MRNA - Earnings call transcript Q3 2020

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good morning. And welcome to Moderna’s Conference Call. At this time, all participants are in a listen-only mode.

Following the formal remarks, we will open the call up for your questions. Please be advised that the call is being recorded. now Relations call at I’d Talukdar, to time, Investor Head, Moderna. this turn over the Lavina At Please proceed.

Lavina Talukdar

Thank you. Financial Quarter XXXX Update. Good Moderna’s Conference the morning, Call everyone, and to discuss Results Business welcome and to Third

Stephen Executive should Chief today’s as slides our to Chief call Bancel, well Hoge, the are You morning section Medical of by Chief be the the Stéphane issued that press David this Officer; access and our our as Meline, reviewing Officer. Investors Financial we’ll Officer; Tal going Zaks, release website. President; our On our

from conference Before performance to will filings to this I new forward-looking for we no future presentation begin, the developments. We will undertake differ Act results please actual note factors Stéphane. in provide provision results over slide the information implied risk harbor now provided to important Please forward-looking that Private pursuant and revise or accompanying these could materially this result call X expressed made XXXX. our or of statements. as Litigation cause the our Reform information a call of - and statements to those SEC of obligation that Securities or or turn include safe the see of call on

Stéphane Bancel

morning three conference health reviewing to focus update remain business like and safe. Thank will I topics. hope for afternoon, in good our highlights. loved I Good good QX key you, all Lavina. would your start everyone. Thank or are on of you I ones and call. joining with you

our First, COVID-XX vaccine.

finally, key And product development our pipeline. Second, financials.

a XX,XXX study, have COVE minutes. completed Tal whom enrollment from XX% been give diverse details study you enrolled know, for our of many in the some we Phase you of will are few communities. of in X participants mRNA-XXXX. As

to very that to COVID-XX grateful and a for would the that we NIAID It trust great is a to have our for and I job for participants study high vaccine. collaboration. PPD ensure like transparency investigators. public are thank Moderna in important team for has principal and also bar and We quality in

We have reported from enrollment have study diverse reported the COVE numbers enrollment of weekly and progress weekly communities.

not we from decided representation the of overall slow various of COVE down disease given populations, burden high diverse with these these communities, are in communities. While recruit to in to process study the people more happy we the order enrollment

mRNA-XXXX adequate can to biopharma right you was the a were it an safety to down, signed for decision. to how imagine, transparency full first world run. decision slow to were not our clinicians efficacy Phase As the pledge not but data. the and could have introduction it protocol the until We we online file and approval for We the industry submit easy set regulatory early. was company have others to pleased the standard is see of in the and We COVE ensure X in study redacted around follow being full also

Moderna. Safety second We half participants DSMB month analysis continue the follow-up expect out median these in Board a inform and two analysis will dose vaccination interim We our interim carry to should XX,XXX over safety Monitoring November. first in The Data the independent of or then second readout have post-second November. to after

October the many latest their U.S. of asked published in VRBPAC of know, is guideline this you what XX the part submission As of EUA FDA as meeting. has ahead

critical not on Manufacturing the soon file EUA the FDA U.S. Control working as Chemistry available an to CMC ensure to and CMC to are approval. closely components is they with path are We as or

of Canada in eligibility Application EMA EU. the received In addition Marketing to confirmation ongoing with the of rolling and to submission submissions the U.K. we mRNA-XXXX the and for FDA, Authorization for announced dialog have U.S. for

Japan in morning the as third this announce a In our from received are & doses partnership world. deferred an order Japan. And Takeda cash for of with the governments billion financials payment quarter, accounted We are to have in Labor of XX pleased those Welfare Ministry very around the we Health, for we that million of signed revenues. $X.X have of

our Let me the R&D pipeline. now We Phase vaccine. September turn readouts announced to mRNA-XXXX, positive broader our CMV in Day the at X for

believe are presentation, We you vaccine a Vaccine has study our in on potential for in X that would Phase billion U.S. start owns which drug April CMV global I $X refer is of the the billion. developed There CMV we've is rights CMV, track Day number our in to registration pivotal approved to for it communicated peak XXXX. annual one we $X the sales the mRNA-XXXX. to and between defect and cause and no vaccine Moderna against CMV world.

OXXX of underway. propionic about that study acidemia ligand the PA heard disease, study. our X or R&D activities for at patients Day, many In recent are now intratumoral you Our is Phase expansion protocol rare and the program have amendment Phase in X doing start-up

that continue enrolling programs dosing pipeline and patients our of are also were ongoing. All and

Let this a through thoughts. slide on few few financial in I will David numbers the share financials. minutes, go words a me a finish but with the wanted to

Thank It cash inception we company's history from course to you XX and in is to billions dollars Moderna. science which in product product operating cash reported mentioned I that the supply investments that years generate our or after morning scientists, am the to quarter you provided company. this of receipts flow supply in after has believed this all cash we been have $XXX X, investors investing of for the I approximately pleased has after If cash activities report and quarter by the for deferred reported Slide of development. been $X.X agreements agreement. have business. and our to by QX of coming first that positive of in mRNA-XXXX. operating turn to earlier, we third million we millions $XXX As This received all activities in the booked revenues flow of billion enabled This company provided all the employees, in in to by

to Let me my closing turn remarks. X for Slide

to As broad a pipeline in accomplished continue have that to of October Moderna, have a XXXX, progress continues a snapshot well. and we lot

X, have enrolled vaccine, AstraZeneca ongoing and We with Phase the programs now positive trials X X cancer studies. ligand, full Phase with and mRNA-XXXX. X Phase VEGF We seven XX fully have CMV, OXXX now personalized Phase

Our vaccine franchise have the addressing major programs six in needs. unmet development,

immuno-oncology We have disease in rare autoimmune programs four two five disease. in programs programs in clinic, the and

been XX,XXX Our and stronger foundations with have patients our in never trials. participants

employees. X,XXX over now have We

be Merck, have historic have $X what accomplished proud turn the company. for We we Tal? billion. now few have where and I'm clinical end I over will a of of of international are capabilities Tal sheet Vertex. and and partner so Moderna. our quite companies The ROVI strong and updates. we next and balance months with very capacity have partnerships with to to Lonza, about manufacturing an AstraZeneca At like we a September, Catalent, far as we and it going to talk weeks stand strategic

Tal Zaks

everybody. Thanks And you, Stéphane. morning, good

we give conducted. me has remain that. our a Phase final starting share at and vaccine. overview Dosing immunological quick progress XXX being Once we while COVID immunogenicity is completed, The with of pipeline the ongoing. is results, X Let will participants in been our you but have looking safety the blinded we and testing study

prior reminder, study. fully I Phase start some That X with from of to and the of the details safety will enrolled, COVE data a this have is now trial shortly. course As our regulators share been shared

begin forward our take positive select data Day in microgram our R&D to September X which XXX in dose our data we enabled at vaccine, to mRNA-XXXX, Phase For and trial, CMV shared XXXX. the annual pivotal X to Phase expected the in is us

