unresectable with to action to expand the HERX these which

NRGGYXXX data endometrial patients the treatment for endometrial III positive on XXX. in important from chemotherapy and announced This cancer IV investigating advancement building combination recently of Phase We is recurrent for KEYTRUDA trial from X to with XXX an approvals our with with carcinoma. or women the stage KEYNOTE-XXX, first-line

Earlier on lack improved and XXXX for Society’s due cancer this to not treatment noted facts annual that over past Cancer uterine of advances. the decades report American malignancies four had year a the trends, survival

treatment and of And prostate of We cancers. an finally treatment ongoing growing provide and in options therefore a continue metastatic work our the to significant women’s unmet cancer castration-resistant commitment. area better need remains

discussion at nonsteroidal regarding from the planning insights MK-XXXX, drugs with with Phase upcoming year. important we to this our oncologic are a to study AstraZeneca, the Also, We by forward committee oral, collaboration meeting. and have X trials the date gained Orion, the studies KEYTRUDA evaluating of CYP-XXAX, inhibitor novel our initiate look advisory end of from to Lynparza PROpel and of

to our Please proud Chicago. investor development in of provide Xth the look we an event of Monday, are for at making forward evening mark we the an progress program. are ASCO your where strategy and June and will on oncology calendars hosting update We

Turning progress our to of the program. infectious disease

new We an islatravir Gilead, are enrolling with X have actively X combination Phase and, Phase study regimen resumed studies of Gilead’s combination multiple for oral doravirine islatravir now treatment and lenacapavir. with of in once-daily the once-weekly

science during Labor for world, of to of prioritize the treatment treatment Health On offer the the where approval Welfare around the access we to full recently new Japan, continue We global COVID-XX for treatment committed COVID-XX. in LAGEVRIO, options of advancing are surges including and of the HIV. Ministry to granted

with are read of viral the for other treatment infections as the LAGEVRIO of studies share will evaluation We proceeding respiratory more and out.

Finally, Prometheus. to acquisition exciting our pedigree colitis scientific a potential and Prometheus recently offers of shown strong ulcerative a in announced candidate both that Crohn’s disease. with has

clinical and dual TNF-like a of target, Phase unmet patients where disease deep bowel Crohn’s a even enable that to in standard data on biomarker implementing mechanism current developing potential novel are which therapy Merck's molecular a PRAXXX, greater opportunity the of candidate additional for Prometheus' an yielded understanding and deep properties. has biobank foundation remission. clinical to PRAXXX's of with in biomarkers, antibody, that with interim forward XA formed analysis, more of where insights IBD and Immunology efficacy suggested further often in in Further, therapies likely X we combining matched medicine expertise targets. the is, gain a the a prioritization look of first-in-class on a is sub strong knowledge care patients transform By will approach. anti-fibrotic and hope right with identification including era late-stage positive provides usher the new the inadequate both high anti-TLXA the of potential action Prometheus' PRAXXX disease deep Disease building in at ulcerative are results in discovery precision which unique remains. the insights specimens anti-inflammatory based and population need to achieve we to and and Prometheus' demonstrated inflammatory colitis efficacy. to area

our make the improve that goal of creating innovative we medicines will continue In closing, towards outcomes to patients. for progress

to back the now And Peter I call turn

demonstrated results with candidate properties. PRAXXX and both dual inflammatory Ulcerative efficacy. action, Colitis unique in clinical fibrotic including strong anti Phase of a X anti mechanism disease Crohn's and

the greater based likely new and matched We disease, biomarker at to Merck's in medicine inflammatory right era understanding with on approach. deep and interim and the expertise Prometheus' Further subpopulation even precision deep in data implementing in a are suggested immunology, an of to usher combining By analysis, a patients bowel more remission. efficacy hope achieve with positive biomarkers. patients where developing the therapy clinical

foundation biobank enable IBD of additional Prometheus's building identification molecular yielded discovery deep insights, PRAXXX and specimens gain targets. to we on and the of the of have which for that further prioritization insights to the knowledge form forward will look that