For results X. preparing showed Zika and we vaccine, positive Phase the our X for are Phase

vaccine study dosing following age aged pause disruptions. to toddlers front, On Phase happy resumed XX a pediatric our I'm hMPV/PIVX toddlers. was has announce that the This to is to be that months to first to the given related XX COVID-XX Xb mRNA de-escalation

the In of our participants adults enrolled. in first the study RSV cohorts has been of Phase mRNA-XXXX, X fully now vaccine, addition,

and another R&D a the cohorts annual those and core hMPV/PIVX de-escalation plan Chikungunya also X therapeutics, age Day surface data Phase our antibody secreted is September. modality, positive is to program of ultimately from in the systemic study an showed reminder, the similar also the this In toddlers. we during As to study cell the additional

not that significant safe and accumulation was levels weekly that of demonstrates This but a therapeutic two productions. protein, lipid secreted between dose. the our Importantly, of nanoparticle our led tolerated week systemic potentially of after further was of a antibody second we administration systemic ability and doses a no a well to platform's only dose in seen demonstrated result clearance, repeat dosing. regimen I'd Chikungunya the rapid increase with for note as predicted

starting X and treated patients the PCV. the Cohort in continues B also melanoma are is Cohort head-to-head of PCV -- in reminder in the of our updates vaccine, and Moving is Phase with across Cohort exploratory to tumor cancer adjuvant cohorts the various from the X is KEYTRUDA enrolling Slide expansion of ongoing. types adjuvant our the candidates A and The study melanoma pipeline were combination D follow-up modalities, four in that who in ongoing. Phase alone our in with A versus the C personalized randomized and trial patients. KEYTRUDA monotherapy the Cohort setting X with

been of Phase the on study. patients in immuno-oncology, we Recall that focused is expansion dosed investigators along to this moving happy forward several trial last team clinical part the that intratumoral our I has and study this support the of month, believe just report For initiated I'm have productive. ovarian we the X the very with

and start-up Phase due the In following also program continues Triplet have intracellular modality PA resumed for to our systemic dose program enroll study, the modality therapeutics this COVID-XX. Our to patients in disruptions in activities X.

published study Nature addition, this on In preclinical program. a

received VEGF Phase with pediatric take designation our For that that next X mRNA-XXXX, candidate, partner-led Phase are the KRAS And FDA. finally, rare studies programs, regarding Interleukin-XX we at Day with from ongoing. are would Merck all we and R&D the generation and which our forward a announced recently X recall Xa AstraZeneca MMA development Phase program, the disease

pipeline. So bringing in clinical modalities note of we number currently that three to didn't that development Slide across different of programs preclinical our X during eight snapshot review, is total the development touch XX. please a programs upon And the

details led response detail we me the more the and vaccine protect the human the into mRNA-XXXX, mRNA-XXXX, us the high across expectations, primates COVE a can of and on to X the Phase is lungs. antibody overview average trial dose all more and and to titers we broad robust adult titers XX hold where in our taking meeting non-human seen are. XXX a across were And completed those levels in has a COVID-XX. virus higher neutralizing age the let both I'll these immune demographics moment. of of on In than in groups our species Slide observed sera. move microgram consistently nose So give convalescent from and against you clinic enrollment,

The safety review England results across microgram Medicine. been Phase and the data were the me generally New that Phase briefly Let published cohorts XXX mRNA-XXXX well X Journal has adult tolerated the as in safe at of X demonstrate. age

What relates after were self mild-to-moderate in adverse were the As tolerability, site moderate occurred common it local dose. received stimulate frequently the and and with were reactogenicity antibodies. chills underlying most majority note, in in I believe more severe who common and above injection One in flu-like age solicited severity generally important levels fatigue, systemic and XXX an And was event is events severity and Of in of the expected. mild-to-moderate which response pain, high after to neutralizing is dose the to that the limited. adverse and They're the potency headache, are second fatigue systemic more that transient myalgia, second solicited age of the dose. these nature. immune correlate cohort microgram symptoms they XX

and events reactogenicity older trial we still and adverse in not while profile were any concern for small, patterns younger safety of these no there labs. serious vaccine-related numbers see or between are did clinical Importantly, no And in adults. difference this a

I relates to points the the data. regarding it make immunogenicity, three As would

of level older same antibodies First, adults. younger and we the in neutralizing see

the been receive finally, infection. And vaccine. be COVID-XX are we ill and expect in levels Second, to those to with than large everybody levels we on average see in had immune by who higher whom blood seen the the who and of these consistently second these people

speed XX,XXX of arm risk a which significant include good be of These average durable old, or and the was on expected vaccine inclusion subjects criteria Now antibodies The if this the in participant boost. I our achieved and being this And microgram participants. have number are slide that COVE at-risk years from as was chronic infected. are that enrolled those COVID-XX the be study Slide under Every but the overview mRNA immune found a our with quickly worse shows T will one-to-one study, points risk get X from is high randomization see follow were you And XX the XX between of than XXX and at disease. place fully noteworthy in that risk of are cell to protection. they to placebo. puts old levels website. higher the of one. you supports proportion And should stratified with for -- years people over conditions factors us outcomes speaks Phase to timeline, now can upon full of XX in of believe an the protocol quality response infection,

very evenly participants do close middle. left at right. can So our American in from the NIAID of and we of on study coming Hispanic recruitment diverse seen And that how African work participants hard Age about our X,XXX team, the census our breakdown sites the successful similar slide. XX% shown note, proud Latinx this enrolled And is We're our was study the of are participants collaborators communities, did trial or clinical of which and distribution of We've a distribution side country, is of XX. on see as the is led to to demographics? with than X,XXX representative the you two-thirds of the clinical and of diverse terms participants. the black trial in older of gender to or split, the and population,

greatest and a risk of risk over about The what is participants So factor factors of age, were the severe quarter disease? for XX. COVID-XX age

risk, participants I There in at XX% that virtue severe should disease. conditions. include these cardiac with XX%, it, get in risk XX% such the the they would of disease that lung of XX% are obesity over at participants co-morbid at younger, having conditions, but chronic at disease in our the put living X,XXX These still way another trial by at addition, risk of conditions shown and people study at all note XX%, looking the significant infected. were XX% chronic the In on outcomes chronic strata severe of of high worst all, of of diabetes looks right. are at with that which is breakdown

older Now do that you realize proportion conditions. the in both the independent math, the a significant risk if participants factors you'll co-morbid and of an COVE study had age of

sums XX up. Slide So it

and study Our people our with parts our find make diverse the the and Phase nation world, themselves it. many in X extension populations up COVE many and that is representative many identify study of by can could of

our what to COVID-XX As me we're on of results few anticipating vaccine minutes plan the a analysis let the happens study, take statistical next. review

a on XXX cover events. XXX in final plan the vaccine or analysis there greater. interim at success, and events based first we As you of need XX% can the assuming have triggered to vaccine is know, that order of to rate meeting XX% statistical and efficacy At analysis graphs two many the see analyses XX%. From interim probability show on the you the we XX will hurdle, a of a that efficacy at of left,

efficacy well. true of analysis, is the required as the XX% is this hurdle. efficacy actual At of XX% is vaccine XX%. or vaccine statistical probability of greater here is there actually if an the meet element meeting So chance second the And interim to

the analysis confidence. a in And is is analysis, final in is least But all that imperative that FDA efficacy the assuming again, primary XX% efficacy XX% graph, meeting true vaccine our the final degree XX% efficacy, crucial than we'll we assumptions endpoint are higher. guidelines, of also high on have boundary need we or are these about point of to these that is but I'm rate interval only statistical once probability the or conditions remember true exclude and be XX%, back efficacy, not point to the by the to of confidence have talking crossed, point the a about we the a high-XXs, that confidence in sure estimate required. sample, XX% do not have higher I'm this as per future. For initial vaccine we at is the of of what's not an that one coming And this ensure estimate the driven

outcomes; interim analysis study than statistical to proceed XX% full three to submission, the enable blinded the us the be each are meets regulatory or to at would The in the to either there trial potential hurdle, may the accrue greater trigger first study and analysis and is the the next interim statistical which data the futile. whether time. required and to in XX% remains second, and at then evaluate continue of milestone course with is meet hurdle So this to the not continue study the determined

have the program, As our committed today the we We'll and announce results study we consent throughout interim we transparent. our transparent X once and and next been to the first Phase occurred. analysis informed has on X website of will form to be step continue the have released Phase clinical

pressure the by distribution a the we're from fact driven results on that ready. standpoint, are Now the

existing We other for used nothing infrastructure. There required years that expect already that mRNA-XXXX within many be with distributed vaccines. is hasn't been new

to And expect to temperature's With small we of XX mRNA-XXXX year, the conditions ability over six week for a in prior handling for advantages is us package hours a U.S. months, temperatures this Specifically room the minus end after to configuration, of special required storage the to vaccination with includes let boxes it No any up to to take or to refrigeration of that David ship of conditions dilution this ready celsius or to to approximately financials. quantities you that, eight me the mRNA-XXXX. turn housing XX vaccine, doses degree allows to of and do ship for have and two XX the million by up in fall. large through

David Meline

Okay. Thank Tal. you,

to mRNA-XXXX in customer operating potential months XXXX compared for Total ended same property increase driven Turning to of We of the total at to customer million for equipment compared billion was of billion period ended million $XX in September used primarily $XXX the by The month QX XXXX compared nine $X.X to $XXX were to investments and revenue primarily deposits quarter revenue and XXXX Slide development $XXX prophylactic to mRNA-XXXX. of were same million periods, and net for mRNA-XXXX. the for for revenue deck. for in supply the in of for nine XXXX third in period $X.XX same by $XXX The for received for QX periods the months end QX. $XX preparation and from increases same QX September and compared in million used driven XXXX for in activities both months headcount XXXX, expenses grant costs set-up for nine to months a and The three $X.XX period to Total the we the XXXX. in XXXX $XXX and million billion The XX million purchases September mainly as pre-launch were the XXXX focus same QX for a to modality Research for by XXXX. for $XX million periods million in was XX September ended both XXXX. billion increases Total increases revenue XXXX. was due personnel, nine three with outside for period $XXX vaccines activities the supply September of Cash increases for expenses ended in the were potential months XXXX. provided XXXX increased in mRNA-XXXX were and compared $XX $X.X Overall, for periods $XXX $XX nine of due the of to cash cash compared nine million globally. $XXX was $XX of both XXXX. Expenses our from and mRNA-XXXX. compared ended expenses significant nine buildup. increased for $XXX the the activities for ended associated by million inventory ended compared September result month XXXX. million same month million development administrative million both clinical same received cash deposits reversal in increase in period the services a were of with $XX XXXX for to XXXX. for period and the cash accelerate for million months operating provided General the in to saw mRNA-XXXX. for a Net to million by to is in driven was cash commercialization for the compared development the development BARDA used period Research XXXX million mainly nine expenses month of in on

information flow selected on cash Slide XX. to Turning

On half and consideration and and nine the from in filings. million and take equipment year. information was bottom we quarterly also of our when ended the month evolution the to operating page, QX $XXX for QX And this property quarter items Cash part, September of XX-K for the assessing activities this and provided by XX alone. of the period XX-Q particular for into in purchase the provide $XXX in third present trend the trend, of million on we top

customer in substantial as manufacturing in compared potential $XXX quarters million QX around making of of cash $XXX increased year, deposits are $XXX activities in used mRNA-XXXX Vertex this for equipment was activities Excluding in upfront purchase and with commercialization our third in global quarter. we to compares cash to supply the and for previous candidate. for The investments operating second QX. used the and property million received vaccine of expectation COVID consistent excluding of payment, potential received deposits million is quarter mRNA-XXXX the This in and

overview commercialization Slide with activities. optimization where On me Slide to XX. we listed supply have Let agreements about an to today. publicly Please give XX, see we announced turn regard that you stand you now

agreement a with XXX for Japan As an reminder, these million option confirmed the XX an additional Canada for XX announced doses. million XXX a We with additional with include $XX government doses for has options doses. for in doses just million. million U.S. deal an million the

have also countries and with Switzerland, several We been have other signed that have publicly agreements and Qatar, Israel there signed agreements that are disclosed. not

are the placed around thankful trust We for to the world have us a deliver governments in the vaccine for countries. their

these including our All the agreements million for billion, revenue and deposits of provisions deferred 'XX XQ contain contributed have of U.S. value from to $XXX $X.X government.

doses. We with Union XX continue work to with are pricing ongoing, proposal. million in to the discussions are we advanced tiered the to countries with European million supply on including other also COVAX XXX where Negotiations

As anticipated X executed fulfill contracts at agreements track per for remain $XX $XX two a in were between dose for per volume to or pricing on and $XX vaccination these We reminder, $XX million billion with smaller with supply course. or dose doses with XXX course XXXX.