In improve towards our closing, we medicines the continue creating innovative to will for patients. make that of progress outcomes goal

turn And the now Peter. will to I call back

ask you. to for of themselves analysts you, ready Dean. the like the by the like limit to we'd question Thank Michelle, we're call hour. I'd Q&A. to complete today, to Thank top one

[Operator Morgan with Terence Stanley. Flynn Instructions]

This is [Robert Cusick] on for Terrance.

any You the and your point? PCV. are at trial Phase conducting have if the the elaborate Thanks. of partner you Can design in-house you X this trial? a basket data of on Moderna And of the

plus general This Yes. on focus new just tumors antigen going a therapy others. There of give and probably joint I that will want really Phase the a sense. just Thank through is advancing individualized in extent a Xs the that's that a KEYTRUDA is at of sort in basket you to or likely trial to I we're personalized you. melanoma can look the work. Dean.

are, and We would likely we have to a immune little bit as tumors where our prioritize basket sensitive a roadmap in trial. those of

please. Great. next Thank you, question,

is Our Seamus next Guggenheim. caller Fernandez with

this year. question is if some update Bio on may actually the Kelun previously, could believe, just later you I us, stated longer-term it was see opportunity. that So data Dean, we my hoping

see feel other could understand in or differentiated just and maybe us competitive enthusiasm from particular to for category? products you dynamics likely changed case of And product commitment? still help Just you have if if that is kind that where the the would hoping that it your if be

our dynamics programs competitive and push harder to answer make more us faster. enthusiastic just by I'll the

Xth. there in have that from on providing accepted a be ASCO data We'll but presentation it as in will well. will believe, We the ASCO, I for cancers of have investor, series the be June also an we at already data

be very an interested good first shown the that. antibody conjugates very -- TROPX in and broader therefore, many point. has indication, that, other collaboration broadly, just or not advancing but the And we a data drug may impact, with we're ADC evidence more multiple the through Seagen effect, we ADC drug as interest we're anti-PD-X and that and haven't of know, with but one not provided So this antibody as conjugates just our interested postulate one in in also fact ADCs that that with we our of

Okay.

Next question, please.

Luisa Hector from Berenberg.

if KEYTRUDA. you update wondered give us an I on could

setting from -- that you? either it's data lung the the might we in change competitor your any X and of and positioning adjuvant subcutaneous when competitor Your subcutaneous? have formulation looking against relative that how Phase how the newer your or might And former on

the early-stage lung. the me question grab just about Let

meaningful that the are response. complete pathologic in I primary study, event-free most also RCC. seen important. is really our endpoints improvement able going significant are triple-negative OS Again, do in in will significant be of be perioperative, presented endpoint also already in lung adjuvant to our emphasize seen also trial stages the in cancer. We've we of it which is as survival it a the have I melanoma. competitors would We've setting overall this we perioperative earlier is think statistically improvement I and primary June substantial. in and would but Those and a it aperture have survival in to first do to for also well. emphasize being in EFS announce as the breast the statistically and the KEYNOTE-XXX, have clinically well. that where talked, it We've seen as we've As not And

So earlier we provide to a relationship broad in stage. treatment moving the choice in forward

different all metastatic RCC, it there "more long-term, treatments stage, ability allows patients these that a earlier will triple-negative, important on to than increasingly have are to patient. to it I whether melanoma, normal" be provide innovation be lung, stay profiles In think

giving both And especially round will will so because of because us importantly, higher be to weeks our X base important believe do that that we're frequency, we think, and administration I allows And that do a be QX other also routes very pembrolizumab, gives ability important. subcu advancing with weeks patients. an of for us to a

stage seeing might And to from Luisa, actually perspective, and just good a good with off early start. is add uptake. We're a lung launch commercial I the KEYNOTE-XXX