AZ. supply Turning $X.X payments for well update compared $X.X in billion as customer recently financial XX. was for by Vertex change range in and to activities QX and of net mRNA-XXXX now upfront by we potential to our basis, billion. the primarily The announced in XXXX the as overall collaboration agreements update deposits expect cash increase our with the of driven provided of operating now equipment on property Slide On and in to purchases an positive XXXX

and to the individual of outlook. in you the our outlook. components on more Let remain candidate excluding our color to me our prior With ongoing associated portfolio, vaccine provide activities, our COVID investment we financial on track regard

approximately of We and business and in development levels reflecting This expect with upfront activities and prior from activities entirely by of related property is improvement outlooks. as billion in net consistent outlook. to an be operating remain used billion prior XXXX, investment payments purchases cash equipment driven $X.X change $X.X

the Turning mRNA-XXXX now our impacts financial rapidly vaccine. to advancing COVID of

the to and licensure side. scope research activities agreement. and development scale-up expenses drive manufacturing that technical fall primarily First, These our on under activities to of COVID the are vaccine the development and BARDA

close As reimbursement, these matching not of we expect hence, relatively to cash we separately these our do impact expect XX. shown are materially and activities Slide and not on expenses flow, a

at vaccine-related primarily U.S. looking in the a be investments, for to COVID Next, the internationally. manufacturing product commercialized and net

We expect in $X.X investments expenses and XXXX. in investments the production activity billion our of This the $X.X the approximately materials capital related cash to balance COVID-related to be with to impact of network. includes raw $X.XX in billion billion

of cash Including we purchase and the to customer from by sum net Additionally, billion September, and in this to positive received investment all total $X.X sum $X.XX total before end provided deposits our cash includes billion. agreements. supply expected The deposits. which billion business used for by of initial of operating billion, equipment related total contribution the and the commercial of net currently $X.X is activities to infrastructure $X.X costs Moderna's expect operating activities to to build-out used for billion of of property consideration customer $X.X

number continue expect to We we further this to receive increase deposits. as

Turning now to Slide XX.

quarter equipment the the benefits in United expensed States. to the an is period expect future This probable, cost million, for determined use we areas with of Slide of that, is associated approval costs The pre-launch XX program the will general move raw our progress mRNA-XXXX, IT the capitalized. materials. related there inventory with extent In heightened to acquired production and infrastructure. which an with some currently and we After areas, raw R&D several to assets approval of reported costs. alternative include realizable. mRNA-XXXX XXXX, that as of are forward. fully incurred. towards be largely key purchases inventory Use as an of will change our evaluated we are with Emergency will impact our Costs assets economic or example, expensed increasingly for associated well pre-launch and of from materials as leased commercialization includes property we and Authorization assets As accounting these in expense be we that highlights commercialization production will results be inventory capitalize for event, $XX interest Examples to of third sales in approval to

assets and as recognized deferred revenue acceptance has with was future to and the BARDA transferred as product control deferred the Accounting mRNA-XXXX. model needs This to have longer to follows recorded approved match acquired costs QX, such approval for are supply PP&E at for approved deposits expensed be no the of customer regulatory will where will the incremental quarter. we are commercialized. revenues least product QX, event customer when revenue product and expense. billion alternative $X.X assets assessed current of approval incurred. supply After product perform as customer occurred. incurred. associated not of In or potential are when products Assets a recognized that grant potential before mRNA-XXXX been Moderna expenses mRNA-XXXX In the as other recorded be required use, as recorded yet closely fact $XX reflects has of No On will we be reimbursement they does as for a in recognize meet will PP&E capitalized. we revenue be services we production sales, million of are of revenue immediately and platform

tax back now we expect and valuation update. which tax realized. $XXX to income assets in realization and deferred allowance, will and benefit federal reverse portion reserved were a accumulated likely approval carry the I that forwards. financial event, more our tax utilize than of release statement. be yet And concludes This concluded the of net NOLs, had as million to million fully regulatory state the a of net assets, XX/XX/XXXX, our net allowance And After which result will not to As we the loss call we operating in not $XXX deferred as the Stéphane. turn of was of or we

Stéphane Bancel

entered years few and the David. are getting strong Thank different cash to to a focused an of across closing, but look we both at step at I picture, race virus, to not been weeks, market $X.X a for strong like with very But in The and portfolio to believe to would Across you, few focused important The against modalities. vaccines In the mRNA-XXXX next the billion, six minutes. Moderna of my the future, the in in Moderna. on has vaccines. time. the incredibly pandemic. and in look rightly team Tal look back few the part clinical approximately world, and I diverse Moderna therapeutics at position, so, a big on is role all, next with not XXXX into therapeutics a of position only the only XXXX

have We on a approach always focused reduce risk. technology to portfolio

large candidates. development XX science, formulation. over in and We have investments years LNP mRNA since nine sustained We inception platform had

broad We a IP and have established strong portfolio. very

in owned fully We materials fill investment allowed raw us clinical to large development. at speed. of that We unprecedented have go needs with plant to a for scale sustained and integrated process our from all vials

ensure thoughtful with for at got that look risk, flow cash support mRNA-XXXX, free XXXX two very citizens. XX as Warp the we including exit year XXX ordered a finish We important decided will to balance U.S. companies launch end from. It the pandemic U.S. of that mRNA line end back fiscal plus to will position. They the now, unique of decided has cash Operation we believe They Moderna XXXX, September the market a at Speed government stable diversify a I $X hand at we be if two taken XXXX. vaccines the The over very one generate government technology. OWS. companies the XX, the strong U.S. million is COVID in a we to that XXXX. of approach As per That should doses access. only the or from to of was should made billion months vaccine I in technologies, to have crisis

large. the Moderna our technology, the us, from thankful the Without we're rights to very mRNA-XXXX. corporate large because more position the all plant. intend unique the company our implication hope of scale profits been bring to to built a market. in manufacturing Moderna We no the We realize of for into thought; process has and the COVID-XX We and strategic will should I and returns Moderna vaccine. have from cash lot sales mRNA relentlessly give an scale robotics, to that the the placing development vaccine believe government of in reinvest the in trust process worldwide U.S. in could at science is development a medicines are long-term our the grateful the development, in for at XXXX. other that partner, pipeline are have molecule. help. digital, invested commercialize information end We and to retains

approval We way $X year make that Moderna each manufacturing the class a company. medicine fiscal credit to will XXXX or and use believe mRNA since commercialization five XXXX. be no day have years about year during chemistry be sense same material approved cash. use of of about a the product over manufacturing a to said, of The do fail the one, with It Early lipid. vaccine always class to billion of we made zero mRNA-XXXX always year vaccines. use We mRNA recognized the will this we inflection would medicine. medicine history. Think balance technology our this and it an derisking change on, it that I team if Moderna's one-product important We We same this be will for to I XX be mRNA. very changing safe next that efficacious platform. been will for new We vaccine. in formulate that forever. to the limited could process that new leads the in is from growing our in process provide starting our of could to entire in same knowledge entire a the five to be the most the make unique believe what a same mRNA The last chemistry lipid. make the

our for the strike the will deliver mRNA long. and thankful to had clinical NIH, we to conduct We their the patients your of wait mission a we band. Catalent, is the when take participants to and generation you. we create clinical in Thank partners; for for on XXXX Lonza, PPD, questions. very trust medicines BARDA, promise now the many of happy that new for participation science be ROVI, clinicians team. trials transformative trial In I'm Operator? Our every our trials. single With that, didn't

Operator

[Operator Instructions] Salveen of Richter And line Goldman you. question with from comes Thank the first Sachs. our

Your line is now open.