challenge that rates As the lower. you overall know, the screening here is are

it's we So what well. a sit And for we or be going seeing going to the we we cancer. than been slower have here breast is launch as climb triple-negative today, instance, with But saw, as position once look forward, that and hopefully, as the adjuvant as, leadership we of offerings both and metastatic company with setting. be obviously, the has a -- only potential approval KEYNOTE-XXX, in well the we'll neoadjuvant

leadership drive long. to to and do to going perspective, continuing a we've that we will get So metastatic adjuvant position. that as as in us But a meaningful got the see sit long we're to for here term today, From growth setting. to this continue our we continue in opportunity obviously, hold

Great. Thank you, Luisa.

Next question, please.

Goldman with Sachs. Shibutani Chris

Great.

you And but of to PAH lot in as Prometheus strategy? PH relatedly, in are HYPERION earlier potential and well ZENITH. of have what what and that population, opportunity. terms ILD interim systemic have thinking you of with sort your readouts certainly, sotatercept, overall now have used if assets in be broad stellar a the not You the line? sclerosis about -- potential time us scope Can results, there's you line, later and remind for potential from a so, just potential For of if

some If you can thinking? just frame strategic help

vascular. distinct a other focus Yes. just disease, the primary little keep I bit would would is one of a from on forms pulmonary kind of I artery that hypertension. lung

The other one is, I could say, parenchyma. primary

separate of hypertension. kind scleroderma disease IPF those diseases like I lung from as pulmonary distinct So from and interstitial arterial like

will You're sotatercept that We important. right. believe be

STELLAR. are pushing that We with with sotatercept forward

the are to get them a HYPERION The front line. HYPERION. well of sort want trying more in situation know, don't in out, interim are advanced is lay you ZENITH, I really actually many of really it We in have There but to is analysis, more event-driven. ZENITH, as

the or We potentially how also vasodilation people thought of PAH people about believe that reshape about largely think will dilation. it treatment

SGC is reshaping mechanism active with be with think it so combination approved a sotatercept. the we're with and in mechanism signaling in the with this mechanisms that vasodilatory could in it, well important which excited the and has, think why I remodels, pathways will already vasodilatory the field other inhaled MK-XXXX that as tissue inhibitor the that's agent will we as it program, of dynamics because reshape reshape that very combination are our potentially

Great. Thank you, Chris.

question, Next please.

with Chris Schott JPMorgan.

Parikh Schott. Hardik Chris in calling for is This

question on BD the Just front. one

So is the deals you bias the portfolio? guys internal some later progress therapeutic your stage early CV when in business from priority areas, therapeutic or development you're a there have thinking and oncology, in have either a consider or that emerging maybe areas or you you or then now about deal, Prometheus when from had pipeline

Yes. No, I appreciate the question.

this it our that's pipeline. see to progress and has really starts that -- seen do of can our where a despite an and difference for move. where see It what fact recently you've in you good with both So the seeing in internal view asking we're us unchanged and think strategic do fit the we is obviously, you made made, we most And where we make a science value we aligned. the we question, unmet compelling need use to point

we business opportunities for here we continue development. to sit us are there believe to today, do As continue to

in and you internal science And see in continue about adding, where to look say, oncology. of would progress been you in where as I pipeline. we obviously, areas the great the very, are lot oncology, happening we've of with There's a therapeutic cardiovascular. seen have pleased We science immunology areas the

So seen. has been the therapeutic what's to opportunity we've been the scientific driving us areas

about versus think on the and late, team will the depend early confidence it opportunity. has the particular And scientific as we really

versus target X don't we So the other.

licensing their X, in we're X will fact commercialized talk long about continue acquisitions that near after tell deals focused spectrum. the both Although deals we of and about a talk I and We're for not lot across phase. other and area, the a We to you, the don't the full doing we strategy. term, of lot Phase the believe the building going in Phase on early do collaborations just sake we but is not our pipeline, revenue assets

phase be So to with the a it we but commercial for If there. a great, and pipeline. of opportunity, always development to it pipeline always have it have really want the go element will will by at driven look us to brings

Great, thank you.

Next please. question,

with Gould Barclays. Carter

I timing of that Rob thoughts front potentially revenues would Caroline, guess hear drugs read-through and and you guess business And and sort also, potentially in I exclusivity you of legislation also to on would on development changes how would thoughts kind love about I for as of as how well? be the guess the your Any the the be to proposed that about launching periods? shorter EU And think Europe? think potential helpful. latest how

Yes.

our bring about if is as we high-level what So to Europe new obviously, out, you where a disadvantage the are message overall look dollars in at think where that invest put to EU on innovation puts and to just we a disadvantage it continues balance, products. the and competitive Europe concerned put at at

on were changed. to we Now need elements balance, think proposed There we that that of that are be actually what support. elements were said, there

the of side to which efforts to support, the modernize made the has clearly, have the fact accelerate framework, potential the approvals. they On that regulatory simplify and some

studies that, and in was have not the that reduced comparative very or largely balances good concerning industry not the out, data you or they across about. as it launches. the doing the you're and period point is and fact states, is very much made whether you something contingent member that the exclusivity that pushed upon whether launching feel you're have we But That area for,

We're So we have we where launch that's that to implications products, think understand we about would to the can that. and people going try as need understand continue work will to make to we sure do.

We have of years is a couple put this probably in place. before

negotiation. So we to the have time do

be here because development market, As in to that make today, access to implications sit sustainable concerns Union more have an want there. business of wouldn't is perspective. I just see theme to sure is We to it's specific our strategy, from just us against our important getting important. medicines it's push European the We the a of people is to Europe general a innovation I say the business that I what

Thank Carter. Great. you,

Next question.

Research. Wolfe with Anderson Tim

China. on a GARDASIL I have question and

and shows particular the where there effect big warehouse and through uptake growth might from trails GSA contract market really on should going how consistently of while, kind the suggest a months longer-term could that couple declines. work bolus kind few of years isn't goes Is of that interpreted And not in linear. we up So for for you purchase it It of that off distributor published GARDASIL Chinese it ago linear? be contracts literally think then your it a patients. about a orders it's next it the was as

Yes.

contract, our minimum. that Just -- you been minimums. have are have in look the history so in shown at GSA contract and that well supplied And the that fact, has we the to important actually if levels it's put we over understand

forecast than in the So the still continue we cohorts isn't there a expanded history is of wouldn't to expect better move if future, opportunities we forward. do unmet population, China there's would I what to in is drive business because literal as indicative And age what's that interpret as of with penetration see in that the opportunities that the contract. to large

would that the coming GARDASIL over in I implying China interpret years. as not in decline a So

the in lives would which I add is opportunity more a from to perspective, support on and The protect vaccination, research growth provide remain gender-neutral a studies be only we could focused future. great China into thing to

Great. Thank Tim. you,

please. question, Next

Capital Markets. BMO Evan with Seigerman

be and KEYTRUDA through that Phase grow to like this deal Ma] will [Ng team oral sotatercept with the hopping assets novel LOE? is PCSKX, the X ask We enough Evan. now wanted This to for data, does on the Prometheus think the the

very a about short Yes. Obviously, time. I'll the start we take good very in we've by the period would question, progress I Evan. feel made of saying

in in you have has point feel We We to broad perspective. to as mid-XXXXs. would oncology about we've we Acceleron X to then Whether pipeline look the and the add the progress. launches $XX internal like talked from cardiovascular move generate be that timeframe, in 'XX significant So opportunity the out, sustainable strong fact the a the and -- decade. billion at as you which into the well indicated potential we as we've more made an it's with has into the 'XX growth I know, you if deal than situation have next to potential

we anything with what therapy, used development, have formally from neoantigen an of and vaccine the small personalized at lot cancer to look we the you a excluding in the Moderna. portfolio through from ADC If call molecules, what business we've brought individualized

from greater counted. that time those see in billion So of $XX assets frame. We than opportunity even same that's not

resources his longer timetable time I given do into the growth and of We're specific So we of period I today, the have progress sit progress with forward to next have and going grow here driving of looking feel, not. in short I I we and decade? at such our a that But XXXX. well on sustainable focusing want no to in I say I a we've guidance. a Dean think in as labs, am our don't team rate given we've to would is lot we or made not giving how we're progress. am the predict the position made

Great. Thank you.