Salveen Richter

vaccine. [Technical Difficulty] COVID-XX

vaccine COVID-XX, just from would just on you three like commentary how Dr. green study? given the talking just about the potentially intend light unblind the then think timelines at a some Thank So about I here you. in the recent for of to your January vaccines? looks the thoughts And first and EUA, Adcom given full FDA on interim around post or Fauci the commentary, just secondly

Tal Zaks

this Tal. Hi, Yeah. is

Let me try and take that.

especially bottom them a I the feel participants for to of appropriate here that is an line I will be whom EUA obligation ultimately what we is COVE think have we they this to listened a had the occurring. benefit from work-back the cases contributed to. happen those week. themselves unfortunately, There here. be think the I way that for balance last the study, all way end The to And are think the an going to is of intently course, is think I to day, of there at

We are in increasing a of transmission. period

part the of long blinded how there and you data power more and could has can conversation events do that a with been you FDA. for an the doing very finding do of will for be I actually then to the detect of crossed for even right blinded expect analysis collect if than between is I that discussing that give unblinded if so the study that is you mean looking math, knowing collect data some trial. time but that balance to And post And what trial. bar continue the one blinding, efficacy, type rare example, still safety you're on

we're And find with that these into to going with of confident So them FDA. go to how as a together will this. lot balance that I'm the are think right of we elements to I having the operationalize conversation

relates I on it in the to think the As to track timing, interim first we're have November.

I going additional December to that I for we're expect unfortunately beyond. be in think cases occurring on and track

of threshold demonstrate ensure anticipate think FDA which and other And I with we months to data coming and right so rest and totality will agencies vaccine and dialog available. for on efficacy the the the I a ultimately by the will the safety in cross process be make the efficacy regulatory that

Salveen Richter

Thanks, Tal.

Operator

our Stanley. from Thank you. comes Matthew the And Harrison line next with question Morgan of

Your line now open. is

Matthew Harrison

something questions the about among [Technical this somehow leading in we're up the what confusion or recognizing about this morning. behavior, people the features at two Difficulty] given in this guess information I question, I can rate think which think there event you seeing the of the rate. potentially has that Pfizer comments to we're then And towards the boost on certain seeing earlier to come be of from is comment attack rate the study? population Tal, this whether me. different taking seeing some general week, lot about studies mirrors a people in is due population? it's you're lead all and the related may may all concern in related lower I than else attack if functional a investors of what that a these lower the that general unblinding lot

functional the obviously could the especially talk And a the you label we've fact wondering about from So if X Phase have what you a have placebo-adjusted have unblinding? do tolerability to related placebo open study, you seen was data Thanks. if study? of you idea I better about versus from concern much that an

Tal Zaks

Thanks, Matthew.

try and you me data. a see the Let of sense give I how

so COVE to that in the participants surprise of sense of the zip emerging First co-morbid in conditions. of older from a all, the because demographics achieve codes with what is minorities data subjects from. trial been look at we what if do rates mirror my coming are people, the see you our we've many where having not study, able those It's attack

it's down, more on slowing rates rates par with data it's our expectations, of for unfortunately paradox there. worse I doing, that with this subjects So the the the get off not but there current large. attack unfortunately, writ we're think And attack math will out

So sense. that's my

everybody field and which concern regulatory yes, a and we'll how is the is not that -- I address about continue participants The is to to coming all that. in of does raised balance play unblinding you unblinding, eventual the functional which had, think I this versus there I Now the dialog data be accumulation the into have of to the expectations, share that just question in I've is weeks. with, struggling in think first us tried but

I I think optimal believe to that get transient flu-like event a don't that some dose We the may it the do, chose to degree. sense se. we opportunity all lower this think worth leads per rates, it's people this in for to is we disease. but certain prevent a symptoms,

recipients is if biggest that you if be would be that If anything, infected less us that they my their rate. people getting they at something anything, and recipients modifies placebo risk efficacy would against of bias behavior, would behave such behaviors getting the of then infected. think more vaccine the because risk would and that, think expect concern be I got the at it would vaccine

significantly I rates. don't anticipate unfortunately, picture, we at from going expect effect. to event anything, changing If the said, of statistical hurt I robustness have adverse I've look on and track, this for it to a So data, being. think where But be us. I we're And be as if least at the it shouldn't any should macro the ultimately

Matthew Harrison

Thanks. Thanks very much.

Operator

you. comes from Thank Ted of Piper line Tenthoff Sandler. with question next the our And

Your line now is open.

Ted Tenthoff

see the very in to company Amazing you your positive. Thank bringing you for thank much, flow all turning huge Great. milestone. and forward. of A hard cash work XXXX

the with cost quantities sense for Let you're vaccine or at talking a that about for year the of price Lonza? me get you. next at Thank

Stéphane Bancel

Ted, Stéphane. it's

are said competitive we reasons. we've As obvious goods cost disclosing of in not the past, for

that So to I won't be able question. answer

Ted Tenthoff

enough. Fair

data Looking to coming forward Thanks. up.

Stéphane Bancel

Thanks, Ted.

Operator

line our Thank question Yee. you. of from the next comes Michael And

Your line is now open.

Unidentified Analyst

the that question actually you on event confident actually I time, and know and on everybody that. so feel it's do in that do numbers every the do believe about November? missed the what more Your that And seeing very so your you're related you think event nervous is about rates, with you you're that, timeline, a you day going actual on I therefore, is based feel part competitor said maybe to Difficulty] you think competitor. [Technical you know rates?

not And on comment interim, just Maybe you comment maybe hit on has a I'm actually as And then make high will don't a what spend, maybe NRM do pretty think secondly, about So general? concerned. think going what in just that that. just well? you've is and we I make think mean to that's if But so with mostly commented that too I about why because alpha a it comment folks? actually for about that make is the if the

Tal Zaks

this can't competitors. you. know their is, Thank I Yeah, data. Tal. don't Look, I about comment our

we're But small repeat from There what I think leave confidential I'll to can we Moderna being I what which at and of models the track said tell sophisticated to come, that's these expect, pretty So on I overall of that our zip We is minimize up. following counties data participants in. That I course those of team coming can to cases number the here. that's speculation for the that a you them. of course about sense. have codes do we see kept expectations. and since aware the following is are

in So as I have track think on be some should for time we November, we articulated. interim first that

efficacy. going even mean interim of You doesn't hit chance the demonstrate XX% easily stats of raised it in of fact, vaccine batch is We less of the And actual the what that that for That's to point back about interim, an efficacy luck or than asking a and on and come work. interim a the efficacy. yet the kind doesn't of hitting XX% how function a thank the Hitting data not be vaccine first the XX% vaccine that. you second you valid and the work. has of the distribution could Not element on it doesn't and mean is an see.

would same it's an to less I it's you dispel at you're cross maybe statistical on crossed and the Once peer final that the statistical standpoint. the than from mean etc., conservative is correct. interim powerful the a we think the conviction you This have fact that you had spend, The opportunity a final. alpha have design that boundary, an notion. a boundary doesn't

the the time. of think think way continue Data the I will blinded period to I point And increase Now with will the accrue. blinded, long for we we as and irrespective cross boundary, the trial better continues more which certainty is about here of to at on all level better data get trial. have of of a endpoints as trial continue we will data the the more the the and

to can of allows So there such the is basis delayed in so communities. our ultimately there down people me, just go in path interactions of out is that interim ensure when need have to analysis access crossing us and not regulatory first to is and a the we start confidence proceed that this for high that doing regard, that the

Unidentified Analyst

Thank you.