Next question, please.

Citi. with Baum Andrew

impact probably how too the other parenterals in that you tied returns supporting hand, treatment a the trial for versus, and of trial in a Could short talk outcome the the longer trial that at the PCSKX, to have idea on in you least is in planned historic the time Question of IRA efficacy for Dean. some cardiovascular contending were oral your data Medicare particular, for closely to the suggesting U.S.? balance the dosed you need duration population to the

for you that much Thank very question.

emphasize to regulatory we're X active with agencies Phase relationship in First as of in just to all, the I program define we want that discussions our trial.

So that will put out there.

an grips not is field an that I PCSKX that biomarker. would and that just with thinks is with. I excellent our about emphasize interprets is XXXX think point The pathway. regulatory coming is to it It's just is an as not antibodies interdicts think how It's biomarker the that LDL exactly fact setting, of the the there the agencies. evolving I some will that the view that be an is place evolving second X just in data it discussion excellent in same how It

second The point is the you question in the that out historic previous.

fact they the had if is the to in that profound bit the But -- that that to referring longer, on to had biomarker about I little a label. would out view would many said, trial. have outcomes you're that looks the that things want full regulatory with difference are think there that studies risks think echo terms and we with short years are that, of gone they impact have one a as more I the how I point Those the like between But antibodies your you as from you a agencies impact speaking too which of is those outcomes. whatever the the view, one doesn't needs to now. go balanced maximum IRA do be can the

should that balances. patients on will have But that is, thinking trials is whatever stay impact label general my is about we forever. because we And observation we observed well. that try your are as that those X label other to the So the maximize the

Thank you, Andrew.

please. question, Next

with Mizuho. Goldstein Mara

what seemed ask arm response some for Coming also of KEYTRUDA Moderna. personalized of a arm, AACR, cancer low And other comparators? wondering to historical to monotherapy the wanted out tested KEYTRUDA the of could rate if sort are comparisons. to question on I for speak have the particularly vaccine with the the relative monotherapy that you in seen that, we therapeutics against of I'm light being

Yes.

in comparably me the agent. that own D. of monotherapy those the and that companies, I their but cross-trial also was some in always XC we issues subgroups, KEYNOTE-XXX will included is discussed general, And What those to just been say KEYNOTE-XXX the have than state had which in that else let is were between which KEYNOTE-XXX. companies arm within and disease KEYNOTE-XXX. something performed the high-risk and this So the it's do does, everyone advanced is pembrolizumab in that and more also comparison

probabilitized us given there is for the sort way stage. same to So of a

of I recall that therapy is So X. readout want vaccine This reemphasize we're an a is just arm proceeded very pembrolizumab trial has that a Merck us comfortable to seeing individualized time monotherapy or personalized that or scientifically. important development impact Moderna in and Phase that I that personalized neoantigen can a the first to this the of a the really with the just in profound with. cancer

excited we to to X Phase Phase as other we're look trials how can we advance and spool far push strategy. X to to see So that this for in melanoma up

Mara. you, Thank

Next please. question,

Umer Raffat with Evercore.