Operator

next our from question Wang the of Barclays. And comes Gena you. Thank line with

open. Your line is now

Gena Wang

safety is see to in two so, Phase blinded regarding how that also format? compared questions you do X then profile? If Difficulty] the a And the interim [Technical analysis.

you is missed is boundary? interim, So second first And interim? if if the first for the -- this futility to interim, interim first due what eight the to then four the weeks hit

Tal Zaks

I other you continues. The regard, also that safety, yes, don't see seeing expect so Safety not in would trial so tell sees that unblind. been trials, the we not that. unexpected, the Monitoring in sees but by a that and eventually trial, Data U.S. totality appointed NIH that's anything we the OWS-sponsored the take blinded parallel remind me Board and can Let unblinded in just I our Writ when you far data. the both fashion. the large, I we're the surprises Independent And blinded

not the is between question the matter Your it's and second timing second first of the I months. weeks a think around interim,

because transmission is down. that areas, longer. But a for can't future precise I go weeks, hope this I it's the more they rates in be obviously not Now function of and now four

that futility, in the specified wrong It's to boundary of the to was think protocol. terms is specify this way. to appropriate is it I the felt degree the going show we In that

Board, a can I Monitoring the statisticians that panel say several that, you've Safety Beyond several Data reason got clinicians. that have you experienced on and

they're expect So it closely. their at it when exercise looking judgment is to and where them I experience

Gena Wang

you. Thank Okay.

Operator

the of from line J.P. Morgan. from Kasimov And comes our question Thank Cory next you.

is line open. now Your

Unidentified Analyst

taking Thanks Cory. for guys on my Matthew is question. for This

ultimately light to and of the subject on rates mix of for geographically I'm assumptions your tracking proportion the COVE trial with infection event to with patients that Just expect commentary are symptomatic? become are going in SARS-CoV-X that infections. what you wondering

Tal Zaks

Yeah.

make let based routinely spike me me infection be swabbing is because and So PCR capsid rate -- will check first protein. as determined on people symptomatic a by just to self-identify. versus tracking simplistic cases not answer form. we're maybe nuclear comparing distinguishes let later people antibodies and The against infection of in asymptomatic that The immunization foremost serology between

So we parameter primarily the Hope are that to that the aware answered epidemiology. is as that begin tracking with. the the infections, And it primarily symptomatic relates question? we're to of

Unidentified Analyst

Yeah. maybe I just guess to follow-up.

are from rates So what when the data the codes, gathering to benchmark the that are you tracking zip you to say it zip that outside is trial codes?

Tal Zaks

data totality the together. Reporting we've compile the of of independent of a emerges and rates case that those teams -- that various create the expert from rates programs couple predictions. and here infection It's and panels sophisticated surveillance to models got

Unidentified Analyst

you. Thank Great.

Tal Zaks

on that me If under I the confidence. what it that at complicated number the hood, tell this a stage, close that's black looks spits out daily basis to and see ultimately the very to what's can weekly you're asking that describe me. it's me But you that gives and we for number box a

Unidentified Analyst

Thanks. it. Got

Operator

our of And Meacham with Bank the comes Geoff question next from line of you. America. Thank

now open. is line Your

Unidentified Analyst

you more guys. own agreement, do just about plants manufacturing price allocate What just other the this What's internal the COVAX? the your there what's taking Can supply logic suppose I guess, external specifically, between the is and Japan the Norwood limit of the would ensure supply of our questions. Thanks to being and a talk And on consistency seen talk and your structure the agreements, This in in doses of tiered OUS tiered set can a how Thanks. pricing versus And are logistical vaccine if any Geoff. bit you sites? with you to supply agreement produced on for certain Hey, vaccine Alec amount of And both for constraints launches? geographically? done the about plan agreements? that a most for a on proposal manufacturing would I produced look between lastly. And like?

Stéphane Bancel

Hey, Alec. It's Stéphane.

a I lot something, questions. If let it's of me So forget know.

sure make do available COVAX, is is to the to on vaccine around So the what we want world. that

based be different the the a age you think we -- very and I development to we chance across early important. on data on As believe mean that protective know, has it's vaccine range,

to as Gavi can. The past. vaccine be And pricing so we done we typical has want what available many the in is people to tiered very the of help as

As and sure aware, you being Gavi are COVAX by I'm is run CEPI.

so And countries by is middle-income countries to propose and developed price to being countries. high-income the price idea the here paid lower is a that than countries low-income or

is that so basically And idea. the

And low-income we the provide and are a those disclose want to But to position for prices a course, company to at ongoing able country. that make discussions COVAX. we're so cost sure are today of because a lower we vaccines as with mid-income not in

biopharmaceutical -- quality Moderna Lonza at is a what on the New or And the product of is same in at many across in quality ensure the same spec. of would validation technology Lonza so board, say then of made Massachusetts terms or at allocation. that in you several in term I and terms that Hampshire transfer in in typical to the of done Visp have it's of organization, and quality sites companies a In is when

So We as New setup really regulatory in be is supply a two filing Moderna Lonza think such around. the supply U.S. term quarters to we to products of so are launch. focused would U.S. going initially time, we said can hold After Hampshire I chain the to supply in chain, going Lonza be on the for after the chain Massachusetts initially I in this say moved to and supply setup we chain, that just Visp the And the the setup focus past, outside U.S.

if U.S., in to and Switzerland we point the versa. if in that So the at U.S. can be some more we sold will U.S. product sense all need that to be we supply products from vice stage U.S. setup U.S., the international kind from the a of makes to ship have get we products import in the the sold chain products we more want to We into where to so the able

very to allows trying nimble chain So to that supply that flexible a and us was marketplace. your question, be to needs we're setup hope to react of Alec? the I a

Unidentified Analyst

helpful. Thanks. very Yes,

Stéphane Bancel

Thank you.