Dean, on was TIGIT, the to arm we the meet doublet not PFS. going know

PFS. the to least at you meeting So confidence that out, on is, by Phase extension, happens to your line XX% considering you And in X? a a at if shot And regulator? just plays second have the what Like speak trial? Do benefit what my triplet getting for next, wait may so is question or PFS?

just we're X to us would FDA X and So will think And those. at. the to Phase that look they're just them of in X looks That's metastatic And do say are think trials Phase that the X the provide we the ongoing. how going just those going Phase we're that thing emphasize situations. be about not advancing at sort what I advancing have I you're trials that trials speaking Phase views to of about trial. X X those I

individualized stages our series assets eyes earlier lung. we for neoantigen on of want also I It's in really where something patients. IO When but place IO-IO previously. turning an all important earlier are emphasize very But think of we about what plus about interdict will and time IO our It think here. stage. it's into to diseases relate are can in important the increasingly, people said a question therapy, strategies, We of relook to that relates that it early, I've them us both that's that, have that because for to IO we to a and especially KEYNOTE-XXX. relates said about strategies also have just It the

Thank you, Umer.

please. question, Next

Daina Graybosch with SVB Securities.

like pursuing adding combinations X Phase X to Related to early-stage going Dean, in on two it you're looks answer, TIGIT be the parallel, your previous adding and the on in your neoantigen vivo and melanoma for individualized wonder And indication? two expect other large strategy should generally? could similar in I you same to early-stage the a why add-ons goal specifically And indications? if shot therapy. taking these we two you're in talk

Yes.

just step moment. just back would a I for So

couple a Our actually contributions your do has an right? ability combinations, And impact of just into that components. base molecule to to ago, order earlier-stage years very were it's unlocked that to important you go of cancers in allows do maybe because

comfortable moving very IO-IO earlier stages. in we're our strategies So

of or that also we any I our will it of whether ADC We're do readouts whether We as and ability be of that it also is cancer an TIGIT both spaces. individualized are will would more assets, well the our neoantigen said, you and therapy. important. you say to an for trial earlier-stage KEYTRUDA, confident see doing for pembro it, and combinations desire Lynparza, whether it And very the there that to it be as as those as plus substantial. there target pembro likely patients recruit be be be is important in multiple

to to get please. two Daina. try Great. going Thank We're to more you, questions,

Colin Bristow with UBS.

is taking the Yihan our on Colin. for congrats quarter. This Thanks and question on for

on question KEYTRUDA. another So

how much of in protective you? the formulation could a afford the So terms the exclusivity strategy of KEYTRUDA of subcutaneous would

Yes.

question. the So I appreciate

we formulation as at look the and that have As focused of we where we earlier monotherapy lines look utilized, more it's at be can obviously, where subcutaneous therapy.

would adjuvant be expect route on continue based look through molecules. that what we of would adjuvant our KEYTRUDA types advance the small subcutaneous strategy tumor with and on KEYTRUDA addressable we we half of are as we as So definition as we combining to new across where what Based and those see, areas. have then multiple out, we about

Great. Final please. question, you. Thank

Trung Huynh Credit Suisse. with

one. quick a Just

in gefapixant. of a billion. product $X I about range. recently action with the single They billion sales dollar GSK interest mechanism to similar immunology, in around peak for just Given described bought your ask a wanted renewed had

your So have? perhaps you where CRL of expectations opportunity? post give gefapixant an just that you is can what's update the this us And for

with Yes, I'll that. start

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submitting analysis submission within in XXXX the additional data, have the of submitted CRL months. and analysis will then this believe in is FDA X the of that I FDA We readdresses of the in first that speaking, all on general, half that be timing additional to generally

Japan approved And the is in interest We you have given renewed to know and if as don't answer said, transaction, a it that? recent you there Caroline, Switzerland. like already would I and

very United today, that States people is this is underserved, add So chronic in have in I population one here cough. the would that just XX a

forward will to option with FDA, to But for be will that forward with drive to built. work revenue a our and market successful we should we that it's So company. look our be the bringing be an patients will need beneficial

We look Trung, you, hearing your Thank forward the engaging lot. Great. you in and you for to you and from future. Thanks all questions very today. with thank a good

you. today's call. conference This concludes Thank

You may go at ahead and disconnect time. this