Operator

Singh Oppenheimer. from of line Hartaj comes with our And the question Thank you. next

is line open. Your now

Hartaj Singh

the for of Great. data Thank all you. presented. Thanks

quick CMV-XXXX. a a of One Just couple questions. is non-COVID-related on

worldwide for a a could year-for-year Stephane, talk Thanks launch how to a way help prepare time questions. organizations, as got governments basis you of about wrong like-for-like basis them thinking how you just that, think us for for of comes on assume to that part from with it worldwide kind you forward? rights worldwide is on XXXX terms with worldwide secondly, that bit Any then since to have how order a grow You've XXXX, on you when COVID-XX the in comparison you versus going of And revenues XXXX? depending your more -- to, XXXX? about just even initial the Can will basis. are of little vaccine, the the be sort trial a with one-offs that

Stéphane Bancel

Hartaj. you, Thank

So pandemic I the refocus on one. on Hoge time lot to since organization, a beginning the, would non-COVID say, Stephen has spent of of that the

COGS I has Moderna's Tal pipeline, kind for and the of Moderna which time rest this X world slowdown And of over refocused us for refocused as from one both then and XXXX at patients. a all hand. the on into successfully think regulatory company Phase record X very deliver and course into we've in is of with study historic done and future agencies the to the around literally a to competing portfolio. on into of allow Stephen not the important the has most this on and product interaction XXXX and time the Phase computer taking our non-COVID

And been so have a what is, we done lot. quite we've hiring

a quite commercialization, so dedicated at so no have on of it's because don't asset right ground. we development, course that to higher we We've believe product look hiring the we've that the we Marketing because PCV market great to and the of we can that. all asset numbers, going have right our a teams next development to pipeline in CMV people been or of or the terms don't closer And get headcount so our given for the we're into scale do actually you the continue lot there already on to as CMV. we the quarters slowdown of If like of CMV Head hire we'll for very important is

do their could of about and of terms awareness, In know women to CMV disease lot CMV pregnancy. not a what do

to of much disease, great to more similarity in are given think I is believe Zika the aware years a and the between And is happened up in everybody I ago, infectious And and to post-COVID Zika. CMV people what's Latin given running CMV of few attuned where highly outcome Phase and the so we America opportunity a is going X think there re-drive while awareness. be, world the

what speed a the the uptake opportunity so to actually think a increase are we to for years preparing there's market before, prepare of And us CMV the the is which great by market doing. of I few

revenues, our then be phase to call, the is there of a I is which QX phase really setup mostly vaccine COVID described, an believe the endemic we of terms going we pandemic think in on as and boosting. In

discussed do different how a lot we community, working vaccines not to be medical the across long been in has the for. As we're going know

population. it And a once so we not risk once believe most who to depend do We year, year, probably be yet if it's especially high elderly every their most want to are the every going profile. going once the immune two will boost on to three at probably people are years, know

the we have all way that, to doing are run but We know to the no industry. clinical which experiments, across

If of you take a different vaccine will have protection. different duration

there's Blackstone the that And to to going contracts with people. going currency so to going for thinking the in paid a then actually right indeed are there's be be which be setup, for follow-up vaccinating contract I the pandemic have while way, we think quite it to boost. a about start you're I setup And think that

of kind Does about think that sense, Hartaj? how it. we that's makes So

Hartaj Singh

helps Yeah. lot, Thank a Stéphane. No, you. that

Operator

And from next comes with the question you. Thank BMO Markets. Farmer of Capital our line George

Your line open. now is

George Farmer

about you be mean, or morning. if happens Thanks my commitments be if comment And down taking you on I start Good hit endpoint something I get does wondering study, the certainly Hi. could the regarded do primary reducing following important, existing which Thanks of study? supply could as of on this severity disease agreement And was play, second your the for until do you quite very come do EUA what endpoints, don't full secondary COVE hit drawing if meaningfully of questions. you you you you you meaningful. EUA, into get do that? much. thought having is, on Have question an inventory wait my approval? could

Tal Zaks

So, take Typically stats if the raised. way George, the from is laid is hit Tal. you point are you you to out. get primary, Interesting -- get this credit don't the secondary don't

while I think have on dialog I'd be hard we primary, take a with like. but we biological the given I time hit if those of possibility, to exigent to It's more it the Because still discussions blinded is up credit ahead looking seen have I conservative data think the to so the one, have secondaries. we of go and we've then continues But which to anticipate in proximal cross there it, if and what what answer go the don't fail say for And this data opportunity the the agency case, going discuss would trial accumulating. we if are regulators. may course agency is far. we'd can with circumstances, the early, to be the will actually is very hit it's you the

question answer second your government U.S. we Authorization. the have is the Emergency once take expect and to kicks think in supplies I start the Use to would Yes, an I easier agreement would an one. supply

George Farmer

very much. Thanks Great.

Operator

Company. line the of from question Alan with & next Carr our And you. comes Thank Needham

open. Your is line now

Alan Carr

wondering updates Stepping as we flu us something flu around my Hi. if as around timelines details seasonal or in give to taking away for that be if Is that? could see a us or you'd mentioned that COVID, Thanks months a I'm last you all month can vaccine? questions. give program. more like it that you from some that? vaccine something both universal And you a any on going to revive

Stephen Hoge

Steve. I'll take that. This is

Stéphane Bancel

Yeah. Go ahead, Steve.

Stephen Hoge

last announced in I'll already influenza it two building from have seasonal business that data begin at we different strategically pandemic looking influenza. we're that to clinical month going we in we're programs. is remind and a you So do

response still as productive influenza ability And a generate so virus to immune to we're well. in the

We haven't provided expect clarity that we yet to on clinic. into when move program the

time. And do to on differentiated that reasons. platform think We viruses we do the even to still market couple combinations, substantial that better boosting. seasonal bring potentially because do our bear. One, a be need and suggested to can influence, second, those that we updates try antigens the of an can for other we will get might But both closer obviously, an it's unmet many with have a the opportunity combinations as we interesting need future in there provide and is to

And towards opportunity But excited candidates as update at by this soon so declare time. we're we'll clinical move an that normally we quite provide do development. forward development the we and as

Alan Carr

Great. the taking Thanks for questions.

Operator

comes line And from our you. Raffat Umer question Evercore. with next Thank of the

now is open. line Your

Umer Raffat

so if much a taking guys. I I may. my Thanks for questions. couple had Hi,

Journal positivity? from participants for for Is or did cases you RNA then slides England data, who at cycle the an rapid starting the in detectable the in Phase The one been with COVID mentioned the XXX infection nasal of got it X if X? we confirm And at if and finally, threshold primate maybe Phase the protection about First, I swab. easier nose Second, of XXXX one. know one-off have But there in see New XX? could you're non-human least PCR dose lung on What's primates. using any

assume base nasal of COVID? see the that So for is, I much. a actually very you I'm to despite symptoms, we guess swab could what case, positive at reasonable getting it test is cases requirement of one-off Thank as

Tal Zaks

Umer. Hi,

Let me those take questions.

number assays. number different I It's can on comment the I numbers across different of is think don't believe because really those I assay not assays. same characteristics, so threshold, meaningful part compare the don't cycle because Our the you it's can't

were first or right, since Well, blinded, and means. primate, On there the still the the Phase But that nasal with of nose comment the we're one two. on in question levels was primate rest case I can't think The low sterile. what a and X, participants on I in yes. on we've the all really you're relatively transient had swabs,

we by that that is confused about that have. think sterilizing I the high when sensitivity talk concept immunity, I we think

a block cloud inhaled swap on walking So me my well, of a It what getting do IgAs clear, probably on see aren't bunch somebody nose, Well, XXth some isn't me from and data timing and show am whole mean somebody in Street sensitivity. to immune detectable street on I'm I'm the ago. the got IgGs virus down Street, a kicking swabs that's our have question and that? mean and I up and and antibodies of SARS-CoV-X, got they're that a that I I've by the we virus if sticks and going if and sneezes I've XXth I just as doesn't

to their a The it and are and raised the reason we on you triggers when what measuring. for hand who our people So say trial, be measure then test tested. measure got depends how In you they've symptom to and the to one at right is sure events asymptomatic not really testing that we're tests. confounding disease. But not day randomly make of and XX people excluding only we're swab that short with just and occurs day adverse actual doing a that,

that I detection? as relates So it your hope to answers question

Umer Raffat

you much. Thank very

Operator

Foroohar Mani Thank of you. the comes with next line question SVB our from And Leerink.

now is line Your open.

Mani Foroohar

Hey, on know a focus on there a specifically I COVID-XX, my financials dive wanted has but of to been I lot little massive guys. bit. Thanks for the taking questions. in

about that million moving go base for to it XX I would the think to question I then should EUA about follow-up were out right expensed? the tempo hear this. CapEx what of $XX commercialization? I quarter PP&E a And here? the so CapEx from And back that be growing and of And did give next So how global XX that, would on have of would successful secondarily over presuming a us months the otherwise

David Meline

Yeah.

we that of quarter, capital terms that was which capitalized. was was the look XXXX-related quarter was invested you in So $XX the What million, which at I the mentioned, deployment, expensed. if in million $XX we three, had also

rate. run million total. And a $XX reasonable So think that's I in

some we're here launch up in finish we will that investing You for we in see on full the preparation place. and and putting as capacity increase year trend the

that prior approval. fairly through quarter expensed extent year, occurring into next we've not significant capital the then do more produced be of we until expensed quite the essentially course it's possibility a I of of cost fourth we'll that continues product including amount in the that QX prior of prior cost understand, zero that that we sold to is to deployment going as capital you that it's goods if anticipation deployed the an expect the And think from we're impact to inventory which the and post-approval, approval, in the the will the expensing, inventory that keep therefore, it's a may, start strictly of fair of have As approval. increase the approval. happen. to raw And I additional of production which would understand mind to somewhat, to of also in commercializing and as that materials perspective ramping investment, is inventory cost production, product capital And the likely we've is in of acquisition to but

Mani Foroohar

was PD-X the over it may the OXXX that of should top I hopping to then we mentioned. And to a when from pipeline. with get non-COVID helpful. patients asset What's slug data on really next if the have timeline the That's of Okay. missed -- ligand number reasonable an think on therapeutic? top And of PD-X about of on program? a approved having it

Tal Zaks

Let me try and take Tal. that. This is

that just So patient determined not but happen by it's on events accrual, data oncology, and I think the trial. is

And why so patients for where are how and very on it's really hard we've been me which we predict, clear is we. many have to

I I cancer anticipate that blocker. is once number have will these would patients combination tranche in of ovarian already think trial, the PD-LX the be a we on with sufficient of with next data and

our response once with sufficient should that have follow-up. for So patients be sufficient rates we informative

Mani Foroohar

bought of and for zoom and as have year, about portion has you Obviously quite financials. to think back how stock sales out COVID-XX, stock-based the And headcount of anticipation of you have get peers, Will helpful. force? the about up proportion should I think That's continue how as you spend? in scale? this as down that that, modeling them we in think how launching or compensations to modeling a over expanding we months? we a commercially for to absolute terms, Just either as XX the start infrastructure given relative in your think final many go Will the question, Great. overall should about modeling should the build pipeline a volatile our say the course R&D been to EUA of Just how to it should as of expense? next expense, SG&A it more your

David Meline

of we'll That's to would that guess, view trend I get And be guess question. to with a I that. I'd back to start you. stable. on have you I'd the very have get point the good to But back

Mani Foroohar

congratulations Thanks right. the all taking and questions, All success. on the for

Operator

Thank you.

UBS. Our question from with last line of the comes Navin Jacob

line Your now open. is

Unidentified Analyst

is This you Thank for Elana taking Navin. for Hi. question. on our

deliver secondly, vaccine the expect primate sterilizing transmission your through and question we've immunity? that to And broader viral impact infection in to what any seen XXXX? viral is, what see non-human then from think you be in colonization sort on will you of prevention So vaccine do or of from able your general a studies, do

Tal Zaks

Yeah.

good question. a So that's

of at the the demonstrate actually bit antibodies first what I they and to way you is say little infection. the the against least -- somebody about other will is enough you we to I the as actually anticipate a a hopeful that how able kicked think tell as for me it. we the before, nuclear X alluded think never demonstrate function parts of as mean, prevention immunity what asymptomatic antibodies sterilize. Let It's be What's be concept of I the asymptomatic. I We'll measured of a on test disease. from able It's the virus, That's virus, which by that the for maybe saw the I actually established to how Again, in serology, next of it. sterilizing easiest? to do? that. hardest? infection, show hardest be vaccine principles, measuring Phase demonstrate to in protection to to will to probably It's I'm severe is most just thing the capsid. What's to prevent prevent a but

they going if and to less spreading data. less spread. get sick, is vaccine I think that's the see at how about this, we're getting once will I certainly also so of math asymptomatic there while I have we have transmission. have I ability -- prevent order And do be to that But expectations. any severe spread, people I don't think is anticipate this the to be we I because symptomatic you're sick of what what because really the is we think And some going easy expect think of less measure to direct

and disease, viral in potentially the think least symptoms you the so see. -- more the fact, the And shedding the higher in I earlier at

complicated the equation that's asymptomatic So What we trial. based concrete infection be think is is to nutshell answer in on some prevent to to going hope serology. will through a a very show hard that in I directly measurement that we

of Krause symptomatic symptomatic to And which prevention you're hope and one should prevent Thursday, would show agreed that the will you anticipate manifestation. on severe if preventing that last clearly to alluded endpoint. disease, first should clearer the FDA primary -- be by way, We infection, even you that's principles, it from more the with based Phil

Operator

any concludes the for call turn Stéphane you. remarks. would to Thank that now closing back today's And like to session. I question-and-answer

Stéphane Bancel

operator. you, speak you support. day, and Well, Have everybody. safe and soon. a Thank your question wonderful for your Stay time your Bye. everybody Great. thank and

Operator

Thank concludes participating. call. Ladies conference and you this gentlemen, today's for

You may now disconnect.

Moderna (MRNA) 29 Oct 202020 Q3 Earnings call transcript